This popular circuit party drug might get FDA approval… but there’s a catch

Experts at the Food and Drug Administration (FDA) are due to meet on June 4 to mull whether to approve ecstasy (MDMA) for the treatment of Post-Traumatic Stress Disorder (PTSD).

The move comes after a pharma company, Lykos Therapeutics, conducted two trials of the drug as a potential therapy aid.

PTSD is a mental health condition induced by living through a traumatic event. It can include many symptoms, including anxiety, difficulty sleeping, flashbacks and nightmares.

PTSD can be caused by one-off events, such as surviving an accident or violent crime, or from sustained abuse or trauma. A study last year concluded LGBTQ people are more likely to suffer from PTSD. It can be sometimes linked to the discrimination or harassment they experience.

Living with certain health conditions can also induce PTSD. A 2020 study found that over a quarter of people living with HIV displayed signs of PTSD.

Ecstasy, also known as Molly, is the street name for MDMA. The psychoactive drug was first synthesized in 1912. Psychotherapists in some countries briefly used it as a therapeutic tool in the 1970s. However, its use as a recreational drug exploded in the 1980s. Most users report feeling happy, blissful, affectionate toward others, energized and alert.

As its popularity in club culture grew, authorities cracked down on its use and distribution. It is illegal in the US.

Like many other street drugs, dealers often chop ecstasy with other drugs. Some of these, such as opioids, may be much more dangerous than MDMA.

Promising trial results

NBC News says this is the first time the FDA has considered a new medication for PTSD in 25 years. The condition is usually treated with anti-depressants and talking therapies.

Lykos Therapeutics has conducted several studies on how psychoactive substances might aid mental health disorders.

Lykos conducted two, double-blind, placebo-controlled trials that used ecstasy. It found participants who took ecstasy and engaged in talking therapies showed significantly fewer PTSD symptoms after just three sessions.

The company has now applied for approval from the FDA. In a news release, Amy Emerson, Chief Executive Officer of Lykos said, “We look forward to the opportunity to discuss the comprehensive data package of investigational MDMA and how, if approved, it may be used as a prescription treatment in combination with psychological intervention in adults with PTSD.”

Australia approves MDMA to treat PTSD

If the FDA approves MDMA for PTSD treatment, it will follow in the footsteps of Australia. Last year, it changed the classification of psilocybin (an hallucinogenic drug) and MDMA. Psychiatrists can now prescribe them for therapeutic purposes. Specifically, Australia now allows MDMA to be used to treat PTSD and psilocybin for treatment-resistant depression.

Similarly, earlier this year, the FDA designated a form of LSD as a breakthrough therapy to treat generalized anxiety disorder.

“Breakthrough therapy” status speeds up the development and review of drugs intended to treat a serious condition where early evidence indicates the drug may be better than available therapies. It might ultimately lead to a form of LSD being used to treat some forms of anxiety.