Press Release: MAPS is Granted Innovation Passport in United Kingdom for MDMA as an Adjunct to Therapy for PTSD

CANNANNEW REPORT

MDMA as an adjunct to therapy for PTSD is the forty-first treatment to receive the Innovation Passport since its inception in January 2021 The designation is intended to accelerate the timeline for approval of innovative medicines for treatment of life-threatening conditions or those which present a significant patient or public health need MAPS Public Benefit Corporation will coordinate trial design with Medicines and Healthcare products Regulatory Agency to create a road map for early patient access in the UK The Innovative Licensing and Access Pathway (ILAP) Innovation Passport has ben granted to MDMA as an adjunct to therapy for posttraumatic stress disorder (PTSD) in the United Kingdom (UK). The ILAP designation, authorized by a steering group of representatives from Medicines and Healthcare products Regulatory Agency (MHRA), National Health Services of England and Scotland, National Institute for Health and Care Excellence, Scottish Medicines Consortium, and representatives from the ILAP Patient and Public Reference Group, acknowledges that this treatment may have unique potential as a safe and effective treatment for PTSD, a widespread and devastating mental health condition with few successful treatment options. The Innovation Passport does not reduce the burden of demonstrating that a treatment may be safe and effective, but does provide research organizers with expert advice, patient input, and collaboration throughout the clinical trial design and development process through a product-specific Target Development Profile. This innovative approach to innovative treatments aligns key regulatory and healthcare systems across the UK to ensure all of the stakeholders who will be involved in making a treatment accessible are represented. Our promising Phase 3 results lead us to apply for the Innovation Passport. The ILAP Innovation Passport will ensure MDMA as an adjunct to therapy can be made widely available, as rapidly as possible, for the UK PTSD patients who need it. Berra Yazar-Klosinski, Ph.D., Chief Scientific…

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Source : Press Release: MAPS is Granted Innovation Passport in United Kingdom for MDMA as an Adjunct to Therapy for PTSD

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