As competence grows, biopharmaceuticals are searching for ways to present their specific psychedelic substance-assisted therapies in a way that might differentiate them from their competitors while maintaining safety and efficiency standards.
In this sense, Awakn Life Sciences Corp. AWKNF, the biotech firm aiming to tackle addictions, has signed a development agreement with Catalent, a global company aiding biopharma, cell, gene, and consumer health partners to optimize the development, launch and supply of treatments across multiple modalities.
The agreement is set to investigate a market-ready proprietary formulation and optimized delivery route for Awakn’s MDMA using Catalent's Zydis orally-disintegrating tablet (ODT) technology, a freeze-dried dosage form that rapidly disperses in the mouth and therefore holding the potential to deliver a faster onset of the drug’s effects.
Awakn will test Zydis technology in its ongoing Phase 2 MDMA-assisted therapy clinical trials for substance and behavioral addictions as well as other mental health disorders such as anxiety, depression, PTSD and eating disorders.
Awakn’s CEO Anthony Tennyson said the agreement “further strengthens the IP moat for our MDMA program.”
“Having the right partner to help facilitate our upcoming Phase IIb clinical trial is key, but it also provides a defined pathway towards regulatory approval, which is the goal of the program. With such a large cohort of people globally suffering with AUD and a current standard of care that lacks long-term efficacy, a new more effective treatment has never been more needed," Tennyson said.
On behalf of Catalent, its president Tom Hawkeswood said: "Catalent has a proven track record of working with partners to develop, launch and supply new therapies that are differentiated from traditional and generic dose forms, and that are difficult to emulate. Because it dissolves almost instantly in the mouth, Zydis technology provides multiple potential benefits including initial acceptance, adherence, convenience, and advantages for products where a rapid onset of action is possible."
Photo courtesy of Yuriy Golub and Bacsica on Shutterstock.
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