Acerus Announces Results of Phase 1 Clinical Trial with a Proprietary Intranasal Formulation of a Tetrahydrocannabinol-Rich Cannabis Oil
Acerus Pharmaceuticals Corporation (TSX:ASP) (“Acerus” or the “Company”) is today providing results of a Phase 1 clinical trial (the “trial”) testing a proprietary intranasal formulation of a tetrahydrocannabinol (“THC”)-rich cannabis oil in healthy volunteers.
The THC trial, previously announced on October 24, 2018, involved 12 overnight-fasting, healthy subjects with prior cannabis experience. Each subject randomly received one 5mg dose of cannabis oil orally and an equivalent dose of cannabis oil nasally delivered through our proprietary intranasal formulation, with at least one week separating the two treatments.
Blood levels were measured and pharmacokinetic parameters of absorption and elimination were determined along with the comparative bioavailability of THC for the two routes of administration. Self-reported subject outcomes were also collected.
- The nasal formulation was absorbed and resulted in extended PK profile with maximum peak levels (Tmax) occurring 7h after administration, on average;
- Bioavailability of THC from the nasal formulation was approximately 2.2 times better than oral dronabinol capsules as described in recent literature (see Oh et al., Clinical Pharmacology: Advances and Applications 2017, 9, 9);
- Additionally, a majority of subjects reported appreciation of several key features of the nasal product, including quick/easy use, consistent dosing, portability and absence of smoke.
“We are encouraged by the results of our Phase 1 study,” said Ed Gudaitis, President and CEO of Acerus Pharmaceuticals. “We believe that the adaptation of our proprietary nasal delivery system for cannabinoids validates our approach to developing safer, discreet and convenient cannabis products for the medical cannabis sector. Our goal is to develop a portfolio of cannabis products having THC and CBD in their compositions, in order to address a broad set of conditions. These products can be commercialized either through partnerships or through our own efforts.”
Acerus Pharmaceuticals Corporation is a Canadian-based specialty pharmaceutical company focused on the development, manufacture, marketing and distribution of innovative, branded products that improve patient experience, with a primary focus in the field of men’s and women’s health. The Company commercializes its products via its own salesforce in Canada, and through a global network of licensed distributors in the U.S. and other territories.
Notice Regarding Forward-Looking Statements
Information in this press release that is not current or historical factual information may constitute forward looking information within the meaning of securities laws. Implicit in this information are assumptions regarding our future operational results. These assumptions, although considered reasonable by the company at the time of preparation, may prove to be incorrect. Readers are cautioned that actual performance of the company is subject to a number of risks and uncertainties, including with respect to the potential commercial viability of products generated through its cannabinoids initiative or the eventual results of R&D initiatives, and could differ materially from what is currently expected as set out above. For more exhaustive information on these risks and uncertainties you should refer to our annual information form dated March 20, 2018 which is available at www.sedar.com. Forward-looking information contained in this press release is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time, whether as a result of new information, future events or otherwise, except as required by applicable securities law.
President and CEO
Acerus Pharmaceuticals Corporation