Acerus Pharmaceuticals has announced the initiation of a Phase 1 clinical trial of an intranasal formulation of cannabis oil, which the company said is “a preliminary step in a broader strategy focused on identifying additional applications for Acerus’ proprietary nasal delivery technology, including for prescription medical marijuana.”
The company has developed several formulations of testosterone as a nasal gel, including Natesto intranasal testosterone, which is approved in the US and in Canada.
The PK trial will compare a 5 mg dose of oral cannabis oil to a dose of intranasal cannabis oil in 14 subjects who have previously used cannabis. The study will be conducted in Canada by an unnamed CRO.
Acerus President and CEO Ed Gudaitis commented, “This clinical trial is an important milestone in our previously announced cannabinoid Initiative. Our strategy is to develop a portfolio of THC and cannabidiol-based products that utilize our nasal gel delivery technology for use in a range of potential indications. The company will generate evidence for the use of these products so that we can differentiate our products in the clinical and medical applications of cannabis. If successful, we will look to commercialize these products through partnerships or through our own efforts.”
Acerus Chief Scientific Officer Nathan Bryson said, “Smoking and oral ingestion are not optimal routes for cannabinoid administration, especially for medical marijuana users. The nasal route of administration not only avoids first pass metabolism, it offers precise and consistent dosing, convenience and efficiency; benefits which may also apply to the delivery of THC. The unique clinical benefits of our proprietary nasal platform are gaining awareness and acceptance among patients and physicians, who are currently using Natesto to treat hypogonadism.”
Read the Acerus Pharmaceuticals press release.
