US President Donald Trump has signed an executive order focused on accelerating the route of psychedelics to the market, adding momentum to a field garnering growing pharma and public interest.
Through the order, Trump is directing the US Food and Drug Administration’s (FDA) commissioner, Marty Makary, to award expedited regulatory timelines to psychedelics that have already received breakthrough therapy designation or have completed a Phase III trial.
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This will specifically be managed through the Commissioner’s National Priority Voucher (CNPV) scheme, which has caused a stir within the industry due to the “unclear” nature of how and why vouchers are provided.
Trump’s directive also places a key focus on psychedelic research, meaning the FDA will work in tandem with the Department of Health & Human Services (HHS) to boost psychedelic clinical trial participation, while allocating $50m to fund further research into the drug class.
Alongside these research and regulatory efforts, the order aims to boost the availability of investigational drugs, namely ibogaine compounds, to eligible patients who haven’t responded to existing treatment options through the Right to Try Act. To enforce this, the FDA will work in tandem with the Drug Enforcement Administration (DEA) to create a suitable access pathway.
Plugging gaps in mental health care
Trump’s executive order comes as over 14 million adults live with a serious mental illness in the US.
Despite the burden of these diseases on the population, conditions like treatment-resistant depression (TRD) and post-traumatic stress disorder remain challenging to treat, with few treatment options available to patients.
According to Compass Pathways – developer of COMP360, an investigational psilocybin based therapy for TRD – psychedelic medicines could help bridge the gap, with the company’s CEO, Kabir Nath, noting that the order marks an “important step forward in accelerating access, without compromising science.”
Since COMP360’s double Phase III win, Compass is working on a rolling submission with the FDA for the drug in TRD. If US regulators approve COMP360, it could become the first classic psychedelic to secure the regulatory greenlight for any mental health indication.
AtaiBeckley is also eyeing the TRD market with its mebufotenin benzoate nasal spray, which is progressing to pivotal trials after triggering a 13.7-point reduction in depression scores from baseline after 12 weeks at the Phase II stage.
Dr Hans Eriksson, CMO of HMNC Brain Health, previously told Clinical Trials Arena that psychedelic medicines show great promise in the realm of psychiatry – potentially offering patients treatment durability not previously observed with traditional therapies on the market.
Psychedelic researchers are also touting the potential of these drugs in inflammatory and headache disorders, suggesting their therapeutic reach and market potential could be broad.
