Englewood, CO – April 4, 2017 – Aytu BioScience, Inc. (OTCQX: AYTU), a specialty pharmaceutical company focused on global commercialization of novel products in the field of urology, today announced that it presented two posters demonstrating the safety advantages of Natesto® testosterone nasal gel, including the one-year hematologic safety and tolerability among men with seasonal allergies, in men with hypogonadism.
Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated, “Clinical and scientific data presentations continue to demonstrate Natesto’s unique attributes including the safety profile of Natesto as indicated by the product’s nominal impact on hematocrit levels after long-term use as well as the lack of allergy symptoms observed in men with seasonal allergies who were taking Natesto for a sustained period. Natesto’s unique dosing and administration, as the only FDA-approved nasally-administered testosterone replacement therapy, result in a distinct efficacy and safety profile. As such we look forward to sharing additional clinical data as we, along with our clinical collaborators, continue to explore various aspects of Natesto’s safety and efficacy.”
The posters presented at ENDO 2017 were as follows:
Title: One-Year Hematologic Safety of Natesto (testosterone) Nasal Gel in Men with Hypogonadism
Poster Number: SAT-126
Presenter: Margaux Guidry, PhD, Medical Affairs, Aytu BioScience
Conclusion: Natesto allows men to achieve serum total T levels in the normal range while not increasing hematologic values above the normal range. A potential inference for the distinctive efficacy and safety profile of Natesto is the unique dosing and administration.
Title: Seasonal allergies do not significantly impact the absorption of Natesto (testosterone) nasal gel, in hypogonadal men
Poster Number: SAT-126
Presenter: Alan Rogol, MD, PhD, University of Virginia, Charlottesville, VA
Conclusion: Efficacy was similar for allergic rhinitis patients and non- allergic rhinitis patients. Most surprising was the very low incidence of seasonal allergy symptoms reported by susceptible patients while on treatment for ≥6 months. Only 3/52 (5.8%) of these patients with ≥6 months exposure reported seasonal allergy flare-up.
Selection of the abstracts for publication in the press programme does not imply endorsement of the Natesto by ENDO®.
About Aytu BioScience, Inc.
Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on global commercialization of novel products in the field of urology. The company currently markets two products in the U.S.: Natesto®, the first and only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or “Low T”) and ProstaScint® (capromab pendetide), the only FDA-approved imaging agent specific to prostate specific membrane antigen (PSMA) for prostate cancer detection and staging. Additionally, Aytu is developing MiOXSYS®, a novel, rapid semen analysis system with the potential to become a standard of care for the diagnosis and management of male infertility caused by oxidative stress. MiOXSYS is commercialized outside the U.S. where it is a CE Marked, Health Canada cleared product, and Aytu is conducting U.S.-based clinical trials in pursuit of 510k medical device clearance by the FDA. Aytu’s strategy is to continue building its portfolio of revenue-generating urology products, leveraging its focused commercial team and expertise to build leading brands within well-established markets. For more information visit aytubio.com.
Forward Looking Statement
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