Awakn Life Sciences Corp. AWKNF, a biotech company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), has been granted an Innovation Passport for its proprietary Ketamine-Assisted Therapy (KAT) to treat severe AUD. The passport was granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
See also: Can Ketamine Treat Alcohol Addiction? The Awakn Approach
The designation is part of the Innovative Licensing and Access Pathway (ILAP), which aims to accelerate time-to-market and facilitate patient access.
Similar to the FDA's fast-track program, the MHRA Innovation Passport gives Awakn access to specialist advice from the MHRA and its partners including the National Institute of Health and Care Excellence (NICE).
See also: PharmaTher Holdings Nabs New Orphan Drug Status, Discusses Further Fast-Track, Partners For MDMA Patch
The program could ultimately authorize the National Health Service (NHS) to adopt potential treatments faster and enable quicker patient access.
The company’s head of KAT professor Celia Morgan pointed out that the Innovation Passport status will enable Awakn “to build optimally” on the Phase 2 proof-of-concept study results while working in partnership towards marketing authorization.
“We look forward to working closely with the MHRA, NICE and partners to accelerate our planned Phase 3 clinical trial, to be undertaken in collaboration with the NIHR, MRC, NHS, and Exeter University," Morgan said.
Photo: Benzinga edit with photo by qimono on Pixabay and Doc James on Wikimedia Commons.
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