Lykos Optimistic on MDMA Treatment Post-FDA Meeting

Lykos Therapeutics recently held a significant meeting with the FDA to discuss the future of their PTSD treatment after its rejection. This was the company's first public communication since the difficult period spurred by the drug's denial. Interim CEO Michael Mullette and Chief Medical Officer David Hough represented Lykos in the meeting with the FDA.

The discussion resulted in a proposed path forward, which includes conducting an additional Phase 3 trial and possibly an independent third-party review of the previous Phase 3 clinical data. Lykos intends to collaborate with the FDA to finalize the plan for midomafetamine, a drug that is commonly known as the psychedelic MDMA.

The FDA's rejection of midomafetamine in August triggered a series of significant internal changes at Lykos, including severe layoffs and executive adjustments. Despite these challenges, the brief details from the meeting indicate that Lykos is unlikely to contest the FDA's decision to reject the drug.

In September, it was reported that Lykos planned to concentrate on raising funds to support another trial of midomafetamine. The potential impact of an independent review of the prior trials remains uncertain. The previous studies of the drug were scrutinized by an advisory board, which had largely opposed the approval of Lykos's application.

This meeting and subsequent cooperation with the FDA signify a crucial step for Lykos Therapeutics as they seek to advance the development of their PTSD treatment. The company's efforts will now focus on refining their strategy and securing the necessary support to move forward with another Phase 3 trial.