US FDA panel to discuss first psychedelic-assisted PTSD treatment next
month
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 [May 07, 2024]
(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.
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A view shows the U.S. Food and Drug Administration (FDA)
headquarters in Silver Spring, Maryland August 14, 2012.
REUTERS/Jason Reed/File Photo/File Photo
 No psychedelic-based therapy has
been approved yet in the U.S., but MAPS and companies such as
Compass Pathways are testing such drugs to find cures for a range of
mental health disorders.
(Reporting by Pratik Jain in Bengaluru; Editing by Krishna Chandra
Eluri)
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