atai Life Sciences And Beckley Psytech Announces That FDA Has Granted Breakthrough Therapy Designation To Their BPL-003 Nasal Spray For Adults With Treatment-Resistant Depression

Author: Benzinga Newsdesk | October 16, 2025 03:13pm

• Breakthrough Therapy designation recognizes the potential of BPL-003 to deliver substantial improvement over existing therapies for patients with treatment-resistant depression
• FDA designation follows previously announced Phase 2b topline data which showed rapid and durable antidepressant outcomes following a single dose of BPL-003
• Breakthrough Therapy designation provides intensive FDA guidance to support advancement of BPL-003
  
   

 atai Life Sciences (NASDAQ:ATAI) ("atai" or "Company"), and Beckley Psytech Limited ("Beckley Psytech"), who previously announced a planned strategic combination to create a global leader in transformative mental health therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to BPL-003 (mebufotenin benzoate) nasal spray for adult patients with treatment-resistant depression (TRD).

BTD is granted to expedite development of drugs targeting serious or life-threatening conditions where preliminary clinical evidence suggests that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over existing therapies. The designation facilitates collaboration with the FDA and has the potential to expedite development timelines and regulatory reviews. BPL-003 is designed to deliver rapid and durable antidepressant effects from a single dose with a short therapeutic experience. The designation follows positive topline results from Beckley Psytech's Phase 2b core, blinded study of BPL-003 in TRD which showed that a single administration of 8 mg or 12 mg of BPL-003 led to clinically meaningful and statistically significant reductions in depressive symptoms within 24 hours, with effects sustained through the eight-week trial period. Notably, the majority of patients were deemed ready for discharge at the 90-minute post-dose assessment, underscoring the potential scalability of the BPL-003 treatment model and its potential to fit into the established two-hour, in-clinic interventional psychiatry treatment paradigm.

Cosmo Feilding Mellen, Chief Executive Officer and Co-Founder of Beckley Psytech, said, "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."

Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-Founder of atai Life Sciences, 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."

 

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