'There’s a Need for This': Tennessee Approves Bill to Study Psychedelic Drug for PTSD, Addiction
- On Friday, the Food and Drug Administration issued national priority vouchers to three organizations studying psychedelic drugs for depression and post-traumatic stress disorder , including psilocybin and methylone.
- President Donald Trump signed an executive order last weekend directing federal agencies to accelerate research and reduce restrictions on hallucinogenic compounds to address the national mental health crisis.
- Separately, the FDA authorized an early-phase clinical study of noribogaine hydrochloride by biopharmaceutical company DemeRx NB for alcohol use disorder, marking the first U.S.-based trial of an ibogaine-related agent.
- HHS Secretary Robert F. Kennedy Jr. stated the government is accelerating access to these treatments, while FDA Commissioner Marty Makary emphasized development must remain "grounded in sound science and rigorous clinical evidence."
- Industry leaders praised the initiative, though critics including former FDA chief counsel Dan Troy expressed concern that White House involvement could compromise the agency's independence and historically rigorous approval standards.
13 Articles
13 Articles
FDA Plans Ultra-Fast Review of Three Psychedelics for Depression, PTSD
(MedPage Today) -- The FDA said Friday it will offer ultra-fast review to three psychedelic drugs being developed for hard-to-treat forms of depression and post-traumatic stress disorder (PTSD), the latest step by the Trump administration toward...
FDA approves three fast-track studies of psychedelic drugs to treat PTSD, depression
The FDA did not specify what companies will conduct the research, but two of the companies are studying psilocybin. The third company is studying methylone, which is similar to the psychedelic MDMA, as a possible treatment for PTSD.
Is psychedelia making a comeback? The limits of the medical use of hallucinogens
U.S. President Donald Trump signed an executive order on April 18 that will expand and fund research into the use of psychedelic substances to treat mental health issues. For the first time in decades, the federal government is not just tolerating or indirectly funding research into psychedelic substances. This time Trump has decided to actually promote it at the federal level, focusing his efforts above all on ibogaine. But this is not the only…
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