The Food and Drug Administration (FDA) is taking the next step in its historic review of MDMA-assisted therapy for the treatment of post-traumatic stress disorder (PTSD), scheduling a meeting next month where an expert committee will examine the evidence behind the application.<\/p>\n
Lykos Therapeutics (formerly MAPS Public Benefit Corporation) announced on Monday that FDA\u2019s Psychopharmacologic Drugs Advisory Committee will meet on June 4 to review the results of its clinical trials for the psychedelic-assisted therapy.<\/p>\n
Not only will this be the first time in 25 years since FDA has reviewed a new PTSD treatment option, it\u2019s the first time in history that the agency has taken up a new drug application for a psychedelic substance.<\/p>\n
Amy Emerson, CEO of Lykos Therapeutics, said it is a \u201csignificant milestone in the field of psychedelic medicine, resulting from decades of clinical research and advocacy.\u201d<\/p>\n
\u201cWe look forward to the opportunity to discuss the comprehensive data package of investigational MDMA and how, if approved, it may be used as a prescription treatment in combination with psychological intervention in adults with PTSD,\u201d she said<\/a>.<\/p>\n FDA\u2019s expert panel will look at an extensive body of research that includes two randomized, double-blind, placebo-controlled Phase 3 studies<\/a> that looked at the safety and efficacy of MDMA-assisted therapy.<\/p>\n Today, we announced the first FDA Advisory Committee meeting for #PTSD<\/a> in 25 years will be held on Tuesday June 4 to review our investigational therapy. Read more on this milestone here: https:\/\/t.co\/v6LNsSB8R6<\/a> pic.twitter.com\/D2ZCMThjKz<\/a><\/p>\n \u2014 Lykos Therapeutics (@Lykos_PBC) May 6, 2024<\/a><\/p>\n<\/blockquote>\n\n The committee review will take place about four months after FDA accepted the MDMA new drug application and granted it a priority status<\/a>.<\/p>\n If the NDA is ultimately approved, the Drug Enforcement Administration (DEA) would then need to reschedule MDMA accordingly. It would become the first psychedelic in history to be approved as a pharmaceutical, to be administered in tandem with talk therapy and other supportive services.<\/p>\n FDA in 2017 designated MDMA as a \u201cbreakthrough therapy\u201d based on\u00a0previous MAPS-sponsored trials. In total, the organization says findings from 18 of its Phase 2 and Phase 3 trials formed the basis of the NDA submitted to FDA.<\/p>\n Last year, FDA released first-of-its-kind draft guidance on\u00a0the \u201cunique\u201d considerations that researchers should take into account when studying psychedelics<\/a>, which the agency says show \u201cinitial promise\u201d as potential therapies.<\/p>\n Shortly after the MDMA capsule NDA was submitted to FDA, new standards from the American Medical Association (AMA) took effect in January that\u00a0assign psychedelics-specific codes to collect data on the novel therapies<\/a>.<\/p>\n Meanwhile, a separate study by researchers at New York University\u2019s Langone Center for Psychedelic Medicine and the Centre for Psychedelic Research at Imperial College London recently found that\u00a0pairing MDMA with either psilocybin or LSD helped people overcome the \u201cchallenging experiences\u201d<\/a>\u00a0associated with use of psilocybin or LSD alone.<\/p>\n In 2022, the Biden administration\u00a0said it was \u201cactively exploring\u201d the possibility<\/a>\u00a0of creating a federal task force to investigate the therapeutic potential of psilocybin, MDMA and others ahead of the anticipated approval of the substances for prescription use.<\/p>\n Bipartisan congressional lawmakers asked the U.S. Department of Veterans Affairs (VA) last month to produce a plan to begin providing MDMA-assisted therapy for veterans<\/a> as soon as the psychedelic is approved by FDA.<\/p>\n Also, proposed changes to federal workforce drug testing guidelines<\/a> that are currently being reviewed by officials would remove screening for MDMA\u2014which has only rarely appeared in workers\u2019 urine samples during recent years\u2014and add testing for fentanyl, a substance that\u2019s become far more widespread in unregulated drug markets over the past decade.<\/p>\n DEA Head Tells Lawmakers It Would Be \u2018Inappropriate\u2019 To Comment On Marijuana Rescheduling Proposal Due To \u2018Ongoing\u2019 Administrative Process<\/a><\/p>\n<\/blockquote>\n\n Photo courtesy of Pretty Drugthings<\/a> on Unsplash.<\/em><\/p>\n The post FDA Expert Committee Will Review MDMA-Assisted Therapy For PTSD Next Month<\/a> appeared first on Marijuana Moment<\/a>.<\/p>\n
The Food and Drug Administration (FDA) is taking the next step in its historic review of MDMA-assisted therapy for the treatment of post-traumatic stress disorder (PTSD), scheduling a meeting next month where an expert committee will examine the evidence behind the application. Lykos Therapeutics (formerly MAPS Public Benefit Corporation) announcedContinue Reading<\/a><\/span><\/p>\n","protected":false},"author":458,"featured_media":0,"comment_status":"false","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[18,81],"tags":[],"_links":{"self":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/75047"}],"collection":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/users\/458"}],"replies":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/comments?post=75047"}],"version-history":[{"count":1,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/75047\/revisions"}],"predecessor-version":[{"id":75048,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/75047\/revisions\/75048"}],"wp:attachment":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media?parent=75047"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/categories?post=75047"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/tags?post=75047"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n
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\nRead More: FDA Expert Committee Will Review MDMA-Assisted Therapy For PTSD Next Month<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"