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Illegal ecstasy takes step toward becoming legal drug for PTSD

Robert Langreth, Tiffany Kary and Fiona Rutherford, Bloomberg News on

Published in Health & Fitness

The first new PTSD drug in over twenty years is up for approval. It will require U.S. regulators to do something they've never done before: greenlight the mind-altering — and illegal — party drug known as ecstasy.

The new drug is a version of MDMA, also known as ecstasy, made by Lykos Therapeutics Inc., an unusual drugmaker started by a nonprofit that has for decades advocated to bring psychedelic therapy to the masses.

On June 4, the public will gain the first hint of how regulators are leaning when outside experts on the Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee debate the data during a daylong session where both the company and FDA officials are expected to make their case. A decision on whether to approve the drug is likely by August.

“Everything about this is unprecedented,” said Jonathan Alpert, chair of the council on research at the American Psychiatric Association.

Lykos, which is privately held, has proposed its pill be given in conjunction with 42 hours of talk therapy with two therapists, including three day-long sessions involving MDMA.

“We're on the precipice of integrating psychedelic medicine into mainstream medicine,” Lykos Chairman Jeff George said speaking at a recent psychedelics conference in New York. Some 13 million Americans have PTSD.

 

Upping the ante, one influential government organization is already gearing up to provide the drug should it be approved. The Department of Veterans Affairs, which runs the country's largest health system and has an outsized PTSD patient population, says psychedelics have “significant potential.” PTSD is a psychiatric disorder experienced after a traumatic event, like combat.

The FDA faces a dilemma. Controversy over Lykos’ trial has exploded in recent weeks after a prominent group that assesses new treatments cited “substantial concerns about the validity of the results.” In a 44-page report released in March, the Institute for Clinical and Economic Review concluded that the evidence was “insufficient” to determine whether MDMA-assisted therapy has value. At a public meeting held by ICER on Thursday, debate over whether benefit outweighed risk for Lykos’ treatment was sometimes heated. In a vote, ICER advisers decided nearly unanimously that Lykos had not proven that the treatment was beneficial.

Chief among ICER’s concerns was whether the trial could adequately prove MDMA worked because people on the therapy knew whether they had been given the psychedelic drug. The gold standard in research is what's known as a “double-blind” trial, meaning neither patient nor provider know who’s on an experimental drug or a placebo in order to truly evaluate the difference. That wasn't the only problem.

“If you wanted to develop a study that would have every fatal flaw, you couldn’t do better than what was done for MDMA,” said Allen Frances, former chair of the psychiatry department at Duke University, who calls psychedelics the latest in a long series of overhyped psychiatry fads. The drug “is being rushed way too soon to commercial markets.”

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