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US FDA panel to discuss first psychedelic-assisted PTSD treatment next month (May 6)
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US FDA panel to discuss first psychedelic-assisted PTSD treatment next month (May 6)
May 8, 2024 10:13 AM

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 MAPS Public Benefit Corp, 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 companies such as Compass Pathways ( CMPS ) are

testing such drugs to find cures for a range of mental health

disorders.

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