Business
Mindstate Design Labs has received approval for a Phase 1 clinical trial to investigate the use of its formulation of 5-MeO-MiPT which it hopes to combine with other drugs to target precise serotonin receptors and create future psychotropic therapies.
Lykos Therapeutics CEO Amy Emerson is being replaced by interim CEO Michael Mullette in a company restructuring that began after the FDA’s rejection of Lykos’ application for MDMA-Assisted Therapy for PTSD.
In the wake of the FDA’s rejection of its proposed MDMA-assisted therapy for PTSD, Lykos Therapeutics laid off approximately 100 employees and appointed new leadership while the MAPS nonprofit cut 33% of its workforce.
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.
