So, no Ecstasy for PTSD--so surprised...not. This may have some benefit for some vets...but a drug that makes you highly suggestible..and horny would raise a lot of red flags for me!
More research..no rush to approve needed.
www.cbsnews.com
Potential approval of MDMA to treat post-traumatic stress disorder hit a major hurdle Tuesday, as a panel of the Food and Drug Administration's outside advisers voted against the treatment.
The committee voted nine against, two in favor, on the question of whether there was enough data to show the drug was effective in treating PTSD. The drug, which doctors call midomafetamine, is sold illegally as the street drug ecstasy.
While the FDA is not required to follow the committee's votes, agency officials often follow the panel's feedback. Sometimes drugmakers end up having to run different studies before they resubmit for the FDA's approval.
The agency is expected to decide by Aug. 11 on the current submission by Lykos Therapeutics on trialing MDMA.
More research..no rush to approve needed.
FDA panel votes against MDMA for PTSD, setting up hurdle to approval
FDA advisers cited a variety of concerns with the trials submitted by Lykos Therapeutics as part of the application.
www.cbsnews.com
Potential approval of MDMA to treat post-traumatic stress disorder hit a major hurdle Tuesday, as a panel of the Food and Drug Administration's outside advisers voted against the treatment.
The committee voted nine against, two in favor, on the question of whether there was enough data to show the drug was effective in treating PTSD. The drug, which doctors call midomafetamine, is sold illegally as the street drug ecstasy.
While the FDA is not required to follow the committee's votes, agency officials often follow the panel's feedback. Sometimes drugmakers end up having to run different studies before they resubmit for the FDA's approval.
The agency is expected to decide by Aug. 11 on the current submission by Lykos Therapeutics on trialing MDMA.
