FDA rejects psychedelic drug therapy for PTSD

The FDA has rejected a treatment that paired therapy with a psychedelic drug, and requested the company behind the treatment to continue testing its therapy. 

The treatment from Lykos Therapeutics paired the psychedelic drug MDMA, also known as ecstasy, with therapy that proponents say would have been a boon for the future of psychedelics in treating post-traumatic stress disorder. 

The FDA said Friday that Lykos’ application had “significant limitations” that prevented the agency from concluding that the psychedelic would be safe and effective. The agency said it will continue encouraging “innovation for psychedelic treatments and other therapies to address these medical needs.”

“The agency recognizes that there is great need for additional treatment options for mental health conditions such as PTSD,” a spokesperson for the FDA told The Washington Times. “We will continue to encourage research and drug development that will further innovation for psychedelic treatments and other therapies to address these medical needs.”

Lykos said in a statement after the decision that the FDA requested the company conduct an additional trial to further study the safety and efficacy of MDMA. The company vowed to request a meeting with the FDA to ask the agency for “reconsideration of the decision.” 

“The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades,” said Lykos CEO Amy Emerson in a statement.

The agency’s decision followed a bipartisan push from lawmakers, along with hundreds of veterans and veterans organizations, that argued that approval of the novel treatment could reduce the number of suicides among veterans suffering from PTSD. 

A report published by the VA last year found that 6,392 veterans took their own lives in 2021 — an average of roughly 127 per day. Since 2001, nearly 150,000 veterans have committed suicide.

Approval of Lykos’ treatment was already in jeopardy following the near-unanimous decision by an FDA advisory panel in June that recommended against its approval. Indeed, the FDA’s decision echoed the advisory panel’s sentiments, Lykos said. 

Advisory panel members at the time raised concerns with allegations of ethical and sexual misconduct during treatment sessions, weak data and overall questions about long-term health effects and addictiveness from the usage of MDMA in Lykos’ therapy. The panel based its decision on data from two trials of roughly 200 participants with PTSD. 

Opponents of the Lykos treatment raised concerns with the company’s methodology, and warned that if the FDA had approved their pairing of MDMA and therapy, it could doom the future of psychedelics being used to treat PTSD. 

Psymposia, a nonprofit leftist media outlet that advocates for psychedelic therapies, applauded the agency’s decision in a statement to The Times, and noted that it now is a critical time for thoughtful action, accountability, and the establishment of the highest standards in psychedelic safety, efficacy, and harm reduction. 

“Our goal is to ensure that patients, veterans, and other vulnerable demographics seeking help are not exploited and abandoned by pharmaceutical companies,” they said. “This decision protects the future of the psychedelic field by avoiding a rush to market with preventable harms, as occurred in the opioid crisis.”