President Trump signed an executive order aimed at accelerating research and access to psychedelic-assisted treatments, a move that immediately boosted biotech stock prices and sparked both optimism and concern within the psychiatric field. Compass Pathways shares rose 25 percent in premarket trading following the announcement. The order instructs the FDA to grant Commissioner’s National Priority Vouchers (CNPVs) to “appropriate psychedelic drugs,” accelerating review times from 10-12 months to 1-2 months. Three of these vouchers will be issued this week.
Compass Pathways, which is nearing a regulatory application for psilocybin-based COMP360 for post-traumatic stress disorder, is widely expected to be among recipients. Definium Therapeutics, developing an LSD-based therapy (DT120) for anxiety and depression that already holds Breakthrough Therapy designation, could also receive a voucher. By 2027, analysts predict both COMP360 and DT120 could be approved.
However, some experts raise concerns about politicization of the process. Holly Fernandez Lynch, associate professor of Medical Ethics and Law at the University of Pennsylvania, called it “a pretty egregious step for the White House to direct FDA with regard to specific products,” noting that such politicization risks undermining the credibility of research that benefits from accelerated approval.
FDA Commissioner Marty Makary emphasized real-world evidence during the signing, stating that while “we don’t know exactly how [some medications] work, we see profound results,” but immediately affirmed that “randomized trials are needed” to support recommendations. Makary also announced the first Investigational New Drug (IND) clearance for ibogaine, which was revealed later to be DemeRX’s DMX-1001, an oral derivative called noribogaine intended for alcohol use disorder.
Ibogaine faces known safety concerns: it carries risks of cardiac toxicity and has been associated with a 48-hour or longer “waking nightmare” involving deep introspection and unavoidable memories. One 2017 study found that more than 80 percent of subjects saw withdrawal symptoms “eliminated or drastically reduced” with ibogaine treatment; Rogan cited data suggesting over 80 percent of people are free from addiction after one dose, rising to more than 90 percent with two doses. However, podcaster Joe Rogan’s account that he texted Trump about ibogaine approval drew criticism from Fernandez Lynch, who warned: “What Trump was saying around the executive order during the press conference was kind of mind blowing. Like this idea that his buddies could just send him a text and he’ll offer them FDA approval is not acceptable.”
Fernandez Lynch worries the executive order could have the opposite effect of its stated intention, creating perception that psychedelic approvals were driven by politics rather than merit. The order also addresses expedited rescheduling, funding through the Advanced Research Projects Agency for Health, and access through the Right to Try Act.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.biospace.com/drug-development/trumps-psychedelics-push-a-mixed-blessing-for-neuropsychiatric-companies-patients