Small Pharma Granted Fast-Track Designation From U.K. Regulator for DMT-Assisted Therapy for Major Depressive Disorder
Small Pharma Inc. (CVE: DMT)(OTCMKTS: DMTTF), a neuropharmaceutical company focused on psychedelic-assisted therapies, is pleased to announce that following discussions with the U.K. Medicines and Healthcare products Regulatory Agency (the “MHRA”), Small Pharma has been granted an Innovation Passport Designation for SPL026, the lead product candidate from its pipeline of N,N-dimethyltryptamine (“DMT”) assisted therapies for the treatment of major depressive disorder (“MDD”).
Similar to the FDA’s fast-track in the United States, the U.K.’s MHRA Innovation Passport provides us with access to specialist advice throughout the drug development process and has the potential to enable a speedier, more efficient development process for SPL026, the lead candidate in our psychedelic-assisted therapy approach for the treatment of MDD. SPL026 entered clinical trials at the beginning of 2021 and this designation marks an important step forward towards an accelerated drug approval pathway for bringing the benefits of SPL026 to market for patients suffering with MDD.Dr. Carol Routledge, Chief Medical and Scientific Officer of Small Pharma
The Innovation Passport is an innovative medicine designation that provides access to the Innovative Licensing and Access Pathway (the “ILAP”). The ILAP accelerates time to market and facilitates patient access to emerging and novel treatments. The ILAP provides a single integrated platform for sustained collaborative working among the MHRA, its partners and the medicine developer, which allows for enhanced coordination and monitoring of important product development activities culminating in market authorisation. Under the ILAP, Small Pharma will have access to a toolkit to support all stages of the design, development and approvals process, as well as identify key areas for future engagement.
ILAP partners with a number of key regulatory bodies in order to enable earlier engagement and support to the companies selected for the ILAP. This has the potential to allow the National Health Service England (the “NHS England”) to adopt potential treatments faster and ultimately enable quicker patient access to these potential medicines. Key partnering stakeholders include the MHRA, the U.K.’s public body responsible for evidence-based evaluations of novel treatments, the National Institute for Health and Care Excellence, as well as the NHS England, the Scottish Medicines Consortium, NHS Improvement Health Research Authority, and the National Institute for Health Research.
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