On Monday, Martin Makary, director of the FDA ( Food and Drug Administration) told NBC News that, with the priority voucher program, the agency could approve the first psychedelic drug by the end of this summer 2026.
VOUCHERS HAVE BEEN ISSUED TODAY FOR THE 3 COMPANIES WHOSE PSYCHEDELIC DRUGS WILL BE THE FIRST TO BE APPROVED: PSILOCYBIN WILL BE THE FIRST PSYCHEDELIC TO BE APPROVED AND IT WILL BE DECISIVE WHETHER IT IS FIRST APPROVED THROUGH THE NON-PROFIT NGO USONA OR THROUGH THE FOR-PROFIT COMPASS. IF IT IS THROUGH USONA THE PRICE WILL BE LOWER. ON THE OTHER HAND AND BY SURPRISE THE OTHER APPROVED PSYCHEDELIC WILL BE THE METHYLONE OF THE MDMA FAMILY BUT NOT AS EFFECTIVE AND THAT HAS LESS ADVANCED CLINICAL TRIALS THAN THE ONES PRESENTED BY MAPS. WHAT WILL HAPPEN?FDA grants priority review vouchers to Otsuka, Compass and Usona.Today, the FDA announced that it has issued three Commissioner's National Priority Vouchers (CNPVs) to three psychedelic programs, fulfilling a key element of the executive order President Trump signed Saturday morning. There, FDA Commissioner Marty Makary explained that the agency would award the vouchers, which are intended to reduce the review time for new drug applications (NDAs) to just one to two months, to psychedelic drug candidates that have received Breakthrough Therapy designation and meet the other program criteria. It also indicated that three vouchers would be awarded immediately. This morning we learned that those vouchers have been awarded to the following programs:Compass Pathways psilocybin (COMP360) for treatment resistant depression (TRD)Usona Institute psilocybin for major depressive disorder (MDD)Otsuka methylone (TSND-201) for PTSDWe at Psychedelic Alpha are not surprised by the two vouchers for psilocybin, as we had publicly predicted them. However, we are surprised that the agency would go with Otsuka's methylone program rather than Resilient Pharmaceuticals« MDMA for PTSD program, which we had expected to receive a voucher. Here we provide more details on each program, as well as the potential implications of the vouchers, which are part of a program established by the agency last summer.Compass» Psilocybin for Resilient Depression:This will come as no surprise, given that Compass recently shared preliminary data from its second Phase 3 study and has indicated that it intends to submit its New Drug Approval (NDA) application in the fourth quarter.It should be recalled, however, that Compass was on a draft CNPV award list last October, but was vetoed by the White House at the last minute, apparently due to concerns about how the move would be viewed by the president's supporters. The FDA awarded the program Breakthrough Therapy designation in late 2018. Usona Institute's Psilocybin for Major Depressive Disorder:The nonprofit Usona Institute, a psychedelic drug development organization, has also received a nonprofit drug voucher (CNPV), FDA announced today. This voucher covers its psilocybin program for major depressive disorder (MDD), which received Breakthrough Therapy designation from the agency in 2019. As we have previously reported, we anticipate that Usona will submit its New Drug Approval (NDA) application based on its single Phase 3 study. In light of this, the application could be submitted on a similar timeline as Compass, much sooner than many assumed. As we wrote last December , this would raise many questions. The main one, at least for investors, revolves around the extent to which Compass would be able to prevent its nonprofit competitor from entering the market, should the for-profit company be the first to get approval. If Usona were to get around Compass's tangle of psilocybin patents and any other exclusivity, we noted then, «one would expect it to have a simple strategy: relentlessly undercut COMP360»s prices.« However, the penalties for marketing a product that infringes another's intellectual property are severe, so enormous uncertainty remains. There is also a question as to whether Usona has the interest or ability to bring the drug to market, should it be approved. According to its website, the company does not appear to have a prominent commercial team and is not currently hiring staff. Of course, it could partner with another organization.Otsuka's methylone for PTSD ( post-traumatic stress disorder):The trio's surprise coupon was given to Otsuka for the methylone program (TSND-201) for PTSD it is acquiring from Transcend Therapeutics .The program is entering Phase 3, making it the least mature of the three.MDMA-assisted psychotherapy for PTSD from Resilient (formerly Lykos-formerly MAPS Benefits):We expected the third voucher to go to Resilient Pharmaceuticals (formerly Lykos Therapeutics ), both from comments heard in the industry and from signals coming from the administration.The FDA issued a Complete Response Letter (CRL) for that program in August 2024, rejecting approval of the drug, and the contents of that CRL became public in September 2025, following a decision by the new FDA leadership to release 89 previously unpublished CRLs issued since 2024.That letter detailed at least three issues that it said »precluded approval,« including the failure to collect data on »positive« adverse effects, the absence of durability data, and high rates of prior MDMA use among study participants.In the full response letter (CRL), the agency recommended that Resilient, and subsequently Lykos, conduct a new clinical trial to address these deficiencies. It also recommended that the company consider an independent third-party audit of all study records and reports, including recordings of dosing sessions.While that review has already begun, Phase 3 has not yet been initiated.Earlier this week, Makary told the press that Resilient »has conducted an audit,» adding, "If that company submits the results of its audit of the protocol violation that was cited in the rejection about two years ago, before I headed the FDA, then it will be taken into account in due process."Those comments further reinforced our view that the agency's current leadership does not expect a new Phase 3 from the company.While we are surprised that the FDA rejected Resilient today, our view remains that the company intends to resubmit its new drug approval application without an additional Phase 3 study.Qα: The two psilocybin vouchers are no surprise and are in line with our previous reports and comments made by Makary on Saturday morning during the signing of the executive order.However, the voucher for Otsuka's methylone will be a real surprise to many. Incidentally, we had anticipated that it would be Resilient's MDMA program that would receive the voucher.In concrete terms, the issuance of these vouchers can be expected to reduce the time between the submission of a New Drug Application (NDA) and the FDA's decision. This process typically takes ten to twelve months, but the agency claims that the receipt of a discount voucher (CNPV) should reduce this to as little as one to two months. This could be a few months' improvement over the baseline scenario for psychedelic drugs with Breakthrough Therapy designation, and perhaps a slightly smaller reduction for those, such as Compass, that appear to benefit from ongoing review.The first new molecular entity to receive approval through the CNPV program was Eli Lilly's Foundayo (orforglipron), a daily weight management pill, earlier this month. That product was approved just fifty days after submission of the application for approval, providing a glimpse of how quickly a CNPV-assisted review can be.However, the CNPV program is not without controversy, as we have already reported, as some see it as conducive to corruption and political favoritism. The latter criticism is increasingly prevalent in the psychedelic arena in general, especially in the wake of Saturday's executive order and related signing ceremony.In any case, today's announcement demonstrates a sea change on the part of the White House, which just six months ago attempted to prevent the issuance of a single CNPV to Compass."
Sources:
Breaking: FDA Awards Priority Review Vouchers to Otsuka, Compass, and Usona
https://www.telemundo.com/noticias/noticias-telemundo/salud/fda-concede-revision-acelerada-ensayos-clinicos-psicodelicos-farmacos-rcna341905
