FDA Grants Priority Status to New MDMA Drug

A new age for psychedelics

We are on the verge of a psychedelic renaissance, with the Food and Drug Administration (FDA) accepting a new drug application for midmafetamine (MDMA) in February of this year. MDMA the active ingredient in the common party drug “ecstasy” or “molly”. If approved, the drug would be used to treat post-traumatic stress disorder (PTSD), and in early results from clinical trials, it has shown some promise in treating the condition.

The FDA has agreed to review a treatment protocol that would see MDMA used in a therapy assisted setting for treatment of the disorder, and the application has been granted priority status. A priority review designation means the FDA’s goal is to take action on an application within six months. While a final determination of the use of MDMA is pegged for August 11, 2024, the possibility of its acceptance has many excited.

Post Traumatic Stress Disorder

PTSD is notoriously difficult to treat, and with a shortage of effective treatment options, patients are often left to deal with PTSD on their own. PTSD is a debilitating psychiatric disorder that can develop after a traumatic life experience—reducing quality of life drastically. These traumatic events include natural disasters, serious accidents, rape, sexual assault, life threatening events, intimate partner violence, bullying, and even war. The condition is associated with high rates of disability, suffering and suicide.

MDMA as treatment

MDMA shows promise in treating the condition because its unique psychopharmacological effects can decrease feelings of fear, increase sociability, increase trust and radically change states of consciousness.

MDMA-assisted psychotherapy would be a new treatment for PTSD that includes both psychotherapy and the administration of MDMA. MDMA targets multiple neurotransmitters in the brain, including serotonin, noradrenaline, and dopamine, which are claimed to help the drug minimize fear responses, allowing for more in-depth therapy sessions that focus on the trauma an individual experienced.

Clinical trials

Clinical trials have been conducted, and the initial reports are that treatment with MDMA has been incredibly transformational. The evidence supporting MDMA’s use as a treatment option comes from two Phase III clinical trials that reviewed the effectiveness and safety of MDMA for treating moderate to severe PTSD.

However, recently, critics have attacked the clinical trials, expressing concern with the accuracy and validity of the results. Critics claim that the data might not be an accurate representation of what actually happened in the clinical trials. The concerns raised include that some therapists conducting the trials could have been encouraging favorable reports while discouraging negative reports, including minimizing the reporting of substantial harms. The studies, critics claim, involved inherent bias in accurately reporting the treatment’s benefits and harms, thereby obscuring the results. They also claim that the study was in effect unblinded, because nearly all patients who received MDMA in the study could correctly identify that they were in the group that received the actual drug rather than the placebo.

Despite the criticism, overall, the results from the clinical trials indicate that the treatment was well tolerated, and that some adverse effects, such as nausea, anxiety, and heart palpitations were not serious enough to warrant substantial concern.

Lykos Therapeutics

The company behind the trials is Lykos Therapeutics (“Lykos”), formerly MAPS Public Benefit Corporation. Lykos a company working to transform mental healthcare. We gave the backstory on Lykos and its founder here.

If this drug is approved, it would be the first psychedelic assisted therapy approved by the FDA. Amy Emerson, the CEO of Lykos, said there is an “urgent unmet need for innovation in the treatment of PTSD.” Lykos, she said, remains focused on working within the FDA review process and preparing for a controlled launch that ensures quality in the event the treatment is approved. Lykos is the first company to engage in a randomized, double-blind, placebo controlled clinical trials of MDMA.

If the drug is approved by the FDA, the Drug Enforcement Administration would need to reschedule MDMA. The overall results of the clinical trials thus far are that MDMA significantly reduced PTSD symptoms verses the placebo when combined with therapy.

For previous coverage on this drug application and topic, check out the following: