Noah McCrory
Ahead of a key meeting on Tuesday to assess the potential midomafetamine approvalor MDMA, for patients with post-traumatic stress disorder, the Food and Drug Administration is proposing a new set of restrictions on how eligible patients could obtain the drug.
Details of the FDA’s proposal were published Friday in a set of documents released by the agency before an advisory committee. meeting next week.
After the panel’s vote, pharmaceutical company Lykos Therapeutics says the FDA is expected to make a decision until August 11th on the approval of their approach for patients with PTSD: a four-month course of MDMA combined with psychotherapy.
Among those at the FDA questions for the commission is whether the benefits of MDMAcombined with the FDA’s proposed restrictions on prescriptions for the hallucinogenic drug, will be enough to offset its risks.
“Patient impairment is an expected effect of midomafetamine administration and there must be safeguards to mitigate serious harm from patient impairment, similar to risk mitigation in clinical trials, to support patient safety,” the FDA reviewers said in an announcement. information document before the meeting.
Under the proposal, administration of MDMA would be restricted to healthcare facilities that agree to ensure that at least two providers are on site to monitor patients while they take the medication.
Patients will need to be monitored for at least eight hours until they are psychologically stable enough to be discharged to an adult following the session. During the tests, many ended up staying overnight in the study locations, being monitored by therapists.
Providers will also need to prepare for some physical risks. In the trials, one participant was hospitalized after it was suspected that MDMA exacerbated a pre-existing heart problem.
Patients will also need to be enrolled in a registry that tracks side effects and problems that arise in sessions, as well as how they are doing after completing treatment.
“We are also concerned about worsening psychological disorders that cause disability or that can lead to hospitalization or death, and suicidal behaviors and ideation,” the FDA said.
The drugmaker is also in talks with the FDA about other measures to reduce the drug’s risks, such as providing the product in single-dose packaging intended to limit the risk of “nonmedical use,” Lykos said in its report. information document.
The FDA often uses its authority to place additional restrictions on prescription drugs, called Risk assessment and mitigation strategies or REMS, to reduce the pitfalls of medicines that you otherwise believe would be too dangerous to be approved.
Nasal sprays of the hallucinogen esketamine to treat depression, from the brand Spravato, have also been approved in 2019 under these types of REMS restrictions.
Additional restrictions may be imposed by a different agency – the Drug Enforcement Administration – which will be responsible for “rescheduling” the drug.
The DEA currently considers MDMA or “ecstasy” be a Schedule I drug, alongside other substances like heroin that the DEA it says they have “no currently accepted medical use and a high potential for abuse.”
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