{"id":535507,"date":"2021-09-08T08:05:26","date_gmt":"2021-09-08T12:05:26","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/ensysce-biosciences-announces-treatment-of-first-cohort-for-subjects-in-clinical-study-of-its-next-generation-opioid-pf614\/"},"modified":"2021-09-08T08:05:26","modified_gmt":"2021-09-08T12:05:26","slug":"ensysce-biosciences-announces-treatment-of-first-cohort-for-subjects-in-clinical-study-of-its-next-generation-opioid-pf614","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/ensysce-biosciences-announces-treatment-of-first-cohort-for-subjects-in-clinical-study-of-its-next-generation-opioid-pf614\/","title":{"rendered":"Ensysce Biosciences Announces Treatment of First Cohort for Subjects in Clinical Study of its Next Generation Opioid, PF614"},"content":{"rendered":"<h2>\nCompany Commences Second Study of Trypsin Activated Abuse Protected (TAAP) Opioid, PF614, on September 7, 2021<br \/>\n<\/h2>\n<div class=\"mw_release\">\n<p>SAN DIEGO, Sept.  08, 2021  (GLOBE NEWSWIRE) &#8212; Ensysce Biosciences, Inc. (\u201cEnsysce\u201d or the \u201cCompany\u201d) (NASDAQ: ENSC, OTC: ENSCW), a clinical-stage biotech company with proprietary technology platforms to reduce the economic and social burden of prescription drug abuse and overdose, today announced that it has enrolled the first cohort of subjects in a clinical study PF614-102 entitled \u201cA Phase 1b, Randomized, 2-Part Single-Center Study to Evaluate the Pharmacokinetics and Safety of Multiple-Ascending Oral Doses of PF614 and the Food Effect and Bioavailability\/Bioequivalence of Single Oral Doses of PF614 Relative to OxyContin in Healthy Adult Subjects.\u201d The study is being conducted by Matthew Johnston, MD, PRA Health Sciences, Salt Lake City, Utah.<\/p>\n<p>PF614 is designed as an extended-release oxycodone prodrug with <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=HuYWf8IGJ2JwGwEnWoXk9VtzyoUPo-aJbmUc_AWGpJASfh_14eAd0ypWn_mZ7-ekCtT0LdxL_aEVH0Zpg-t3RC7M31OHG5UBrCiUngFrMYoc2jOXsA36R0Y2oyMaAuQ-VKFQ6_L0TyNaNtYIn92oSw==\" rel=\"nofollow noopener\" target=\"_blank\">trypsin-activated abuse protection (TAAP)<\/a>. TAAP chemical modification inactivates the active ingredient in Ensysce\u2019s opioids products including PF614 and provides abuse deterrence, resistance to manipulation and other forms of recreational drug abuse, while providing a high degree of pain relief for those in severe pain. This study will build on the safety and pharmacokinetic results of the initial Phase 1 study, and may lead to an understanding of how PF614 compares to currently available commercial products.<\/p>\n<p>\u201cFinding a safe and effective treatment to address the opioid crisis is a pressing health priority,\u201d said Dr. William Schmidt, Chief Medical Officer of Ensysce. \u201cThis study will be an important step toward achieving our goal of developing the next generation of opioid products for patients in chronic pain.\u201d<\/p>\n<p>\u201cThis important study, to demonstrate how PF614 compares to OxyContin, may lead to the ability to use the 505(b)(2) regulatory path to registration, and the more seamless commercialization of this highly innovative approach to reduce opioid abuse.\u201d said David Kovacs, VP of Public Policy.\u00a0 \u201cI joined this team because I\u00a0believe\u00a0these products\u00a0may provide\u00a0an opportunity to change the course of this huge societal problem.\u201d\u00a0<\/p>\n<p>Dr. Lynn Kirkpatrick, CEO of Ensysce Biosciences, commented: \u201cOur mission is to transform pain treatment and provide a critical solution to the opioid crisis. We believe our approach can contribute to making opioid pain relief a more acceptable therapeutic option in the future, and we remain focused on our commitment to stem the prescription drug abuse epidemic by bringing our unique pipeline of products to the industry, which will ultimately provide safer options for both prescribers and patients.\u201d<\/p>\n<p>\n        <strong>About Ensysce Biosciences: <\/strong><br \/>\n        <br \/>Ensysce Biosciences, San Diego, CA is a clinical-stage biotech company using its proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin Activated Abuse Protection (TAAP) and Multi-Pill Abuse Resistance (MPAR\u2122) platforms, the Company is in the process of developing a new class of powerful, tamper-proof opioids that prevent both drug abuse and overdoses. Ensysce\u2019s products are anticipated to provide safer options to treat severe pain and assist in preventing deaths caused by opioid abuse, reducing the human and economic cost. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. For more information, please visit <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=4y9J-CyUxF6ojzNnlqEoM9WPFLX3umZcpB5siZCiNzr_cGDh0k1QEQXXM40HYfbFgzPFDlVjm3EOzZERFqlwDQ==\" rel=\"nofollow noopener\" target=\"_blank\">www.ensysce.com<\/a>.<\/p>\n<p>\n        <strong>Forward-Looking Statements<\/strong><br \/>\n        <br \/>Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as \u201cmay,\u201d \u201cintends,\u201d \u201ccan,\u201d \u201cmight,\u201d \u201cwill,\u201d \u201cexpect,\u201d \u201cplan,\u201d and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that the clinical programs will be successful in demonstrating safety and\/or efficacy, that Ensysce will not encounter problems or delays in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking statements are based on estimates and assumptions by Ensysce\u2019s management that, although Ensysce believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Ensysce expected. In addition, Ensysce\u2019s business is subject to additional risks and uncertainties, including among others, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce\u2019s product candidates; the availability or commercial potential of product candidates; the ability of Ensysce to fund its continued operations, including its planned clinical trials; and Ensysce\u2019s and its partners\u2019 ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of material risks and uncertainties that are described in Ensysce\u2019s most recent Form S-4 and Ensysce\u2019s definitive proxy statement\/prospectus relating to the recently completed business combination with LACQ. Any forward-looking statement speaks only as of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law.<\/p>\n<p>\n        <strong>Ensysce Biosciences Company Contact<\/strong><br \/>\n        <br \/>Lynn Kirkpatrick, Ph.D.<br \/>Chief Executive Officer <br \/>(858) 263-4196<\/p>\n<p>\n        <strong>Ensysce Biosciences <\/strong><br \/>\n        <strong>Investor Relations Contact:<\/strong><br \/>\n        <br \/>Gateway Investor Relations<br \/>Alex Thompson, Matt Glover<br \/>(949) 574-3860<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=XpJu5cPARjnDm0lJgbbxiTO7IXbFf2mxOxQXcywJwDQnEECDdzLbJz6x6Dt0unXwvpURI-rX3jWWfWY21F7M2ynHZMGkvOSkvabeBtkfMQc=\" rel=\"nofollow noopener\" target=\"_blank\">Ensysce@gatewayir.com<\/a><\/p>\n<\/p>\n<p>      <img decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODMyMTY3NyM0Mzg5NDE2IzIyMDk0NjA=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" src=\"https:\/\/ml.globenewswire.com\/media\/NGMyMTY2ZjAtYWI0NS00MTNmLThmMDQtZDc2MWFhNzVkMGU5LTEyMjEwMTM=\/tiny\/Ensysce-Biosciences-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Company Commences Second Study of Trypsin Activated Abuse Protected (TAAP) Opioid, PF614, on September 7, 2021 SAN DIEGO, Sept. 08, 2021 (GLOBE NEWSWIRE) &#8212; Ensysce Biosciences, Inc. (\u201cEnsysce\u201d or the \u201cCompany\u201d) (NASDAQ: ENSC, OTC: ENSCW), a clinical-stage biotech company with proprietary technology platforms to reduce the economic and social burden of prescription drug abuse and overdose, today announced that it has enrolled the first cohort of subjects in a clinical study PF614-102 entitled \u201cA Phase 1b, Randomized, 2-Part Single-Center Study to Evaluate the Pharmacokinetics and Safety of Multiple-Ascending Oral Doses of PF614 and the Food Effect and Bioavailability\/Bioequivalence of Single Oral Doses of PF614 Relative to OxyContin in Healthy Adult Subjects.\u201d The study is being conducted by Matthew Johnston, MD, &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/ensysce-biosciences-announces-treatment-of-first-cohort-for-subjects-in-clinical-study-of-its-next-generation-opioid-pf614\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Ensysce Biosciences Announces Treatment of First Cohort for Subjects in Clinical Study of its Next Generation Opioid, PF614&#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-535507","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Ensysce Biosciences Announces Treatment of First Cohort for Subjects in Clinical Study of its Next Generation Opioid, PF614 - 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\/ensysce-biosciences-announces-treatment-of-first-cohort-for-subjects-in-clinical-study-of-its-next-generation-opioid-pf614\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Ensysce Biosciences Announces Treatment of First Cohort for Subjects in Clinical Study of its Next Generation Opioid, PF614 - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Company Commences Second Study of Trypsin Activated Abuse Protected (TAAP) Opioid, PF614, on September 7, 2021 SAN DIEGO, Sept. 08, 2021 (GLOBE NEWSWIRE) &#8212; Ensysce Biosciences, Inc. (\u201cEnsysce\u201d or the \u201cCompany\u201d) (NASDAQ: ENSC, OTC: ENSCW), a clinical-stage biotech company with proprietary technology platforms to reduce the economic and social burden of prescription drug abuse and overdose, today announced that it has enrolled the first cohort of subjects in a clinical study PF614-102 entitled \u201cA Phase 1b, Randomized, 2-Part Single-Center Study to Evaluate the Pharmacokinetics and Safety of Multiple-Ascending Oral Doses of PF614 and the Food Effect and Bioavailability\/Bioequivalence of Single Oral Doses of PF614 Relative to OxyContin in Healthy Adult Subjects.\u201d The study is being conducted by Matthew Johnston, MD, &hellip; Continue reading &quot;Ensysce Biosciences Announces Treatment of First Cohort for Subjects in Clinical Study of its Next Generation Opioid, PF614&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/ensysce-biosciences-announces-treatment-of-first-cohort-for-subjects-in-clinical-study-of-its-next-generation-opioid-pf614\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-09-08T12:05:26+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODMyMTY3NyM0Mzg5NDE2IzIyMDk0NjA=\" \/>\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=\"4 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\\\/ensysce-biosciences-announces-treatment-of-first-cohort-for-subjects-in-clinical-study-of-its-next-generation-opioid-pf614\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ensysce-biosciences-announces-treatment-of-first-cohort-for-subjects-in-clinical-study-of-its-next-generation-opioid-pf614\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Ensysce Biosciences Announces Treatment of First Cohort for Subjects in Clinical Study of its Next Generation Opioid, PF614\",\"datePublished\":\"2021-09-08T12:05:26+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ensysce-biosciences-announces-treatment-of-first-cohort-for-subjects-in-clinical-study-of-its-next-generation-opioid-pf614\\\/\"},\"wordCount\":902,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ensysce-biosciences-announces-treatment-of-first-cohort-for-subjects-in-clinical-study-of-its-next-generation-opioid-pf614\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODMyMTY3NyM0Mzg5NDE2IzIyMDk0NjA=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ensysce-biosciences-announces-treatment-of-first-cohort-for-subjects-in-clinical-study-of-its-next-generation-opioid-pf614\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ensysce-biosciences-announces-treatment-of-first-cohort-for-subjects-in-clinical-study-of-its-next-generation-opioid-pf614\\\/\",\"name\":\"Ensysce Biosciences Announces Treatment of First Cohort for Subjects in Clinical Study of its Next Generation Opioid, PF614 - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/ensysce-biosciences-announces-treatment-of-first-cohort-for-subjects-in-clinical-study-of-its-next-generation-opioid-pf614\/","og_locale":"en_US","og_type":"article","og_title":"Ensysce Biosciences Announces Treatment of First Cohort for Subjects in Clinical Study of its Next Generation Opioid, PF614 - Market Newsdesk","og_description":"Company Commences Second Study of Trypsin Activated Abuse Protected (TAAP) Opioid, PF614, on September 7, 2021 SAN DIEGO, Sept. 08, 2021 (GLOBE NEWSWIRE) &#8212; Ensysce Biosciences, Inc. (\u201cEnsysce\u201d or the \u201cCompany\u201d) (NASDAQ: ENSC, OTC: ENSCW), a clinical-stage biotech company with proprietary technology platforms to reduce the economic and social burden of prescription drug abuse and overdose, today announced that it has enrolled the first cohort of subjects in a clinical study PF614-102 entitled \u201cA Phase 1b, Randomized, 2-Part Single-Center Study to Evaluate the Pharmacokinetics and Safety of Multiple-Ascending Oral Doses of PF614 and the Food Effect and Bioavailability\/Bioequivalence of Single Oral Doses of PF614 Relative to OxyContin in Healthy Adult Subjects.\u201d The study is being conducted by Matthew Johnston, MD, &hellip; Continue reading \"Ensysce Biosciences Announces Treatment of First Cohort for Subjects in Clinical Study of its Next Generation Opioid, PF614\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/ensysce-biosciences-announces-treatment-of-first-cohort-for-subjects-in-clinical-study-of-its-next-generation-opioid-pf614\/","og_site_name":"Market Newsdesk","article_published_time":"2021-09-08T12:05:26+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODMyMTY3NyM0Mzg5NDE2IzIyMDk0NjA=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/ensysce-biosciences-announces-treatment-of-first-cohort-for-subjects-in-clinical-study-of-its-next-generation-opioid-pf614\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/ensysce-biosciences-announces-treatment-of-first-cohort-for-subjects-in-clinical-study-of-its-next-generation-opioid-pf614\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Ensysce Biosciences Announces Treatment of First Cohort for Subjects in Clinical Study of its Next Generation Opioid, PF614","datePublished":"2021-09-08T12:05:26+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/ensysce-biosciences-announces-treatment-of-first-cohort-for-subjects-in-clinical-study-of-its-next-generation-opioid-pf614\/"},"wordCount":902,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/ensysce-biosciences-announces-treatment-of-first-cohort-for-subjects-in-clinical-study-of-its-next-generation-opioid-pf614\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODMyMTY3NyM0Mzg5NDE2IzIyMDk0NjA=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/ensysce-biosciences-announces-treatment-of-first-cohort-for-subjects-in-clinical-study-of-its-next-generation-opioid-pf614\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/ensysce-biosciences-announces-treatment-of-first-cohort-for-subjects-in-clinical-study-of-its-next-generation-opioid-pf614\/","name":"Ensysce Biosciences Announces Treatment of First Cohort for Subjects in Clinical Study of its Next Generation Opioid, PF614 - 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