Awakn Life Sciences Corp. announces it has initiated an investigative study to establish the dissociative effect of a proprietary and patent pending formulation of (S)-ketamine and optimized route of administration to support commercialization in due course. Today's news builds on Awakn's announcement in August 2022 of a twelve-month option agreement wit a leading drug development, manufacturing, and delivery systems company to in-license a proprietary formulation of (S)-ketamine with an optimized route of administration.

The trial's participants will consist of harmful drinkers, they will be administered with a dose of (S)-ketamine delivered via a proprietary oral thin film formulation. The study will evaluate the dissociative effect garnered from the formulation and look at alcohol cravings from participants. The study will also assess mechanistic factors including electroencephalographic (EEG) markers of increased neuroplasticity.

If the results of this study are positive, it will potentially lead to a global licensing agreement for phase I data of the patent pending oral thin film (S)-ketamine formulation. This could result in Awakn advancing to a larger phase II b study and having global exclusivity rights to use the thin film formulation in the treatment of all addictions. The mass adoption of intravenous delivered ketamine-assisted therapy may be limited due to the requirement for specific infrastructure and clinicians to administer it.

This emphasises the need for a novel route of administration.