TORONTO--(BUSINESS WIRE)--Acerus Pharmaceuticals Corporation (TSX:ASP) announces that two abstracts highlighting the clinical benefits of NATESTO® were accepted for presentation at the American Urological Association’s (AUA) 2017 Annual Meeting, to be held May 12-16 in Boston. 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
Tom Rossi, Chief Executive Officer of Acerus Pharmaceutical Corporation, said: “Studies, including the two accepted for presentation at the upcoming AUA, provide further scientific evidence of the safety and efficacy of NATESTO®, and the unique benefits of a nasally administered testosterone replacement therapy. We are very pleased to see that NATESTO® continues to capture the attention of the scientific community and would like to thank our partners, Aytu BioScience, for developing these abstracts and for their commitment in building the clinical evidence in support of NATESTO®.”
The following summarizes the two abstracts accepted for presentation at the AUA’s 2017 Annual Meeting:
Title: Clinical Improvements in Erectile Function and Mood in
Hypogonadal Men Treated with 4.5% Nasal Testosterone Gel
Abstract #: 17-6376
Presenter: Larry I. Lipshultz, MD, Professor of Urology and Chief of the Scott Department of the Urology's Division of Male Reproductive Medicine and Surgery, Baylor College of Medicine, Houston, TX
Conclusions: NATESTO® achieves large, clinical improvements in erectile function, mood and sexual desire within 30 days of initiating treatment.
Title: Preservation of Normal Concentrations of Pituitary Gonadotropins
Despite Achievement of Normal Serum Testosterone Levels in Hypogonadal
Men Treated with a 4.5% Nasal Testosterone Gel
Abstract ID: 17-6558
Presenter: William Conners, MD, Urologist at Men's Health Boston and Clinical Instructor of Urology at Harvard Medical School, Boston, MA
Conclusions: Treatment with NATESTO® restores serum total testosterone to normal levels in hypogonadal men, while also mitigating the decline in luteinizing hormone (LH) and follicle-stimulating hormone (FSH) which remained within the normal range at Day 90 of treatment.
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, December 30, 2015 and Rogol et al. J Andrology 2015, 4(1), 46