The Multidisciplinary Association for Psychedelic Studies (MAPS) has been granted the Innovation Passport for MDMA as an adjunct to therapy for post-traumatic stress disorder (PTSD).
Patients in the UK may see early access to MDMA as a therapy for PTSD. MDMA, administered as an adjunct to-trauma-focused therapy for PTSD, is currently being investigated through trials sponsored by MAPS and MAPS Europe B.V., with support from MAPS Public Benefit Corporation (MAPS PBC).
The passport has been granted under the UK’s new Innovative Licensing and Access Pathway (ILAP) scheme which aims to accelerate the approval timelines for medicines.
This will enable MAPS PBC to co-ordinate its clinical trial design with the Medicines and Healthcare products Regulatory Agency (MHRA), creating a road map for early patient access to the therapy.
Chief medical officer of MAPS PBC, Corine de Boer, M.D., Ph.D., commented: “In the last two years, we have all lost so much—an experience reflected in increasing rates of symptoms of serious mental health conditions.
“For many people who live with PTSD, an already-urgent need has been exacerbated by strains on healthcare systems, isolation, and loss of a sense of security.
“Despite the profoundly devastating effects of PTSD, few effective treatments are available. We commend the MHRA for recognising the seriousness of PTSD, a life-threatening condition with a profoundly unmet public health need, and the potential of MDMA-assisted therapy to be part of the solution.”
The scheme was launched in January 2021 in a bid to reduce the time to market for innovative medicines. As part of the scheme, the innovation passport enables successful applicants access to support at all stages of the design, development and approvals process, and the chance to gain regulatory and stakeholder input – although this does not guarantee approval by MHRA.
PTSD in the UK
There are currently limited treatment options for PTSD, meaning there is a desperate need for new ones.
In the UK in 2015 it is estimated that 3 per cent of people were living with PTSD – a condition which can be caused by traumatic events from military and combat service, to abuse, neglect and natural disasters. Symptoms include hypervigilance, insomnia, intense feelings of guilt or shame, apathy and avoidance responses, which can exacerbate isolation.
Left untreated, these symptoms can cause an increase in susceptibility to mood, anxiety and substance use disorders; suicidal ideation or attempts; autoimmune disorders such as arthritis and asthma; congestive heart disease and hypertension; ulcers; and epilepsy or neurologic disorders.
MDMA releases oxytocin, vasopressin, and prolactin – neurohormones linked with trust and bonding – and decreases activity in the amygdala, the region of the brain corresponding with fear and traumatic memories.
These unique effects are thought to contribute to MDMA’s effectiveness as a catalyst to therapy for people living with PTSD. No drug is without risks, so clinical trials have included careful investigation of possible adverse effects. Thus far, no serious unexpected safety signals have emerged and side effects have been found to be temporary and manageable in a clinical setting.
Early patient access to MDMA therapy
Any medicine granted an innovation passport under the new scheme must meet a number of criteria including being developed for a life-threatening or debilitating condition; having significant patient or public health need; and, having potential benefits to patients, for example.
Key partners of the scheme include MHRA, National Institute for Health and Care Excellence (NICE), the All Wales Therapeutics and Toxicology Centre and the Scottish Medicines Consortium (SMC). NHS England and NHS Improvement, Health Research Authority (HRA) and the National Institute for Health Research (NIHR) are also additional supporting partners.
The ILAP designation, authorised by a steering group of representatives from the key partners, has acknowledged that adjunct MDMA therapy may have unique potential as a safe and effective treatment for PTSD.
“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,” stated Berra Yazar-Klosinski, Ph.D., chief scientific officer at MAPS PBC.
“Our promising Phase III 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.”
As part of the adjunct MDMA therapy, preparatory and integration sessions are combined with three MDMA sessions, spaced a month or more apart – all administered by specially trained clinicians.
The treatment takes up to three months to complete and does not require ongoing medication. In the Phase III trial conducted in the United States, Canada, and Israel, 88 per cent of participants who received MDMA experienced a clinically significant reduction in symptoms, and 67 per cent no longer qualified for a PTSD diagnosis.
A total of 71 application have been submitted for the scheme so far, and MAPS is one of only 41 applications to have been successful.
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