With Info Gleaned From MDMA Vote, Developers Press On With Psychedelics
Enthusiasm has not diminished among researchers, biotech executives and investors to find a new treatment for patients with mental health disorders鈥攖hough some say it's time to look elsewhere. Also, Stat examines Lykos' journey to the thumbs-down FDA panel vote.
Developers of mind-bending drugs for medical use are distancing themselves from the first company to seek regulatory approval for a psychedelic compound, after its application encountered strong opposition from a government panel. ... But biotech executives, investors and researchers said in interviews that their enthusiasm for psychedelics to treat mental health disorders remains undimmed. They are betting that a by-the-books clinical trial design run by a more conventional drugmaker will ultimately succeed. (Gilbert and Ovalle, 6/8)
At a heated advisory committee meeting convened by the Food and Drug Administration last week, regulators repeatedly expressed frustration that Lykos, a company seeking approval of MDMA-assisted therapy to treat PTSD, failed to follow instructions and track positive feelings such as 鈥渆uphoria鈥 that could be used to inform understanding of the drug鈥檚 addiction potential. The missing data, said clinical reviewer David Millis, were 鈥渁 major concern.鈥 (Goldhill, 6/9)
The Pentagon is investigating how psychedelic medicine can help servicemembers 鈥 beyond mental health issues. The agency has awarded $825,000 to Boston-based Delix Therapeutics for the development of a nonhallucinogenic version of the famed counterculture drug LSD to treat hearing loss. Delix is among several pharmaceutical companies developing drugs that are structurally similar to psychedelics but without the characteristic high. (Reader, Odejimi, Paun, Payne and Schumaker, 6/7)
In marijuana news 鈥
Florida鈥檚 ballot initiative to legalize recreational pot has divided the state鈥檚 growing medical marijuana industry. The state鈥檚 largest medical marijuana company has bankrolled Amendment 3, which would legalize recreational marijuana for adults 21 and older. But some of the roughly 2,000 doctors who are state-certified to recommend pot as medicine are warning patients about the consequences that could jeopardize access to the drug for medicinal purposes. (Sarkissian, 6/7)