{"id":796012,"date":"2024-12-19T06:03:27","date_gmt":"2024-12-19T11:03:27","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/vertex-announces-results-from-phase-2-study-of-suzetrigine-for-the-treatment-of-painful-lumbosacral-radiculopathy\/"},"modified":"2024-12-19T06:03:27","modified_gmt":"2024-12-19T11:03:27","slug":"vertex-announces-results-from-phase-2-study-of-suzetrigine-for-the-treatment-of-painful-lumbosacral-radiculopathy","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/vertex-announces-results-from-phase-2-study-of-suzetrigine-for-the-treatment-of-painful-lumbosacral-radiculopathy\/","title":{"rendered":"Vertex Announces Results From Phase 2 Study of Suzetrigine for the Treatment of Painful Lumbosacral Radiculopathy"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }\n.bwblockalignc { margin-left: auto; margin-right: auto }\n.bwcellpmargin { margin-bottom: 0px; margin-top: 0px }\n.bwleftsingle { border-left: solid black 1pt }\n.bwpadb3 { padding-bottom: 4px }\n.bwpadl0 { padding-left: 0px }\n.bwpadl2 { padding-left: 10px }\n.bwpadr0 { padding-right: 0px }\n.bwrightsingle { border-right: solid black 1pt }\n.bwsinglebottom { border-bottom: solid black 1pt }\n.bwtablemarginb { margin-bottom: 10px }\n.bwtopsingle { border-top: solid black 1pt }\n.bwvertalignb { vertical-align: bottom }\n.bwwidth20 { width: 20% }\n.bwwidth60 { width: 60% }\n.bwwidth80 { width: 80% }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>Vertex Announces Results From Phase 2 Study of Suzetrigine for the Treatment of Painful Lumbosacral Radiculopathy<\/b><\/p>\n<p class=\"bwalignc\">\n\u2013 <i>Treatment with the highly selective NaV1.8 pain signal inhibitor suzetrigine met the primary endpoint with a statistically significant and clinically meaningful 2.02 point within-group reduction from baseline in the Numeric Pain Rating Scale (NPRS) \u2013<\/i><\/p>\n<p class=\"bwalignc\"><i>\u2013 Placebo arm showed similar within-group reduction in NPRS \u2013<\/i><\/p>\n<p class=\"bwalignc\">\n\u2013 <i>Suzetrigine was generally well tolerated \u2013<\/i><\/p>\n<p class=\"bwalignc\"><i>\u2013 Advancement to Phase 3 in<\/i><i>painful lumbosacral radiculopathy planned, pending discussions with regulators \u2013<\/i><\/p>\n<p class=\"bwalignc\">\n\u2013 <i>Vertex to host investor call on December 19 at 8:00 a.m. ET \u2013<\/i><\/p>\n<p>BOSTON&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.vrtx.com%2F&amp;esheet=54169205&amp;newsitemid=20241218007731&amp;lan=en-US&amp;anchor=Vertex+Pharmaceuticals+Incorporated&amp;index=1&amp;md5=aafef49ccfe23b888d29f56122077410\">Vertex Pharmaceuticals Incorporated<\/a> (Nasdaq: VRTX) today announced results from its Phase 2 study of suzetrigine, an investigational, oral, highly selective NaV1.8 pain signal inhibitor in people with painful lumbosacral radiculopathy (LSR). The study met its primary endpoint with statistically significant and clinically meaningful reduction in pain on the numeric pain rating scale (NPRS).<\/p>\n<p><b>Efficacy Results<\/b><\/p>\n<p>\nThe study\u2019s primary endpoint was a within-group change from baseline in the weekly average of daily leg pain intensity on the NPRS at Week 12. This 11-point scale ranges from 0 (no pain) to 10 (worst pain imaginable).<\/p>\n<p>\nThe suzetrigine arm showed a statistically significant and clinically meaningful within-group reduction from baseline in pain with a mean change in NPRS at Week 12 of -2.02.<\/p>\n<p>\nThe study also included a placebo reference arm which showed a similar within-group reduction from baseline in pain with a mean change in NPRS at Week 12 of -1.98. The study was not designed nor powered for statistical comparison between suzetrigine and placebo.<\/p>\n<table cellspacing=\"0\" class=\"bwtablemarginb bwwidth80 bwblockalignc\">\n<tr>\n<td class=\"bwtopsingle bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth60\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0<\/p>\n<\/td>\n<td class=\"bwtopsingle bwsinglebottom bwrightsingle bwpadl0 bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\"><b>Suzetrigine<br \/>\n<br \/><\/b><b>N = 102<\/b><\/p>\n<\/td>\n<td class=\"bwtopsingle bwsinglebottom bwrightsingle bwpadl0 bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\"><b>Placebo<br \/>\n<br \/><\/b><b>N = 100<\/b><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth60\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\"><b>Baseline NPRS<\/b><\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl2 bwwidth60\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\"><b>Mean NPRS (SD)<\/b><\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\">\n6.33 (1.22)<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\">\n6.05 (1.07)<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth60\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\"><b>Change in NPRS from baseline at Week 12<\/b><\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n\u00a0<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n\u00a0<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl2 bwwidth60\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\"><b>LS mean<\/b><\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\"><b>-2.02<\/b><\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\"><b>-1.98<\/b><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl2 bwwidth60\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\"><b>95% CI<\/b><\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\">\n(-2.40, -1.64)<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\">\n(-2.36, -1.60)<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl2 bwwidth60\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\"><b>P value<\/b><\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\"><b>&lt;0.0001<\/b><\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\"><b>&lt;0.0001<\/b><\/p>\n<\/td>\n<\/tr>\n<\/table>\n<p>\nSecondary and other endpoints were consistent with the study\u2019s primary endpoint.<\/p>\n<p>\nVertex also conducted post-hoc analyses to further evaluate the efficacy results. These showed that there was variability in the placebo response across study sites, a recognized issue in pain trials. In the ~40% of sites that had lower placebo responses, the suzetrigine arm within-group reduction in pain was similar to the overall study and had greater separation from the placebo arm. These analyses suggest that trial design innovation may better control the placebo response and separate the treatment effect of suzetrigine from placebo in future studies, which Vertex will incorporate as it designs the pivotal program.<\/p>\n<p><b>Safety Results<\/b><\/p>\n<p>\nSuzetrigine was generally well tolerated in the study. The incidence of adverse events (AEs) was 22.9% in the suzetrigine arm and 32.4% in the placebo arm. In both treatment arms, most AEs were mild to moderate. There were no serious adverse events (SAEs) related or possibly related to suzetrigine. There were no AEs leading to treatment discontinuation in patients treated with suzetrigine.<\/p>\n<table cellspacing=\"0\" class=\"bwtablemarginb bwwidth80 bwblockalignc\">\n<tr>\n<td class=\"bwtopsingle bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth60\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0<\/p>\n<\/td>\n<td class=\"bwtopsingle bwsinglebottom bwrightsingle bwpadl0 bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\"><b>Suzetrigine<br \/>\n<br \/><\/b><b>N = 109<br \/>\n<br \/><\/b><b>n (%)<\/b><\/p>\n<\/td>\n<td class=\"bwtopsingle bwsinglebottom bwrightsingle bwpadl0 bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\"><b>Placebo<br \/>\n<br \/><\/b><b>N = 108<br \/>\n<br \/><\/b><b>n (%)<\/b><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth60\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\"><b>Subjects with any AEs<\/b><\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\"><b>25 (22.9)<\/b><\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\"><b>35 (32.4)<\/b><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\" class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0\" rowspan=\"1\">\n<p class=\"bwcellpmargin\"><b>Subjects with AEs by strongest relationship<\/b><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth60\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\">\nNot related<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n16 (14.7)<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n20 (18.5)<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth60\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\">\nUnlikely related<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n1 (0.9)<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n6 (5.6)<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth60\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\">\nPossibly related<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n6 (5.5)<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n8 (7.4)<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth60\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\">\nRelated<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n2 (1.8)<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n1 (0.9)<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\" class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0\" rowspan=\"1\">\n<p class=\"bwcellpmargin\"><b>Subjects with AEs by maximum severity<\/b><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth60\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\">\nGrade 1\/Mild<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n15 (13.8)<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n17 (15.7)<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth60\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\">\nGrade 2\/Moderate<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n10 (9.2)<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n17 (15.7)<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth60\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\">\nGrade 3\/Severe<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n0<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n1 (0.9)<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth60\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\">\nGrade 4\/Life-threatening<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n0<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n0<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth60\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\">\nGrade 5\/Death<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n0<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n0<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth60\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\"><b>Subjects with serious AEs<\/b><\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n1 (0.9)<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n2 (1.9)<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth60\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\"><b>Subjects with AEs leading to treatment discontinuation<\/b><\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n0<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n1 (0.9)<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth60\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\"><b>Subjects with AEs leading to death<\/b><\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n0<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignb bwpadb3 bwalignc bwwidth20\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n0<\/p>\n<\/td>\n<\/tr>\n<\/table>\n<p>\n\u201cSuzetrigine has again demonstrated its potential to fill an important unmet need in the treatment of pain. Today&#8217;s LSR results are consistent with previous studies of this pain signal inhibitor in terms of showing a meaningful treatment effect across pain conditions and a favorable safety profile,\u201d said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. \u201cWe did not see separation between the suzetrigine and the placebo arms. Yet our post-hoc analyses suggest that this could be due to the high placebo response in this study. We remain committed to studying LSR and innovating our Phase 3 study design to control for the placebo effect as we advance suzetrigine into pivotal development for this condition.\u201d<\/p>\n<p>\n\u201cThe suzetrigine Phase 2 results clearly show reduced pain intensity from baseline in the active drug arm, and the potential for suzetrigine to fill an unmet need in relieving LSR pain, a heterogeneous condition that is notoriously difficult to treat,\u201d said Christine Sang, M.D., M.P.H., FASA, Director, Translational Pain Research, Brigham and Women&#8217;s Hospital, Associate Professor of Anesthesia, Harvard Medical School, co-chair of Vertex\u2019s Peripheral Neuropathic Pain steering committee, and lead principal investigator on the study. \u201cManaging the placebo response in pain trials is a complex challenge. We look forward to innovating in clinical trial design, including for the pivotal study, with the aim of bringing a potentially safe and effective treatment to patients suffering from LSR.&#8221;<\/p>\n<p><b>Next Steps for the Pain Portfolio<\/b><\/p>\n<p><b>Neuropathic Pain<\/b><\/p>\n<p>\nVertex plans to advance suzetrigine into pivotal development for painful LSR following discussions with regulators on the study design and regulatory package. The company will apply learnings from analysis of the full Phase 2 data set and post-hoc analyses to inform the Phase 3 study design.<\/p>\n<p>\nEarlier this year, Vertex initiated its suzetrigine pivotal program in painful diabetic peripheral neuropathy (DPN), another type of peripheral neuropathic pain (PNP). That study is ongoing.<\/p>\n<p><b>Acute Pain<\/b><\/p>\n<p>\nAdditionally, as previously <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fnews.vrtx.com%2Fnews-releases%2Fnews-release-details%2Fvertex-announces-fda-acceptance-new-drug-application-suzetrigine&amp;esheet=54169205&amp;newsitemid=20241218007731&amp;lan=en-US&amp;anchor=announced&amp;index=2&amp;md5=9185bad32019a226619a6d79042b2bc2\">announced<\/a>, suzetrigine is under FDA review for the treatment of moderate-to-severe acute pain. The agency granted priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2025.<\/p>\n<p>\nIn line with its portfolio strategy, Vertex continues to advance preclinical and clinical development of additional NaV1.8 and NaV1.7 inhibitors, for use alone or in combination, in acute and neuropathic pain.<\/p>\n<p><b>Conference Call and Webcast<\/b><\/p>\n<p>\nThe company will host a conference call and webcast at 8:00 a.m. ET on Thursday, December 19, 2024. To access the call, please dial (833) 630-2124 (U.S.) or +1 (412) 317-0651 (International) and reference the \u201cVertex Pharmaceuticals Conference Call.\u201d<\/p>\n<p>\nThe conference call will be webcast live and a link to the webcast can be accessed through Vertex&#8217;s website at <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.vrtx.com%2F&amp;esheet=54169205&amp;newsitemid=20241218007731&amp;lan=en-US&amp;anchor=www.vrtx.com&amp;index=3&amp;md5=0eb0871ff99207b49bc1668b8169c4b6\">www.vrtx.com<\/a> in the &#8220;Investors&#8221; section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company&#8217;s website.<\/p>\n<p><b>About the Phase 2 Suzetrigine Lumbosacral Radiculopathy (LSR) Study<\/b><\/p>\n<p>\nThis phase 2, 12-week, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of suzetrigine in treating patients with painful LSR. A total of 218 patients were enrolled in the study and randomized 1:1 with suzetrigine or placebo. The primary endpoint was the within-group change from baseline in the weekly average of daily leg pain intensity on a numeric pain rating scale (NPRS) at Week 12. The study also included a placebo reference arm; however, the study was not designed nor powered for comparison between suzetrigine and placebo.<\/p>\n<p>\nSecondary endpoints assessed the within-group change from baseline in the weekly average of the daily sleep interference scale at Week 12 and safety and tolerability. By blocking the pain signal from the peripheral sensory neurons, Vertex believes that suzetrigine may alleviate the suffering for millions of patients with painful LSR.<\/p>\n<p><b>About Painful Lumbosacral Radiculopathy (LSR)<\/b><\/p>\n<p>\nPainful lumbosacral radiculopathy, or LSR, is one of the most common causes of peripheral neuropathic pain. It is pain caused by impairment of nerve roots in the area of the lumbar spine. It often results in radiating pain along the distribution of the impacted nerve in the body, and patients can experience back and leg pain, sensory issues or motor dysfunction. Common causes of LSR include nerve compression from a herniated disk, or arthritic or degenerative changes in the area of the lower spine. LSR is a neuropathic pain condition because the impacted nerve roots are part of the peripheral nervous system and not part of the spinal cord. Millions of patients suffer from pain due to LSR every year.<\/p>\n<p><b>About Suzetrigine<\/b><\/p>\n<p>\nSuzetrigine is an investigational oral, highly selective pain signal inhibitor that is selective for NaV1.8 relative to other NaV channels. NaV1.8 is a voltage-gated sodium channel that is selectively expressed in peripheral pain-sensing neurons (nociceptors), where its role is to transmit pain signals (action potentials). Vertex\u2019s approach is to selectively inhibit NaV1.8 using small molecules with the objective of creating a new class of pain signal inhibitors that have the potential to provide effective relief of pain without the limitations of currently available therapies, including the addictive potential of opioids. Suzetrigine has demonstrated a favorable benefit\/risk profile in multiple Phase 2 and Phase 3 studies in patients with moderate-to-severe acute pain and has been granted FDA Fast Track and Breakthrough Therapy designations in moderate-to-severe acute pain in the U.S. It is currently under priority review by the FDA for the treatment of moderate-to-severe acute pain with a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2025. The Phase 3 pivotal program for suzetrigine in patients with painful diabetic peripheral neuropathy is ongoing, and the company plans to advance its pivotal program evaluating suzetrigine in patients with painful lumbosacral radiculopathy pending discussions with regulators. Suzetrigine is investigational and has not been approved by any health authority.<\/p>\n<p><b>About Vertex<\/b><\/p>\n<p>\nVertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases \u2014 cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia \u2014 and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1.<\/p>\n<p>\nVertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry&#8217;s top places to work, including 15 consecutive years on Science magazine&#8217;s Top Employers list and one of Fortune\u2019s 100 Best Companies to Work For. For company updates and to learn more about Vertex&#8217;s history of innovation, visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.vrtx.com%2F&amp;esheet=54169205&amp;newsitemid=20241218007731&amp;lan=en-US&amp;anchor=www.vrtx.com&amp;index=4&amp;md5=8c20cce5049424a754be5c3356bb9bc9\">www.vrtx.com<\/a> or follow us on <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fvertex-pharmaceuticals&amp;esheet=54169205&amp;newsitemid=20241218007731&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=5&amp;md5=fcc5759c451adee06ba4bff8c7aaae70\">LinkedIn<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.facebook.com%2FVertexPharmaInc&amp;esheet=54169205&amp;newsitemid=20241218007731&amp;lan=en-US&amp;anchor=Facebook&amp;index=6&amp;md5=ba9981a89d141d68d0ebd6808e98f2f9\">Facebook<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.instagram.com%2Fvertexpharmaceuticals%2F&amp;esheet=54169205&amp;newsitemid=20241218007731&amp;lan=en-US&amp;anchor=Instagram&amp;index=7&amp;md5=5cd3cd2c9156c01a0b3f6b6e3bc1e6dc\">Instagram<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.youtube.com%2F%40VertexPharmaceuticalsGlobal&amp;esheet=54169205&amp;newsitemid=20241218007731&amp;lan=en-US&amp;anchor=YouTube&amp;index=8&amp;md5=98150e38c7efa299f18e37980f226f1f\">YouTube<\/a> and <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fx.com%2FVertexPharma&amp;esheet=54169205&amp;newsitemid=20241218007731&amp;lan=en-US&amp;anchor=X&amp;index=9&amp;md5=94f5a89bc4c5f93b6e41634f9fec5d9c\">X<\/a>.<\/p>\n<p><b>Special Note Regarding Forward-Looking Statements<\/b><\/p>\n<p>\nThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements by Carmen Bozic, M.D., and Christine Sang, M.D., M.P.H., FASA, in this press release, and statements regarding Vertex\u2019s beliefs about the potential benefits of suzetrigine for patients with LSR, plans to advance suzetrigine to Phase 3 pending discussions with regulators, plans and expectations for the design of the pivotal program, plans to apply learnings from the Phase 2 data and post-hoc analyses to inform the Phase 3 study design, including beliefs that trial design innovation may better control the placebo response and separate the treatment effect of suzetrigine from placebo in future studies,<b \/>and our plans to continue to advance preclinical and clinical development of additional NaV1.8 and NaV1.7 inhibitors in acute and neuropathic pain. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company&#8217;s beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the clinical program evaluating suzetrigine as a treatment for LSR may not support registration or further development of its compounds due to safety, efficacy or other reasons, that discussions with regulators may have different outcomes than the company anticipates, and other risks listed under the heading \u201cRisk Factors\u201d in Vertex&#8217;s most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission at <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.sec.gov%2F&amp;esheet=54169205&amp;newsitemid=20241218007731&amp;lan=en-US&amp;anchor=www.sec.gov&amp;index=10&amp;md5=8a135e5871461db3836afd520ef7cee5\">www.sec.gov<\/a> and available through the company&#8217;s website at <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.vrtx.com%2F&amp;esheet=54169205&amp;newsitemid=20241218007731&amp;lan=en-US&amp;anchor=www.vrtx.com&amp;index=11&amp;md5=2c24a88bb1fe8c73f0f512c81f39763a\">www.vrtx.com<\/a>. You should not place undue reliance on these statements, or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.<\/p>\n<p>\n(VRTX-GEN)<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20241218007731r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20241218007731\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20241218007731\/en\/<\/a><\/span><\/p>\n<p><b>Vertex Pharmaceuticals Incorporated<br \/>\n<\/b><br \/><b>Investors:<br \/>\n<\/b><br \/><a rel=\"nofollow\" href=\"mailto:InvestorInfo@vrtx.com\">InvestorInfo@vrtx.com<br \/>\n<\/a><br \/>Susie Lisa, CFA: +1 617-341-6108<br \/>\n<br \/>or<br \/>\n<br \/>Miroslava Minkova: +1 617-341-6135<br \/>\n<br \/><b>Media:<br \/>\n<\/b><br \/><a rel=\"nofollow\" href=\"mailto:mediainfo@vrtx.com\">mediainfo@vrtx.com<br \/>\n<\/a><br \/>or<br \/>\n<br \/>International: +44 20 3204 5275<br \/>\n<br \/>or<br \/>\n<br \/>U.S.: 617-341-6992<br \/>\n<br \/>or<br \/>\n<br \/>Heather Nichols: +1 617-839-3607<\/p>\n<p><b>KEYWORDS:<\/b> Massachusetts United States North America<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Biotechnology Health Pharmaceutical Clinical Trials Oncology<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20241218007731\/en\/1093022\/3\/Vertex_Logo_colorRGB.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Vertex Announces Results From Phase 2 Study of Suzetrigine for the Treatment of Painful Lumbosacral Radiculopathy \u2013 Treatment with the highly selective NaV1.8 pain signal inhibitor suzetrigine met the primary endpoint with a statistically significant and clinically meaningful 2.02 point within-group reduction from baseline in the Numeric Pain Rating Scale (NPRS) \u2013 \u2013 Placebo arm showed similar within-group reduction in NPRS \u2013 \u2013 Suzetrigine was generally well tolerated \u2013 \u2013 Advancement to Phase 3 inpainful lumbosacral radiculopathy planned, pending discussions with regulators \u2013 \u2013 Vertex to host investor call on December 19 at 8:00 a.m. ET \u2013 BOSTON&#8211;(BUSINESS WIRE)&#8211;Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results from its Phase 2 study of suzetrigine, an investigational, oral, highly selective NaV1.8 pain &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/vertex-announces-results-from-phase-2-study-of-suzetrigine-for-the-treatment-of-painful-lumbosacral-radiculopathy\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Vertex Announces Results From Phase 2 Study of Suzetrigine for the Treatment of Painful Lumbosacral Radiculopathy&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-796012","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Vertex Announces Results From Phase 2 Study of Suzetrigine for the Treatment of Painful Lumbosacral Radiculopathy - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/vertex-announces-results-from-phase-2-study-of-suzetrigine-for-the-treatment-of-painful-lumbosacral-radiculopathy\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Vertex Announces Results From Phase 2 Study of Suzetrigine for the Treatment of Painful Lumbosacral Radiculopathy - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Vertex Announces Results From Phase 2 Study of Suzetrigine for the Treatment of Painful Lumbosacral Radiculopathy \u2013 Treatment with the highly selective NaV1.8 pain signal inhibitor suzetrigine met the primary endpoint with a statistically significant and clinically meaningful 2.02 point within-group reduction from baseline in the Numeric Pain Rating Scale (NPRS) \u2013 \u2013 Placebo arm showed similar within-group reduction in NPRS \u2013 \u2013 Suzetrigine was generally well tolerated \u2013 \u2013 Advancement to Phase 3 inpainful lumbosacral radiculopathy planned, pending discussions with regulators \u2013 \u2013 Vertex to host investor call on December 19 at 8:00 a.m. ET \u2013 BOSTON&#8211;(BUSINESS WIRE)&#8211;Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results from its Phase 2 study of suzetrigine, an investigational, oral, highly selective NaV1.8 pain &hellip; Continue reading &quot;Vertex Announces Results From Phase 2 Study of Suzetrigine for the Treatment of Painful Lumbosacral Radiculopathy&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/vertex-announces-results-from-phase-2-study-of-suzetrigine-for-the-treatment-of-painful-lumbosacral-radiculopathy\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2024-12-19T11:03:27+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20241218007731r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"10 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/vertex-announces-results-from-phase-2-study-of-suzetrigine-for-the-treatment-of-painful-lumbosacral-radiculopathy\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/vertex-announces-results-from-phase-2-study-of-suzetrigine-for-the-treatment-of-painful-lumbosacral-radiculopathy\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Vertex Announces Results From Phase 2 Study of Suzetrigine for the Treatment of Painful Lumbosacral Radiculopathy\",\"datePublished\":\"2024-12-19T11:03:27+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/vertex-announces-results-from-phase-2-study-of-suzetrigine-for-the-treatment-of-painful-lumbosacral-radiculopathy\\\/\"},\"wordCount\":2067,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/vertex-announces-results-from-phase-2-study-of-suzetrigine-for-the-treatment-of-painful-lumbosacral-radiculopathy\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20241218007731r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/vertex-announces-results-from-phase-2-study-of-suzetrigine-for-the-treatment-of-painful-lumbosacral-radiculopathy\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/vertex-announces-results-from-phase-2-study-of-suzetrigine-for-the-treatment-of-painful-lumbosacral-radiculopathy\\\/\",\"name\":\"Vertex Announces Results From Phase 2 Study of Suzetrigine for the Treatment of Painful Lumbosacral Radiculopathy - 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