Mysterie
Bluelight Crew
- Joined
- May 7, 2010
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writer: janet burns
published: 28/8
Following years of lobbying and laboratory research on the medical uses of methylenedioxymethamphetamine, or MDMA, the U.S. Food and Drug Administration has decided to move forward with the drug.
Last week, the Multidisciplinary Association for Psychedelic Studies (MAPS) announced that the FDA has granted Breakthrough Therapy Designation to MDMA for the treatment of post-traumatic stress disorder (PTSD). Popularly known as a recreational drug, and as the main ingredient in ecstasy, MDMA has been shown to offer significant relief for sufferers of PTSD in clinical use trials conducted over the past several years, leading to the U.S. agency's decision.
MAPS, which has been championing and fundraising for MDMA research for roughly 30 years, explained in a press release that the FDA's granting of a Breakthrough Therapy Designation indicates the agency "has agreed that this treatment may have a meaningful advantage and greater compliance over available medications for PTSD." It also designates the agency's intent to help develop and review the treatment faster than other candidate therapies.
According to MAPS, the non-profit organization has reached an agreement with the FDA under the Special Protocol Assessment Process for the design of two Phase 3 trials for MDMA-assisted psychotherapy for patients with severe PTSD in the near future.
"Reaching agreement with [the] FDA on the design of our Phase 3 program and having the ability to work closely with the agency has been a major priority for our team," said Amy Emerson, Executive Director of the MAPS Public Benefit Corporation, in a release. "Our Phase 2 data was extremely promising with a large effect size, and we are ready to move forward quickly. With breakthrough designation, we can now move even more efficiently through the development process in collaboration with the FDA to complete Phase 3."
read the rest of the article here
published: 28/8
Following years of lobbying and laboratory research on the medical uses of methylenedioxymethamphetamine, or MDMA, the U.S. Food and Drug Administration has decided to move forward with the drug.
Last week, the Multidisciplinary Association for Psychedelic Studies (MAPS) announced that the FDA has granted Breakthrough Therapy Designation to MDMA for the treatment of post-traumatic stress disorder (PTSD). Popularly known as a recreational drug, and as the main ingredient in ecstasy, MDMA has been shown to offer significant relief for sufferers of PTSD in clinical use trials conducted over the past several years, leading to the U.S. agency's decision.
MAPS, which has been championing and fundraising for MDMA research for roughly 30 years, explained in a press release that the FDA's granting of a Breakthrough Therapy Designation indicates the agency "has agreed that this treatment may have a meaningful advantage and greater compliance over available medications for PTSD." It also designates the agency's intent to help develop and review the treatment faster than other candidate therapies.
According to MAPS, the non-profit organization has reached an agreement with the FDA under the Special Protocol Assessment Process for the design of two Phase 3 trials for MDMA-assisted psychotherapy for patients with severe PTSD in the near future.
"Reaching agreement with [the] FDA on the design of our Phase 3 program and having the ability to work closely with the agency has been a major priority for our team," said Amy Emerson, Executive Director of the MAPS Public Benefit Corporation, in a release. "Our Phase 2 data was extremely promising with a large effect size, and we are ready to move forward quickly. With breakthrough designation, we can now move even more efficiently through the development process in collaboration with the FDA to complete Phase 3."
read the rest of the article here
