ZolpiMist Launches into the $1.8 billion U.S. Non-Benzodiazepine Prescription Sleep Aid Market

ENGLEWOOD, CO / ACCESSWIRE / August 13, 2018 / Aytu BioScience, Inc. (NASDAQ: AYTU), a specialty pharmaceutical company focused on global commercialization of novel products addressing significant medical needs, today announced the accelerated launch of ZolpiMist™, an oral spray formulation of zolpidem tartrate (brand name Ambien®) and the only FDA-approved oral spray prescription sleep aid.

The Aytu BioScience sales force begins promoting ZolpiMist to U.S. clinicians today in the domestic $1.8 billion non-benzodiazepine prescription sleep aid market. The earlier than expected launch of ZolpiMist was made possible by the company taking early delivery of an initial supply of commercial ZolpiMist inventory.

Josh Disbrow, Aytu BioScience Chief Executive Officer stated, "We are pleased to be launching ZolpiMist this week ahead of schedule, following the signing of our exclusive license agreement just two months ago. Our sales force has completed a rigorous training program, and initial inventory has been purchased and received. Additionally, U.S. wholesalers have been stocked, and now we are well positioned to effectively promote ZolpiMist alongside Natesto, our FDA-approved nasally-administered testosterone replacement therapy. ZolpiMist is a novel product, offering distinct benefits to patients with short-term insomnia, and we look forward to introducing ZolpiMist to the U.S. market."

For the twelve months ending December 31, 2017, there were over 43 million prescriptions of non-benzodiazepine sleep aids prescribed in the U.S., representing sales of $1.8 billion. Zolpidem tartrate is the most commonly prescribed sleep aid, with more than 30 million prescriptions of various forms of zolpidem tartrate prescribed annually in the U.S.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on global commercialization of novel products addressing significant medical needs. The company currently markets Natesto®, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"). 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 of the U.S. where it is a CE Marked, Health Canada cleared, Australian TGA approved, Mexican COFEPRAS approved product, and Aytu is planning U.S.-based clinical trials in pursuit of 510k de novo medical device clearance by the FDA. Aytu recently acquired exclusive U.S. and Canadian rights to ZolpiMist™, an FDA-approved, commercial-stage prescription sleep aid indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large, growing markets. For more information visit aytubio.com.

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SOURCE: Aytu BioScience, Inc.