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news.Mind Medicine (MindMed) has received the innovation passport designation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its MM120 Orally Disintegrating Tablet (ODT) as a potential treatment for generalised anxiety disorder (GAD).
The tablet is used for the treatment of generalised anxiety disorder. Credit: Hal Gatewood on Unsplash.
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This designation marks the beginning of the UK Innovative Licensing and Access Pathway (ILAP), which is designed to expedite the development and access of new medicines in the UK region.
It offers recipients access to various developmental tools and opportunities for enhanced input from regulatory bodies and other stakeholders in the UK including the possibility of a shortened 150-day review for marketing authorisation application, a rolling review process, and ongoing benefit-risk assessments.
The ILAP is a collaborative effort involving the MHRA, the National Institute for Health and Care Excellence; the All Wales Therapeutics and Toxicology Centre, and the Scottish Medicines Consortium.
MindMed CEO Rob Barrow said: “Receiving the Innovation Passport designation is recognition of MM120 ODT’s potential to address GAD, one of the most critical and underserved needs in mental health.
“Following the receipt of Breakthrough Therapy Designation by the US Food and Drug Administration, the Innovation Passport designation underscores our commitment to bringing MM120 ODT to people living with GAD and our dedication to working closely with the MHRA to expedite patient access.
“We are determined to offer new hope and transformative solutions where current treatments have failed to meet the needs of those who suffer from this serious condition.”
MM120 ODT utilises Catalent’s Zydis ODT technology, which allows for faster dissolution, enhanced bioavailability, and fewer gastrointestinal side effects.
A Phase III clinical development programme for the therapy encompasses the Voyage and Panorama studies for GAD and the Emerge study for major depressive disorder (MDD).
