Lykos Reports 'Productive' FDA Meeting on Rejected MDMA Drug

Lykos Therapeutics shared a positive update regarding their recent interactions with the FDA on Friday. The company had an encouraging meeting with the regulatory body to plan the future steps for their program, which faced a setback when the FDA declined their application in August 2024.

Approximately nine weeks after the FDA rejected Lykos Therapeutics’ application for MDMA-assisted therapy aimed at treating post-traumatic stress disorder (PTSD), the company has moved forward by announcing a productive discussion with the agency. This meeting was led by the newly appointed interim CEO, Michael Mullette, and the newly appointed Chief Medical Officer, David Hough. According to the company's statement, the meeting resulted in a clear pathway forward, which includes conducting another Phase III trial and possibly having a third-party review of the previously collected Phase III data.

The FDA's Complete Response Letter dated August 9 stated that Lykos' application could not be approved based on the data submitted thus far and requested an additional Phase III trial to gather more comprehensive data on the safety and efficacy of MDMA. In response, Lykos expressed their intention to request a meeting with the FDA to seek reconsideration of the decision and to obtain recommendations for resubmission.

Former CEO Amy Emerson mentioned that conducting another Phase III study would likely take several years. Emerson, who was with Lykos for ten years, stepped down from her position in September. In her place, the company appointed Michael Mullette as interim CEO and David Hough as the new Chief Medical Officer, who will be leading the efforts to reapply with the FDA for the MDMA therapy.

Following the FDA's rejection, Lykos announced significant layoffs, reducing their workforce by about 75%. The remaining staff has been tasked with focusing on ongoing clinical development, medical affairs, and ongoing interactions with the FDA.

On Friday, Lykos reiterated their commitment to working with the FDA to finalize a comprehensive plan and assured that they would continue to provide updates as deemed necessary.