Ahead of a key meeting Tuesday to weigh the potential approval of midomafetamine, or MDMA, for patients with post-traumatic stress disorder, the Food and Drug Administration is proposing a new set of restrictions on how eligible patients would be able to get the drug.
Details of the FDA’s proposal were published Friday in a set of documents released by the agency ahead of an advisory committee meeting next week.
After the panel votes, drugmaker Lykos Therapeutics says the FDA is expected to make a decision by Aug. 11 on whether to approve its approach for patients with PTSD: a four-month course of MDMA combined with psychotherapy.
Among the FDA’s questions for the committee is whether the benefits of MDMA, combined with the FDA’s proposed restrictions on prescriptions for the hallucinogenic drug, will be enough to outweigh its risks.
“Patient impairment is an expected effect from midomafetamine administration and there must be safeguards to mitigate serious harm from patient impairment, similar to the risk mitigation in the clinical trials, to support patient safety,” the FDA’s reviewers said in a briefing document ahead of the meeting.
Under the proposal, administering MDMA would be restricted to healthcare facilities that agree to ensure at least two providers are onsite to monitor patients while taking the drug.
Patients will need to be monitored for at least eight hours, until they are psychologically stable enough to be discharged to an adult after the session. During the trials, many ended up staying overnight at study sites, being monitored by therapists.
Providers will also need to prepare for some physical risks. In the trials, one participant was hospitalized after MDMA was suspected to have exacerbated a pre-existing heart problem.
Patients will also need to be enrolled in a registry tracking side effects and issues that come up from the sessions, as well as how they are faring following completion of the treatment.
“We are also concerned about worsening of psychological disorders that cause disability or that may lead to hospitalization or death, and suicidal behaviors and ideation,” the FDA said.
The drugmaker has also been in talks with the FDA over other steps to curb risks of the drug, like providing the product in only single dose packages aimed at limiting the risk of “nonmedical use,” Lykos said in their briefing document.
The FDA often turns to its authority to apply additional restrictions on prescription drugs, dubbed Risk Evaluation and Mitigation Strategies or REMS, to curb the pitfalls of drugs that it thinks would otherwise be too dangerous to approve.
Nasal sprays of hallucinogen esketamine to treat depression, branded as Spravato, were also approved in 2019 under these kinds of REMS restrictions.
Additional restrictions could be imposed by a different agency – the Drug Enforcement Administration – which will be responsible for “rescheduling” the drug.
The DEA currently deems MDMA or “ecstasy” to be a Schedule I drug, alongside other substances like heroin which the DEA says have “no currently accepted medical use and a high potential for abuse.”
