Potential approval of MDMA to treat post-traumatic stress disorder hit a major hurdle Tuesday, as a panel of the Food and Drug Administration's outside advisers voted against the treatment.
The committee voted nine against, two in favor, on the question of whether there was enough data to show the drug was effective in treating PTSD. The drug, which doctors call midomafetamine, is sold illegally as the street drug ecstasy.
While the FDA is not required to follow the committee's votes, agency officials often follow the panel's feedback. Sometimes drugmakers end up having to run different studies before they resubmit for the FDA's approval.
The agency is expected to decide by Aug. 11 on the current submission by Lykos Therapeutics on trialing MDMA.
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During the Psychopharmacologic Drugs Advisory Committee's daylong meeting, panelists questioned gaps in data from studies submitted by drugmaker Lykos Therapeutics. Some members raised concerns about the ways the studies were designed and their results, along with the drugmaker's failure to collect data requested by the FDA.
Panelists also cited data suggesting the treatment may not offer a long-lasting treatment to PTSD, concerns over accusations about therapists abusing patients in the trials while they were under the influence of the drug or cited claims reported by the Institute for Clinical and Economic Review that therapists may have discouraged negative reports by patients, which may have biased results.
Lykos told the committee that it had investigated the accusations and had adjusted its processes to prevent such conduct. The company said it was working with the FDA to draw up training and safeguards that would protect vulnerable patients after approval.
FDA officials declined to answer questions the committee raised about the specific allegations, aside from confirming that inspections "are ongoing" in the wake of the claims. They asked the committee not to factor that into their votes.
"Although we are aware of those reports, we consider them to be unverified at this point until we do our own inspections," the FDA's Dr. Teresa Farchione told the committee.
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