FDA grants three priority vouchers to psychedelics

 Following up on President Donald Trump's April 18th executive order, the US FDA has issued three more Commissioner's National Priority Vouchers, all to companies working on psychedelics.

The announcement from FDA, which dropped Friday afternoon, doesn't name the three recipients, but Endpoints has identified them as Compass Pathways, Transcend Therapeutics (currently being acquired by Otsuka Therapeutics) and the Usona Institute. At press time, only Compass Pathways has confirmed its participation, issuing a press release. All three companies have previously received Breakthrough Therapy Designations from the agency.

“Under President Trump’s leadership, we are accelerating the research, approval, and responsible access to promising mental health treatments—including psychedelic therapies like ibogaine—to confront our nation’s mental health crisis head-on, especially for our veterans,” HHS Secretary Robert F. Kennedy, Jr. said in a statement. “The FDA will prioritise therapies with Breakthrough Therapy designation, where early evidence shows meaningful improvement over existing options for serious mental illness.”

Compass Pathways, which is in the midst of two ongoing Phase 3 trials of its synthetic psilocybin COMP360, is perhaps the least surprising recipient, as it's widely considered to be the closest psychedelics company to market. 

“We are honoured and grateful to be selected for the CNPV which is a clear validation of both the urgent unmet need facing millions of people living with treatment resistant depression and the innovative science of COMP360,” Kabir Nath, CEO of Compass Pathways, said in a statement. “As the most advanced company in the classic psychedelics field, Compass has generated positive data from two large, well controlled Phase 3 clinical trials. Based on the strength of our data, the FDA granted us a rolling NDA submission and review. Importantly, while the CNPV may provide process efficiencies and accelerated review timelines, an NDA submission must still meet FDA’s established standards of clinical evidence, scientific rigour, and regulatory compliance. We are confident we meet these standards.”

When pharmaphorum spoke with Compass Pathways Chief Patient Officer Steve Levine for a recent feature, he mentioned the company's longstanding positive relationship with the agency.

"Some of the turnover in FDA leadership and other changes within FDA notwithstanding, the psychiatry division, which is the division that we work with, has remained intact over the years," he said. "The people we meet with today are the same people we were meeting with a few years ago. We have a very good relationship with the psychiatry division. They've been very responsive, very supportive. So again, whatever other noise or chaos there may be out there, we feel very good about the relationship that we have with the psychiatry division."

Levine said the company will have its Phase 3 data in by early Q3 and could begin a commercial launch as early as the end of the year.

Transcend Therapeutics just recently announced an acquisition by Otsuka Therapeutics centred on the company's methylone-based drug candidate for post-traumatic stress disorder (PTSD). That candidate, TSND-201, is also the recipient of the voucher. It is currently in Phase 3 studies.

The Usona Institute, a medical research organisation based in Wisconsin, is also in the midst of a Phase 3 trial, investigating chemically synthesised psylocybin in patients with major depressive disorder, similar to Compass Pathways but without its particular focus on treatment-resistant depression.

In addition to the three NPVs, the FDA also announced the approval of an IND submission for DemeRx, which is investigating noribogaine, an ibogaine derivative, for alcohol use disorder. Ibogaine was a particular focus of the President's executive order.

https://pharmaphorum.com/news/fda-grants-three-priority-vouchers-psychedelics