On Friday, two days ahead of schedule, the FDA handed Lykos Therapeautics a complete response letter for the drugmaker's midomafetamine capsules for PTSD.
In the letter, the agency communicated that the NDA could not be approved based on the data submitted and requested that Lykos conduct an additional phase 3 trial to further study the safety and efficacy of midomafetamine.
The issues expressed in the CRL echo those raised during the FDA AdComm meeting back in June, where the Psychopharmacologic Drugs Advisory Committee voted against treatment's approval on the grounds of both efficacy (2-9 against) and risk benefit (1-10 against).
There have been concerned expressed about the AdComm meeting, however, including the limited number of subject matter experts on the panel and the nature of the discussion, which, according to Lykos, went beyond the scientific content in the briefing documents. Lykos has previously published a response to the issues discussed at the hearing, including concerns that Lykos' clinical data were insufficient to demonstrate durability along with questions about expectancy bias stemming primarily from participants with prior MDMA use.
If it had been approved, the treatment — which involves MDMA capsules used in combination with psychological intervention — would have be the first psychedelic-assisted therapy approved for PTSD and the first new treatment for PTSD in more than two decades.
Lykos says it plans to request a meeting with the FDA to ask for reconsideration of the decision and to further discuss the agency's recommendations for a resubmission.
