{"id":469597,"date":"2021-04-01T08:03:49","date_gmt":"2021-04-01T12:03:49","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=469597"},"modified":"2021-04-01T08:03:49","modified_gmt":"2021-04-01T12:03:49","slug":"relmada-therapeutics-announces-initiation-of-second-pivotal-phase-3-study-of-rel-1017-as-adjunctive-treatment-for-patients-with-major-depressive-disorder","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/relmada-therapeutics-announces-initiation-of-second-pivotal-phase-3-study-of-rel-1017-as-adjunctive-treatment-for-patients-with-major-depressive-disorder\/","title":{"rendered":"Relmada Therapeutics Announces Initiation of Second Pivotal Phase 3 Study of REL-1017 as Adjunctive Treatment for Patients with Major Depressive Disorder"},"content":{"rendered":"
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Long-Term Safety Study Also Underway<\/h2>\n

Top-line Data from Both Pivotal Studies Expected in First Half of 2022<\/h2>\n

PR Newswire<\/p>\n<\/p><\/div>\n

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\n NEW YORK<\/span>, April 1, 2021<\/span> \/PRNewswire\/ — Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced the initiation of the second of the two sister pivotal Phase 3 clinical trials (RELIANCE I and RELIANCE II) for the Company’s lead product candidate, REL-1017, as an adjunctive treatment for major depressive disorder (MDD).<\/p>\n

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“We are pleased to begin enrolling patients into the second Phase 3 clinical trial of REL-1017 in MDD, a condition impacting more than 17 million individuals in the U.S., with limited safe and effective therapeutic options currently available,” said Sergio Traversa<\/span>, Relmada’s Chief Executive Officer. “The first Phase 3 trial, RELIANCE I, which was initiated in December 2020<\/span>, continues to enroll patients as planned, and additional sites are coming online.\u00a0Importantly, the pivotal Phase 3 studies in the RELIANCE program are optimized to reduce the risk of placebo effect associated with depression trials due to the two-arm design, strong focus on site selection and training as well as the multiple levels of screening to ensure accurate patient diagnosis. We continue to anticipate the availability of top-line data from RELIANCE I and RELIANCE II in the first half of 2022.”<\/p>\n

The company also confirmed that RELIANCE-OLS, the long-term, open-label safety study for REL-1017, is underway.\u00a0RELIANCE-OLS will include both patients continuing from the pivotal studies as well as de novo<\/i> patients. <\/p>\n

\n Key Aspects of the RELIANCE Clinical Studies Program for REL-1017 in MDD: <\/b>\n <\/p>\n