- Small Pharma (DMT) has been granted fast-track designation in the U.K. for DMT-assisted therapy for major depressive disorder
- The company’s Innovation Passport Designation for SPL026, its lead product candidate, provides access to the Innovative Licensing and Access Pathway (ILAP)
- The ILAP accelerates time to market, facilitates patient access to novel treatments and provides a single integrated platform for sustained collaborative work
- Small Pharma is a neuropharmaceutical company specializing in IP-led development of treatments for mental health conditions
- Small Pharma (DMT) is up by 57.14 per cent and is currently trading at $0.55 per share
Small Pharma (DMT) has been granted fast-track designation in the U.K. for DMT-assisted therapy for major depressive disorder.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) granted the company an Innovation Passport Designation for SPL026, its lead product candidate.
The Innovation Passport is a medicine designation that provides access to the Innovative Licensing and Access Pathway (ILAP).
The ILAP accelerates time to market, facilitates patient access to emerging and novel treatments, and provides a single integrated platform for sustained collaborative work among the MHRA, its partners and Small Pharma, which allows for enhanced coordination and monitoring of product development culminating in market authorization.
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.
Dr. Carol Routledge, Chief Medical and Scientific Officer at Small Pharma, said,
“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 from MDD.”
Small Pharma is a neuropharmaceutical company specializing in IP-led development of treatments for mental health conditions.
Small Pharma (DMT) is up by 57.14 per cent and is currently trading at $0.55 per share as of 12:36 pm ET.