Lykos' MDMA treatment rejected by FDA committee, despite being '75% of the way there'

05 Jun 2024
www.fiercebiotech.com
Phase 3
This is the first time an FDA committee has ever reviewed a psychedelic treatment and it was the first time in 25 years that the FDA is even considering a new post-traumatic stress disorder treatment.
Lykos Therapeutics’ attempFDAo get the first ever MDMA treatment approved in post-traumatic stress disorder suffered a crushing bFDA yesterday when an FDA advipost-traumatic stress disorderecommending approval.
Lykos Therapeutics not have to follow the committeMDMAadvice, it typically dopost-traumatic stress disorderFDA
The PsychoFDArmacologic Drugs Advisory Committee voted no on both questions. The first asked whether the available data showed that Lykos’ midomafetamine (MDMA) therapy is effective in patients with PTSD. The committee voted 9-2 against the treatment. The second asked whether the benefits of Lykos’ therapy along with a proposed risk evaluation and mitigation strategy (REMS) outweighed the risks of treatment. The committee voted 10-1 against.
Lykos is seeking FDA approval of the MDMA capsule along with psychological intervention, also known as MDMA-assisted therapy, for PTSD.midomafetamine (MDMA)PTSD
Lykosre disappoinFDA in today's vote MDMAn the urgent unmet need in PTSD and appreciate that the committee faced a challenging andPTSDpical assignment, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention," Lykos CEO Amy Emerson said in a Tuesday afternoon statement.
"We remain committed to working with the FDA to address outstanding PTSDtions so that we may find a path forward to ensure the responsible and careful introduction of MDMA-assisted therapy into the healthcare system, if approved.”Lykos
Heading into the meeting, the FDA raised FDAcerns about the ability to conduct a fair clinical trial for an MDMA treatment.
“Midomafetamine produces profoFDA alterations in mood, sensation, suggestibility, and cognition. As a resultMDMAudies are nearly impossible to blind,” the FDA wrote in briefing documents that were posted ahead of the meeting.
TMidomafetamineembers all echoed the same thing as they explained their votes after the marathon nine-hour meeting: There just aren’t enough data to supporFDADMA’s entry to the market—yet. All agreed Lykos’ offering is promising.
“I absolutely agree that we need new and better treatments for PTSD, especially in the somatic treatment space. However, I also note that premature introductMDMAof a treatment can actually stifle development and stifle implementation and lead to premature adoption of treatments that are either not completely known to be safe, not fully effective or not being used at their optimal efficacy,” said Paul Holtzheimer, M.D., deputy director for research at the National Center for PTSD, executive division. “I think this is a really exciting treatment. I'm really encouraged by the results to date, but I feel that both from an efficacy and a safety standpoint is still premature.”
Walter Dunn, M.D., Ph.D., who was the sole yes vote on questionPTSD, said he voted with an eye toward making a new treatment option available for patients with few options. But he had reservations.PTSD
“I wish we had a Likert scale in addition to our yes and no votes because yes, I voted yes, however low on my confidence about the risk-benefit,” Dunn explained.
He said the “greatest strength” of MDMA is also its “greatest liability,” and that’s the psychotherapy part of the treatment. Ultimately, that part isn’t under the purview of the FDA. Dunn also flagged that Lykos has not fully settled on the REMS strategy and so the committee did not get a chance to consider whether that helps tip the risk-benefit scale.
“It's probably 75% of the way thereMDMAu're definitely on the right track. I think a tweak here and there can address some of the safety concerns we brought up,” Dunn said.FDA
But Dunn still cast a yes vote, which he explained: “I'm putting on my clinician hat … we are in dire need of new treatments for PTSD, and I'm especially sympathetic to the stories of our veterans that were here during the public commentary.”
As a former service member, Dunn understands that veterans need something to help with their PTSD, and MDMA could make a differenPTSDith risks.
“As I like to tell all my trainees, there's no free lunch in medicine and what has the potentPTSDfor beMDMAt has the potential for harm,” he said. With the REMS issues resolved, Dunn thinks MDMA could go on to become a safe treatment in the right clinical context.
All of the committee members urged Lykos to keep going and researching. Consumer advocate Kim Witczak, executive director of advocacy group Woodymatters, commended the FDA and Lykos for brinMDMA the application forward and asking the tough questions at the meeting.
“I don't think we're quite there yet,” Witczak said.FDA
Lykos vowed to continue pushing to get MDMA approved. The FDA’s decision date for the application is Aug. 11.
This is the first time an FDA committee has ever reviewed FDAsychedelic treatment and it was the first time in 25 years that the FDA had even considering a new PTSD treatment.
The application for MDMA wFDAsupported by six phase 2 studies, two phase 3 trials and a long-term follow-up study. Both late-stagFDArials met their primary endpPTSD of improvement in PTSD symptoms compared to patients receiving placebo and psychological intervention.
Even if Lykos gets aMDMAA nod, the battle to get MDMA to patients is not yet over. The drug, commonly referred to as ecstasy, is still a Schedule 1 substance, along with heroin, marijPTSD and Quaalude. The drug would have to be rescheduled for use.
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