Awakn Life Sciences has initiated an investigative study to establish the dissociative effect of a proprietary and patent pending formulation of (S)-ketamine and an optimised route of administration to support commercialisation.
The trial’s participants will consist of harmful drinkers, they will be administered 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.
Professor Celia Morgan who is leading the current study and led Awakn’s recent successful phase II b trial, commented: “This study is really exciting for the future of ketamine-assisted therapy in the treatment of alcohol problems. If we find a signal that this new formulation may work in alcohol use disorder then this could open up ketamine-assisted therapy to a much wider range of clinicians, practitioners and patients.
“It may also be useful in rolling out this therapy in other indications. Our previous evidence has shown that ketamine-assisted therapy works in alcohol use disorder, but this is somewhat limited due to the need to give the ketamine intravenously.
“This may then herald the advent of a much more widely available new treatment for people struggling with alcohol problems who are not currently being served by existing treatments.”
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.
Awakn CEO Anthony Tennyson, added: “This is an exciting development for Awakn which we believe will strengthen our innovative pipeline of therapeutics and corresponding IP.
“Critically it also has the potential to improve treatment options and experiences for so many people suffering from Alcohol Use Disorder, with so few effective options available to them, there has never been a greater need.”
