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 .
