The U.S. Food and Drug Administration has set Sept. 6 for a “hybrid public meeting” to discuss potential new treatments for post-traumatic stress disorder, including psychedelic regimens, according to a notice from the agency.
The FDA – which just this month rejected a new drug application by Lykos Therapeutics to treat PTSD with MDMA-based therapy – plans a “panel discussion with federal partners to explore efforts to accelerate treatment development for PTSD, including psychedelic drug development,” according to the notice.
“This meeting will also provide an opportunity for people with lived PTSD experience, including veterans, family members, and patient advocates; researchers and scientists; and drug developers to provide public comment,” the FDA notice read.
But the two-and-a-half-hour meeting will be limited to just 30 participants with three minutes apiece to present any argument they may have in favor or against psychedelic treatment for PTSD.
Anyone wishing to participate must register in advance by Tuesday, Sept. 3, and those chosen to speak will be notified on Sept. 4, the FDA said. Written comments can also be submitted until Sept. 20.
The Lykos decision earlier this month – which was generally taken as a surprise setback by the psychedelics sector, given how much research the company had conducted already with patients – led that company to shed 75% of its staff and announce a reorganization plan so it can continue trying to bring its MDMA therapy to market. The company said it is still committed to that end goal.
In addition, Dr. Rick Doblin, the founder of the Multidisciplinary Association for Psychedelic Studies, chose to leave the Lykos board of directors, in part so he could be more free to advocate for psychedelic medicines.
Anyone wishing to speak at the meeting must register in advance by Tuesday, Sept. 3 on the FDA website.
This article was published by Green Market Report