Lykos Therapeutics’ midomafetamine (MDMA) treatment for post-traumatic stress disorder (PTSD) has suffered another setback after the US Food and Drug Administration (FDA) refused to approve the therapy. On 9 August, Lykos said, the US regulatory agency issued a complete response letter (CRL) stating that the MDMA therapy “could not be approved based on data submitted to date” and asked Lykos to conduct another Phase III trial. The US-based company plans to ask the US FDA to reconsider its negative decision.
The gold standard of business intelligence. The FDA rejection was foreshadowed by the by the FDA’s Psychopharmacologic Drugs Advisory Committee (AdCom) in June. In a 9-2 vote, the AdCom found that available data did not show MDMA’s efficacy in PTSD.
The panel also voted 10-1, stating that the benefits of the drug do not outweigh its risks. Lykos questions however whether the AdCom properly considered the company’s candidate. In a press release, Lykos noted that “the company and other stakeholders have expressed concerns around the structure and conduct of the AdCom meeting, including the limited number of subject matter experts on the panel and the nature of the discussion, which at times veered beyond the scientific content in the briefing documents.
” The company plans to request a meeting with the FDA to discuss resubmission of MDMA’s new drug application (NDA). Amy Emerson, chief executive officer of Lykos said: “While conducting another Phase III st.