Psychedelic drugs continued to make regulatory and clinical headway, as non-believers converted to believers in the category once regarded with skepticism, to say the least.
Speculation about potentially wider meaning among developers of psychedelic drugs was reignited after the complete response letter (CRL) from the U.S. FDA to Lykos Therapeutics Inc. for midomafetaminecapsules, which the company wants to use in combination with psychological intervention to treat post-traumatic stress disorder (PTSD). CEO Amy Emerson called the FDA move “deeply disappointing,” adding that San Jose, Calif.-based Lykos plans to request a meeting with the FDA to ask for reconsideration.
Although the U.S. FDA unexpectedly sprang the news on Eli Lilly and Co. that it would hold an advisory committee meeting on the BLA for the company’s Alzheimer’s disease drug, donanemab, the agency’s briefing document for the June 10 meeting doesn’t appear to hold any surprises.
The discussion that preceded the June 4 U.S. FDA advisory committee vote against the approval of Lykos Therapeutics Inc.’s midomafetamine as a treatment for post-traumatic stress disorder could shine some light on the way forward for other sponsors developing psychedelics for approved medical use.
Although several members of the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee said they thought Lykos Therapeutics Inc.’s midomafetamine (MDMA), used in combination with psychotherapy, is a promising treatment for post-traumatic stress syndrome, they were not ready to endorse its approval.
Unblinding, zealous therapists, severity of harms, abuse potential and actual benefit could all be part of the conversation June 4 when the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee meets in person for the first time since the COVID-19 lockdowns to consider the use of a psychedelic drug, guided by psychotherapy, to treat post-traumatic stress disorder, or PTSD.
Alto Neuroscience Inc.’s start this spring of the phase II double-blind, single- and multiple-dose study to test the pharmacodynamics of ALTO-203 in major depressive disorder represents another stake planted in a notoriously difficult indication. But getting attention as well is the push by Los Altos, Calif.-based Alto in post-traumatic stress disorder (PTSD) with a separate compound.
Right on cue, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) is scheduling its first in-person advisory committee meetings since the COVID-19 pandemic. Speaking during a May 6 webinar hosted by the Alliance for a Stronger FDA, CDER Director Patrizia Cavazzoni said the center was preparing to go back to in-person adcoms, adding that the first step likely would be a hybrid model.
Right on cue, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) is scheduling its first in-person advisory committee meetings since the COVID-19 pandemic. Speaking during a May 6 webinar hosted by the Alliance for a Stronger FDA, CDER Director Patrizia Cavazzoni said the center was preparing to go back to in-person adcoms, adding that the first step likely would be a hybrid model.
