A pharmaceutical version of MDMA, also known as midomafetamine, could become a new treatment for PTSD… as advisers to the U.S. Food and Drug Administration are considering whether to recommend it for approval.
The panel met on Tuesday to discuss a treatment developed by Lykos Therapeutics… which has conducted two controlled trials to test how MDMA can help those suffering from PTSD in addition to therapy.
Of course, MDMA is better known as the party drug Molly, or ecstasy.
The panel’s treatment consideration is historic, as the CEO of Lykos Therapeutics Amy Emerson noted in a statement… “This will be the first MDMA-assisted therapy and psychedelic-assisted therapy to be reviewed by the Psychopharmacological Drugs Advisory Committee, a significant milestone in the field of psychedelic medicine, resulting from decades of clinical research and advocacy.”
In FDA briefing documents released Friday, data from Lykos Therapeutics’ clinical trials showed that “participants appear to experience rapid, clinically meaningful, and durable improvement in their PTSD symptoms.”
However, there are still some concerns… as the medicine is known to cause deficiencies, which could create a risk for the user.
If the drug is approved, the FDA has stated that safeguards must be implemented for a future clinical trial – namely, participants will have to be monitored by 2 therapists for an 8-hour period and will not be able to drive until the next one. day.
The FDA will reportedly make a decision by August 11, as the agency typically follows recommendations issued by the advisory panel.
MDMA… is no longer just your kids’ molly, potentially.