Robert Langreth, Tiffany Kary and Fiona Rutherford | (TNS) Bloomberg News 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 .
