The FDA has requested additional phase 3 trials for MDMA-assisted psychotherapy for PTSD, putting a hold on potential landmark approval. Despite this setback, Lykos Therapeutics remains committed to navigating the FDA’s requirements, while other psychedelic therapies continue to progress in clinical trials.
The FDA’s rejection of MDMA-assisted therapy for PTSD has stirred controversy within the psychedelic medicine community, highlighting safety concerns and pushing for regulatory reform. Experts like April Pride, CEO of SetSet, advocate for specialized pathways to expedite research and ensure patient safety while addressing potential risks.
The Thane Police Anti-Narcotics Squad apprehended two interstate drug smugglers and seized 476 grams of MDMA, valued at Rs 95.20 lakh. The operation was conducted under the direction of the Thane Police Commissioner to crack down on the distribution, sale, and consumption of illegal drugs in the city.
The global market for psychedelic drugs is projected to experience significant growth in the coming years, driven by the increasing recognition of their therapeutic potential for mental health conditions. The market is attracting investment and research, with companies developing innovative therapies using substances like ketamine, psilocybin, and MDMA. However, regulatory hurdles and ethical concerns remain significant challenges.
Drug Science and University College London (UCL) have announced a strategic partnership to further investigate the efficacy of MDMA-assisted psychotherapy. This collaboration aims to address concerns raised by the FDA regarding the therapy’s regulation and therapist training, focusing on understanding the intricate interplay between MDMA and various psychotherapeutic approaches. The research will involve studying how different therapeutic modalities impact the effectiveness of MDMA treatment, ultimately aiming to provide a clearer understanding of the therapy’s potential for treating mental health conditions.
Emory University researchers have been awarded a $200,000 grant by the Multidisciplinary Association for Psychedelic Studies (MAPS) to conduct a pilot study exploring the potential of MDMA-assisted therapy in combination with Massed Exposure Therapy (MPE) for treating Post-Traumatic Stress Disorder (PTSD). This study, led by renowned PTSD treatment expert Dr. Barbara Rothbaum, aims to investigate the synergistic effects of these two therapies in helping individuals process traumatic memories and reduce distress.
The Food and Drug Administration (FDA) is considering whether to approve MDMA, also known as ecstasy or molly, to treat post-traumatic stress disorder (PTSD). This decision could be a significant moment for the future of psychedelic medicine, particularly for veterans who have reported significant relief from their PTSD symptoms using MDMA-assisted therapy. The FDA is expected to make a decision by August 11th, and the impact on veterans and the healthcare system could be profound.
Psychedelic-assisted therapy using substances like ketamine, MDMA, and psilocybin has gained attention for its potential benefits in treating mental health conditions. However, a recent study highlights the crucial role of strong relationships between patients and therapists in determining the effectiveness of psilocybin therapy for depression. The study suggests that a positive therapeutic alliance fosters long-term efficacy and positive psychological insights, emphasizing the importance of a supportive and safe environment for psychedelic experiences.
Actress Rebel Wilson has made a shocking claim in her new memoir, alleging that she was invited to a drug-fueled orgy by an unnamed member of the British royal family. The incident reportedly occurred at a medieval-themed party in Los Angeles in 2014, and Wilson says the royal in question was “fifteenth or twentieth in line to the British throne.”
