According to Beckley Psytech and atai Life Sciences, the FDA has granted Breakthrough Therapy designation to Beckley’s BPL-003 intranasal mebufotenin (5-MeO-DMT) for the treatment of treatment-resistant depression. Earlier this year, the companies announced that a Phase 2b trial of BPL-003 in patients with treatment-resistant depression had met its primary endpoint.
Beckley Psytech CEO Cosmo Feilding Mellen commented, “Receiving Breakthrough Therapy designation is a significant milestone which highlights the potential of BPL-003 to address the urgent unmet need of patients whose depression is not helped by existing therapies. We believe the Breakthrough Therapy designation supports the strength of our clinical data and, importantly, it will help to ensure the pivotal Phase 3 clinical program will be as expedited and efficient as possible, guided by the FDA.”
Atai CEO Srinivas Rao said, “We are now among a select group of mental health companies with clinical programs that have been recognized by the FDA with Breakthrough Therapy designations. BPL-003 is well-positioned for Phase 3 trials which are expected to initiate in the second quarter of 2026, subject to alignment with the FDA. This is great news for patients.”
Read the Beckley Psytech and atai Life Sciences press release
