May 6 (Reuters) - The U.S. FDA's panel of independent
advisers will on June 4 deliberate whether they should recommend
approval for the first MDMA-assisted therapy for post-traumatic
stress disorder, Lykos Therapeutics said on Monday.
This would be the first FDA panel of outside experts to
review a potential new PTSD treatment in 25 years.
PTSD is a disorder caused by very stressful events and can
significantly disrupt patients' lives.
Decades of studies has shown that psychoactive ingredients,
whether derived from cannabis, LSD or magic mushrooms, have long
captivated mental health researchers in their quest for
treatments.
In support of its application, Lykos Therapeutics, formerly
known as Multidisciplinary Association for Psychedelic Studies
(MAPS), studied the party drug MDMA, more commonly called
ecstacy or molly, in two late-stage studies.
The drug is intended to be used in combination with
psychological intervention, which includes psychotherapy, or
talk therapy, and other supportive services provided by a
qualified healthcare provider.
No psychedelic-based therapy has been approved yet in the
U.S., but MAPS and companies such as Compass Pathways ( CMPS )
are testing such drugs to find cures for a range of mental
health disorders.