MDMA Breakthrough San Jose Company: Multidisciplinary Association for Psychedelic Studies (MAPS), a San Jose medical business, has taken a major step toward approving MDMA-assisted PTSD treatment. MAPS has applied to the FDA to provide MDMA pills with talk therapy. This would be the first US psychedelic-assisted therapy if approved.
With 60 days to study the new drug application, the FDA must decide. Further review should take 6-10 months if accepted. The FDA would approve MDMA-assisted PTSD treatment if the review is successful. The DEA would need to reschedule MDMA for medicinal use after FDA approval..
The application submitted by MAPS to the FDA includes results from two randomized, double-blind, placebo-controlled studies that assessed the effectiveness and safety of MDMA-assisted therapy. These studies represent a culmination of over 30 years of clinical research, advocacy, collaboration, and dedication, according to Amy Emerson, CEO of MAPS.
MAPS hopes that the potential approval of MDMA-assisted therapy will bring a new therapeutic option to adults living with PTSD. This patient group has seen limited innovation in treatment options over the past few decades. The application signals a significant milestone in the field of psychedelic-assisted therapy and may lead to increased investment in mental health research.
As of now, no regulatory agency has approved MDMA-assisted therapy, emphasizing the importance of this application’s potential impact on mental health treatment methodologies. The application process reflects a long-term commitment to advancing psychedelic-assisted therapies as viable and effective options for addressing mental health challenges.
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Our Reader’s Queries
Does MDA help with PTSD?
Although MDMA-assisted psychotherapy has proven to be a successful treatment for PTSD patients with a safe track record, the use of unregulated MDMA or administering it without a closely monitored psychotherapeutic setting can pose significant risks. It’s crucial to ensure that the therapy is conducted in a controlled environment to avoid any potential harm.
What is the breakthrough treatment for PTSD?
In 2017, the F.D.A. gave MDMA-assisted therapy a “breakthrough therapy” status for treating PTSD. This designation speeds up the development of promising experimental drugs. Similarly, psilocybin-assisted therapy for treatment-resistant depression was granted breakthrough status in 2018.
What is MDMA therapy used for?
MDMA-assisted psychotherapy has the potential to aid in the treatment of various disorders linked to attachment insecurities. These include PTSD, depression, anxiety disorders, obsessive-compulsive disorder, suicidality, substance use disorders, and eating disorders. By utilizing this form of therapy, individuals may be able to find relief from their symptoms and improve their overall well-being.