{"id":49564,"date":"2020-01-21T14:10:33","date_gmt":"2020-01-21T14:10:33","guid":{"rendered":"https:\/\/merryjane.com\/mdma-just-received-early-but-limited-fda-approval\/"},"modified":"2020-01-21T14:10:33","modified_gmt":"2020-01-21T14:10:33","slug":"mdma-just-received-early-but-limited-fda-approval","status":"publish","type":"post","link":"https:\/\/merryjane.com\/news\/mdma-just-received-early-but-limited-fda-approval\/","title":{"rendered":"MDMA Just Received Early But Limited FDA Approval"},"content":{"rendered":"<p>Molly is officially medicine, but <a href=\"https:\/\/therooster.com\/blog\/legal-mdma-lsd-and-psilocybin-may-revolutionize-psychotherapy-forever-but-don%E2%80%99t-break-out-the-glowsticks-just-yet\" rel=\"nofollow noopener\" target=\"_blank\"><u>don\u2019t break out<\/u><\/a> the glow sticks just yet.<\/p>\n<p>On Friday, the Multidisciplinary Association for Psychedelic Studies (MAPS) announced that the FDA granted Expanded Access designation to <a href=\"https:\/\/merryjane.com\/culture\/what-is-mdma-and-what-does-the-drug-do-to-you\" target=\"_blank\" rel=\"noopener\"><u>MDMA<\/u><\/a>, a Schedule I drug often taken by festival goers and nightclubbers. The FDA\u2019s <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5443564\/\" rel=\"nofollow noopener\" target=\"_blank\"><u>Expanded Access<\/u><\/a> or \u201ccompassionate use\u201d program allows terminally ill patients or those with difficult-to-treat conditions to legally use experimental drugs that haven\u2019t yet received <a href=\"https:\/\/merryjane.com\/news\/mdma-is-inches-away-from-getting-fda-approval\" target=\"_blank\" rel=\"noopener\"><u>full FDA approval<\/u><\/a>.&nbsp;<\/p>\n<p>\u201cWe commend [the] FDA for recognizing the great unmet medical need of PTSD by allowing access to MDMA-assisted psychotherapy on a compassionate basis for people with treatment-resistant PTSD,\u201d said MAPS\u2019s founder, Rick Doblin, in a <a href=\"https:\/\/maps.org\/news\/media\/8008-press-release-fda-agrees-to-expanded-access-program-for-mdma-assisted-psychotherapy-for-ptsd\" rel=\"nofollow noopener\" target=\"_blank\"><u>press release<\/u><\/a>. \u201cWe are delighted to begin generating real-world evidence about this potential new treatment.\u201d<\/p>\n<p>However, patients looking to sign up for MDMA treatment will need to get in line. According to MAPS, the FDA has only approved 50 patients across 10 US clinics under the Expanded Access program. After the first 35 patients undergo MDMA-assisted psychotherapy, MAPS can potentially increase the total number of approved patients.&nbsp;<\/p>\n<p>Furthermore, only patients with \u201cmoderate to severe treatment-resistant PTSD\u201d can qualify \u2014 so that means they\u2019ll need plenty of medical documentation to back-up their treatment-resistant claims. And they\u2019ll need <a href=\"https:\/\/newatlas.com\/health-wellbeing\/mdma-psychotherapy-ptsd-expanded-access-fda-maps\/\" rel=\"nofollow noopener\" target=\"_blank\"><u>$15,000<\/u><\/a> for the treatment, too.<\/p>\n<p><iframe loading=\"lazy\" allowfullscreen=\"true\" frameborder=\"0\" width=\"640\" height=\"430\" scrolling=\"no\" src=\"https:\/\/merryjane.com\/embed\/gallery\/ecstasy-pills-that-look-like-famous-brands-and-logos\/1\" ><\/iframe><\/p>\n<p>\u201cThe resurgence of research into using drugs such as MDMA to catalyze psychotherapy is the most promising and exciting development I\u2019ve seen in my psychiatric career,\u201d <a href=\"https:\/\/maps.org\/news\/media\/8008-press-release-fda-agrees-to-expanded-access-program-for-mdma-assisted-psychotherapy-for-ptsd\" rel=\"nofollow noopener\" target=\"_blank\"><u>said<\/u><\/a> Michael Mithoefer, MD, the Acting Medical Director for MAPS\u2019s Public Benefit Corporation. \u201cCombining the powerful effects of pharmacology with the potential depth of psychotherapy is a compelling model for harnessing advances in neuroscience and psychopharmacology without ignoring the complexity, richness and innate capacity of the human psyche.\u201d<\/p>\n<p>For decades, <a href=\"https:\/\/maps.org\/research\/mdma\" rel=\"nofollow noopener\" target=\"_blank\"><u>MAPS has funded<\/u><\/a>, designed, and overseen clinical studies for MDMA as a potential treatment for PTSD. Currently, there is no cure for PTSD. Conventional treatments typically include years of talk therapies and an addictive cocktail of tranquilizers, opioids, and mood stabilizers to control its symptoms.&nbsp;<\/p>\n<p>But recent studies show that in <a href=\"https:\/\/merryjane.com\/news\/mdma-erases-ptsd-symptoms-after-two-guided-sessions-study-finds\" target=\"_blank\" rel=\"noopener\"><u>as little as two<\/u><\/a> MDMA-assisted therapy sessions, some patients no longer qualify for full-blown PTSD, which has been practically unheard of modern medicine \u2014 <a href=\"https:\/\/merryjane.com\/news\/scientists-finally-figured-out-how-ecstasy-treats-ptsd\" target=\"_blank\" rel=\"noopener\"><u>until now<\/u><\/a>. The drug\u2019s effects can possibly <a href=\"https:\/\/merryjane.com\/news\/iraq-war-vet-says-mdma-cured-his-ptsd-3-years-after-treatment\" target=\"_blank\" rel=\"noopener\"><u>last for years at a time<\/u><\/a>, as well, indicating that patients may not have to continuously undergo MDMA-assisted psychotherapy to receive its benefits.<\/p>\n<p>US researchers recently entered Phase III clinical trials for MDMA, which means the drug is in the final stages before receiving FDA approval and can hit the American market. While the Expanded Access program has so far only softly approved MDMA for treating PTSD, other studies have shown that MDMA can also potentially help with <a href=\"https:\/\/merryjane.com\/news\/mdma-assisted-psychotherapy-clinics-to-open-in-philly-next-year\" target=\"_blank\" rel=\"noopener\"><u>clinical depression<\/u><\/a>; mentally and emotionally <a href=\"https:\/\/www.theverge.com\/2015\/3\/21\/8269423\/mdma-medical-use-clinical-trial-terminally-ill\" rel=\"nofollow noopener\" target=\"_blank\"><u>coping with death<\/u><\/a>; and can facilitate deep, meaningful, <a href=\"https:\/\/www.independent.co.uk\/news\/science\/mdma-empathy-study-drug-use-ecstasy-exeter-university-a8768801.html\" rel=\"nofollow noopener\" target=\"_blank\"><u>empathic bonding<\/u><\/a> between individuals. Also, MDMA is fucking awesome for <a href=\"https:\/\/merryjane.com\/news\/swingers-love-combining-ecstasy-with-sex-study-finds\" target=\"_blank\" rel=\"noopener\"><u>chemsex<\/u><\/a> (or so we\u2019ve heard), but that application will likely never receive FDA approval.&nbsp;<\/p>\n<p>While the data suggests that MDMA is perfectly safe if administered in a controlled, infrequent manner, heavy and frequent use can cause irreversible <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/19500935\" rel=\"nofollow noopener\" target=\"_blank\"><u>skeletal-muscular damage<\/u><\/a>. Meanwhile, cannabis flower, which is relatively non-toxic, <a href=\"https:\/\/blog.norml.org\/2019\/09\/20\/why-dr-sue-sisley-sued-the-dea-for-stonewalling-cannabis-research\/\" rel=\"nofollow noopener\" target=\"_blank\"><u>still hasn\u2019t<\/u><\/a> even entered into Phase I clinical trials in the US.&nbsp;<\/p>\n<p><em>Follow Randy Robinson on <\/em><a href=\"https:\/\/twitter.com\/randieseljay\" rel=\"nofollow noopener\" target=\"_blank\"><u><em>Twitter<\/em><\/u><\/a><em>, <\/em><a href=\"https:\/\/www.instagram.com\/randieseljay\/\" rel=\"nofollow noopener\" target=\"_blank\"><u><em>Instagram<\/em><\/u><\/a><em>, and <\/em><a href=\"https:\/\/www.facebook.com\/randieseljay\" rel=\"nofollow noopener\" target=\"_blank\"><u><em>Facebook<\/em><\/u><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA granted MDMA an Expanded Access designation, meaning a small number of US clinics may now administer the drug for treatment-resistant forms of depression and PTSD.<\/p>\n","protected":false},"author":2,"featured_media":49565,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[3036],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.5 - 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