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The FDA has rejected Lykos Therapeutics’ New Drug Application for MDMA-assisted therapy for PTSD and requested an additional Phase 3 study.
Researchers are considering more complex designs for clinical trials of psychedelic- assisted therapies that can better address concerns about the impact of placebo in blinded studies.
On July 16, the MAPS nonprofit responded to recommendations by FDA advisors against approval of MDMA-assisted therapy and put forward their goals for the future of the organization.
As Lykos Therapeutics awaits an FDA decision this week on its proposed MDMA-assisted therapy for PTSD, the company has announced new initiatives and measures for additional oversight if the therapy is approved.
In part two of our special report on the pending FDA decision on MDMA-Assisted Therapy we look at comments from stakeholders with PTSD and also veterans groups about the benefits of the treatment and possible bias by researchers and managers at Lykos Therapeutics.
As Lykos Therapeutics considers a Risk Evaluation and Mitigation Strategy for MDMA-assisted therapy, both supporters and detractors of MDMA-AT make their case for whether the treatment is safe for patients.
Lykos Therapeutics details how it is addressing questions raised by FDA advisors during a June 4 advisory meeting and how it will apply these insights to its Risk Evaluation and Mitigation Strategy.
Lykos Therapeutics addresses concerns from FDA Advisors about MDMA-assisted therapy and presents a forward looking plan.
The growing market for vaporizers that offers portable, disposable and convenient delivery systems for DMT, psilocybin, 2C-B and other psychedelic substances.
The executive director of the American Psychedelic Practitioners Association shares his vision for the professionalization of psychedelic-assisted therapy, as FDA approval seems likely this year.
