The FDA is awarding national priority vouchers to Compass Pathways, Transcend Therapeutics and the Usona Institute as the Trump administration looks for ways to support advances in psychedelic medicine. A third recipient in this batch is Transcend Therapeutics, which is being acquired by Otsuka, according to reports.
Just days after President Donald Trump’s executive order focused on accelerating access to mental health treatments, the FDA has announced a series of regulatory actions, including the issuance of three national priority vouchers to companies studying psychedelic treatments for mental health disorders.
The vouchers are meant to accelerate research, approval, and access to these treatments, according to an April 24 release from the FDA. Psychedelic medicines, used responsibly, boast therapeutic potential in areas such as treatment-resistant depression, alcoholism, major depressive disorder and post-traumatic stress disorder, FDA commissioner Marty Makary, M.D., said in the release.
In this batch of Commissioner’s National Priority Vouchers (CNPVs), the agency is placing a spotlight on psilocybin as a potential answer for treatment-resistant depression (TRD) and major depressive disorder (MDD), as well as methylone for post-traumatic stress disorder (PTSD).
Companies included in the voucher program are entitled to benefits such as improved communication with the FDA and a shorter 1- to 2-month reviews after filing an application for approval.
In a release earlier today, London-based Compass Pathways announced that the FDA granted it a rolling review request and selected COMP360, the company’s proprietary formulation of synthetic psilocybin, for the program for TRD.
In a phase 3 trial that included more than 1,000 participants, Compass says that patients with TRD experienced effects within a day of treatment that lasted at least six months for those who achieved a clinically meaningful response. In a statement, Compass CEO Kabir Nath called the voucher “a clear validation of both the urgent unmet need facing millions of people living with treatment resistant depression and the innovative science of COMP360.”
Nonprofit Usona Institute confirmed to Fierce Biotech that it has also been awarded a CNPV by the FDA for its psilocybin treatment for patients with major depressive disorder. Usona’s psilocybin program previously received an FDA breakthrough designation in 2019. Its psilocybin treatment, PSIL201, is now in phase 3.
Transcend Therapeutics confirmed with Fierce Biotech that it was third voucher recipient. It had previously received a breakthrough designation for its methylone PTSD treatment, TSND-201. The candidate met its primary endpoint in a phase 2 study last July that showed significant improvement for patients on the Clinician-Administered PTSD Scale.
In addition to the vouchers, the FDA is also allowing an early-phase clinical study of noribogaine hydrochloride to move forward following an Investigational New Drug submission by DemeRx NB. Noribogaine hydrochloride is the principal psychoactive metabolite of the oneirogen ibogaine, which is derived from an African shrub. It will be the first time the FDA has allowed a clinical study in the U.S. of a derivative of ibogaine.
The FDA follows the state of Texas’ announcement last month that it would be conducting a $50 million state-sponsored study of ibogaine after it couldn’t find a biopharma company to help run the study.
FDA Commissioner Marty Makary, M.D., said the regulatory changes are aimed at addressing the nation’s mental health crisis.
“As this field moves forward, it is critical that their development is grounded in sound science and rigorous clinical evidence. We owe it to our nation’s veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency,” he said in a statement.
