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Psychedelic drug MDMA faces questions as FDA considers approval for PTSD

The first new PTSD drug in over 20 years, a version of MDMA by Lykos Therapeutics Inc., is up for approval. Federal regulators must approve the mind-altering drug, also known as ecstasy.
Lykos Therapeutics Inc., a nonprofit-backed drugmaker, aims to bring psychedelic therapy to the masses with the new PTSD drug based on MDMA.
FDA scientists noted significant and lasting PTSD symptom improvements in patients who received MDMA alongside talk therapy, prompting questions about the drug's safety and efficacy.

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Ars Technica

FDA’s review of MDMA for PTSD highlights study bias and safety concerns

FDA advisors will meet June 4 to discuss and vote on the therapy's effectiveness.

10 months ago·United States

Illegal ecstasy takes step toward becoming legal drug for PTSD

The new drug is a version of MDMA, also known as ecstasy, made by Lykos Therapeutics Inc., an unusual drugmaker started by a nonprofit that has for decades advocated to bring psychedelic therapy to the masses.

10 months ago·Boulder, United States

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KIFI

Psychedelic drug MDMA faces questions as FDA considers approval for PTSD

By MATTHEW PERRONE AP Health Writer WASHINGTON (AP) — Federal health regulators are set to review the first request to approve the mind-altering club drug MDMA as a treatment for PTSD. The Food and Drug Administration posted its review of the drug on Friday, raising questions about its effectiveness and potential risks, including heart problems. The drug application is part of a decadeslong effort by advocates to move psychedelic drugs into the …

10 months ago·Idaho Falls, United States

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Associated Press News

+15 Reposted by 15 other sources

Psychedelic drug MDMA faces questions as FDA considers approval for PTSD

WASHINGTON (AP) — Federal health regulators are questioning the safety and evidence behind the first bid to use MDMA, the mind-altering club drug, as a treatment for PTSD, part of a decadeslong effort by advocates to move psychedelic drugs into the medical mainstream.The Food and Drug Administration posted its initial review of the drug Friday,...

10 months ago·United States

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CBS News

Psychoactive drugs like ketamine and MDMA are having a moment. The FDA will soon weigh in.

Drugs such as LSD, ketamine, mushrooms and MDMA can be powerful treatments for severe depression and PTSD, mounting evidence suggests — but not everyone is convinced.

10 months ago

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KFOR FM 103.3 1240 AM

Psychedelic Drug MDMA Faces Questions As FDA Considers Approval For PTSD - KFOR FM 101.5 1240 AM

Credit: MGNWASHINGTON (AP) — Federal health regulators are set to review the first request to approve the mind-altering club drug MDMA as a treatment for PTSD. The Food and Drug Administration posted its review of the drug on Friday, raising questions about its effectiveness and potential risks, including heart problems. The drug application is part of a decades-long effort by advocates to move psychedelic drugs into the medical mainstream. If a…

10 months ago

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