TORONTO--(BUSINESS WIRE)--Acerus Pharmaceuticals Corporation (TSX:ASP) announces the acceptance of two posters highlighting the clinical benefits of NATESTO® for presentation at the Endocrine Society 2017 Annual Meeting (ENDO) to be held on April 1-4, 2017 in Orlando, Florida. Both abstracts will also be published in future issues of Endocrine Reviews. Developed by Acerus, NATESTO® is the first and only testosterone nasal gel available in Canada and the US indicated for androgen replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism).1
“The acceptance of these posters, in addition to the two abstracts accepted for presentation at the American Urology Association Annual Meeting announced last month, further expands the body of evidence in support of NATESTO®,” said Tom Rossi, Chief Executive Officer of Acerus Pharmaceutical Corporation.
The following summarizes the two abstracts accepted for presentation at ENDO:
Title: Seasonal Allergies Do Not Significantly Impact the
Absorption of NATESTO® (Testosterone) Nasal Gel in
Presenter: Alan Rogol, MD, PhD, Professor, University of Virginia, Charlottesville, VA
Conclusions: The pharmacokinetics, safety and efficacy of NATESTO® for restoring normal testosterone levels in men with Low T is not adversely affected by seasonal allergies.
Title: One-Year Hematologic Safety of NATESTO®
(Testosterone) Nasal Gel in Men with Hypogonadism
Presenter: Margaux Guidry, Ph.D. and Gerwin Westfield, Ph.D., both Aytu Bioscience, Englewood, CO
Conclusions: Treatment with NATESTO® helped hypogonadal men achieve normal testosterone levels, while on average keeping hematologic levels, particularly hematocrit, well within the normal range.
About NATESTO® (Testosterone) Nasal Gel
NATESTO® is a testosterone nasal gel developed by Acerus Pharmaceutical Corporation and indicated as a replacement therapy for men diagnosed with conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). It is the first and only nasally-administered testosterone product approved by the U.S. FDA and Health Canada, and available in a ‘no-touch’ dispenser with a metered dose pump for reduced transference risk. The recommended starting dose of NATESTO® in Canada is 11 mg of testosterone (one actuation per nostril) administered twice daily for a total daily dose of 22 mg. A copy of the NATESTO® product monograph can be found at: http://www.aceruspharma.com/English/products-and-pipeline/NATESTO®/default.aspx.
For further information, specific to the U.S. product dosing and administration, please visit: www.NATESTO®.com.
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 currently markets two products in Canada: ESTRACE®, a product indicated for the symptomatic relief of menopausal symptoms; and NATESTO®, the first and only testosterone nasal gel for testosterone replacement therapy in adult males diagnosed with hypogonadism. Acerus’ pipeline includes two new innovative products: GYNOFLOR™, an ultra-low dose vaginal estrogen combined with a probiotic, used in the treatment of atrophic vaginitis, restoration of vaginal flora and treatment of certain vaginal infections; and TEFINA™, a ‘use as required’ 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, 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.
1. NATESTO® Product Monograph, October 25, 2016 and Rogol et al. J Andrology 2015, 4(1), 46