TORONTO--(BUSINESS WIRE)--Acerus Pharmaceuticals Corporation (TSX:ASP) today announced that an abstract highlighting the therapeutic potential of NATESTO™, a novel testosterone nasal gel, will be featured at the 71st Annual Canadian Urological Association Meeting in Vancouver, British Columbia on Monday, June 27th, 2016.
The abstract, entitled “Novel Nasal Gel Restores Testosterone Levels in Hypogonadal Men with Seasonal Allergies,” will be presented by Alan D. Rogol, MD, Ph.D. Professor, Emeritus at the University of Virginia.
“We are very excited to officially introduce NATESTO™ to Canadian urologists and other healthcare practitioners at the upcoming Canadian Urological Association Meeting,” said Tom Rossi, President and Chief Executive Officer of Acerus. “Our participation at the meeting signifies the first of many steps we will take in building our partnership and presence within the urology community in Canada. We look forward to making this innovative product available to Canadian men with low testosterone within the next months.”
The abstract summarizes the efficacy results seen in patients with seasonal allergies who were included in clinical studies supporting the approval of NATESTO™ in the U.S. and Canada. The Phase 1 pharmacokinetic study demonstrated that the absorption and efficacy of NATESTO™ testosterone nasal gel is maintained even when patients with seasonal allergies (rhinitis) are forcibly challenged with pollen from Dactylis glomerata. The concomitant use of a decongestant (oxymetazoline) after the pollen challenge did not modify the absorption of testosterone. In the pivotal Phase 3 study, only three out of a total of 52 subjects with seasonal allergies and treated with NATESTO™ for six months or more, reported seasonal allergic flare-ups. The surprisingly low incidence of seasonal allergies in the Phase 3 study is believed to reflect the unique formulation, which includes a natural oil that may create a fine protective barrier to reduce the direct contact of air-born allergens with the nasal mucosa and thereby reduce allergy flare-up.
NATESTO™ was approved by Health Canada in January 2016 for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). Commercial availability of NATESTO™ in Canada is expected in the third quarter of this year.
For more information about NATESTO™, please consult the Product Monograph at: http://s2.q4cdn.com/417379002/files/doc_downloads/NATESTO-PM-December-30-2015.pdf.
Acerus Pharmaceuticals Corporation is a Canadian pharmaceutical company focused on the development, manufacture, marketing and distribution of innovative, branded products that improve the patient experience.
Acerus markets ESTRACE® in Canada, a product indicated for the symptomatic relief of menopausal symptoms. NATESTO™, a product utilizing an Acerus licensed nasal gel technology, is the first and only testosterone nasal gel approved in Canada, and available in the United States for replacement therapy in adult males diagnosed with hypogonadism. GYNOFLOR™, a product licensed to Acerus in Canada by Medinova AG and approved in 39 countries worldwide, is an ultra-low dose vaginal estrogen therapy with the addition of lactobacillus, for the treatment of atrophic vaginitis, certain vaginal infections and/or to restore a healthy vaginal environment. TEFINA™, a ‘use as required’ nasal testosterone gel, is an Acerus drug development candidate aimed at addressing a significant unmet need for women with female sexual dysfunction.
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 performance of NATESTO™, 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 1, 2016 that 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.