The UK’s Medicines and Healthcare Products Regulatory Agency has granted an “Innovation Passport” to the drug MDMA, also known as “ecstasy” or “molly,” in the treatment of post-traumatic stress disorder.
The Innovation Passport, part of the Innovative Licensing and Access Pathway, is a designation by the country’s top health agency to reduce time to market for innovative medicines.
The designation was granted to the UK chapter of the Multidisciplinary Association For Psychedelic Studies, a nonprofit currently advancing a phase 3 trial with MDMA in the United States.
In MAPS’ phase 3 clinical trial conducted in the United States, Canada and Israel, 88% of participants who received the drug MDMA experienced a clinically significant reduction in symptoms. 67% no longer qualified for a PTSD diagnosis.
“Our promising Phase 3 results lead us to apply for the Innovation Passport,” said Berra Yazar-Klosinski, chief scientific officer at the MAPS Public Benefit Corporation.
MDMA-assisted psychotherapy is currently spearheading drug development efforts in the psychedelics sector and is expected to become the first psychedelic drug to be approved by the FDA in late 2022 or early 2023.
Similar to the FDA’s Breakthrough Therapy Designation, the Innovation Passport can help streamline access to MDMA as an adjunct to therapy for post-traumatic stress disorder. The Innovation Passport program was launched in January of 2021. Since then, forty other medical treatments have received the passport in the UK.
Photo from Wikimedia Commons: Ecstasy pills.
