Potential approval of MDMA to treat post-traumatic stress disorder cleared a major hurdle Tuesday, as a panel of outside advisers to the Food and Drug Administration voted against the treatment.
The committee voted nine against, two for, on whether there was enough data to show that the drug, which doctors call midomafetamine and sold illegally under the street drug name “ecstasy,” was effective. in the treatment of PTSD.
Although the FDA is not required to follow the committee’s votes, agency officials often follow the committee’s comments. Sometimes drug manufacturers end up having to conduct different studies before resubmitting them for approval to the FDA.
The agency is expected to rule by August 11 on Lykos Therapeutics’ current submission for the MDMA trial.
During the day-long meeting of the Psychopharmacological Drugs Advisory Committee, panelists questioned data gaps in studies submitted by drugmaker Lykos Therapeutics. Some members expressed concerns about how the studies were designed and their results, as well as the drugmaker’s failure to collect the data requested by the FDA.
Panelists also cited data suggesting the treatment may not offer a lasting treatment for PTSD, concerns over accusations that therapists mistreated patients in 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 reporting from patients, which could have biased results.
Lykos told the committee it investigated the accusations and adjusted its processes to prevent such conduct. The company said it was working with the FDA to develop training and guarantees this would protect vulnerable patients after approval.
FDA officials declined to answer questions raised by the committee about the specific allegations, only confirming that inspections “are underway” as a result of the allegations. They asked the committee not to take it into account in their votes.
“While we are aware of these reports, we consider them unverified at this point until we conduct our own inspections,” FDA’s Dr. Teresa Farchione told the committee.
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