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—though some say it's time to look elsewhere. Also, Stat examines Lykos' journey to the thumbs-down FDA panel vote.
The Washington Post:
Pyschedelic Drug Boosters Assess Challenges After FDA Panel Turns Thumbs Down On MDMA
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)
Stat:
The Inside Story Of How Lykos’ MDMA Research Went Awry
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 “euphoria” that could be used to inform understanding of the drug’s addiction potential. The missing data, said clinical reviewer David Millis, were “a major concern.” (Goldhill, 6/9)
Politico:
Acid For The Ear
The Pentagon is investigating how psychedelic medicine can help servicemembers — 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 —
Politico:
Florida Pot Legalization Amendment Has A Surprising Opponent: Medical Marijuana Doctors
Florida’s ballot initiative to legalize recreational pot has divided the state’s growing medical marijuana industry. The state’s 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)
