Specialty pharmaceutical company Aytu BioScience Inc has exclusively licensed Zolpimist (zolpidem tartrate oral spray) in the United States and Canada. The company states that the addition of Zolpimist will complement ongoing Natesto selling efforts among primary care physicians and add another revenue-generating product to the company’s portfolio.
Zolpimist is an FDA-approved, proprietary, oral spray formulation of zolpidem tartrate and is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
Josh Disbrow, Aytu BioScience’s CEO, says in a release, “We continue to be pleased with the ongoing launch of Natesto in the US via the company’s direct sales force and the momentum we have achieved through our recently launched Natesto Support Program. We are now excited to add another approved product to our portfolio. Given the substantial overlap in prescribers of testosterone replacement therapies, and Natesto in particular, and anti-insomnia treatments, we believe that this acquisition enables the company to efficiently expand its product portfolio and market both Natesto and Zolpimist to the primary care physicians we already call on. Our prescribers have embraced the novel nasal delivery of Natesto for the treatment of hypogonadism, and likewise, we believe that Zolpimist’s uniquely-delivered oral spray will present a unique, complementary clinical story in a similarly large, adjacent therapeutic category. We look forward to launching Zolpimist while continuing to drive adoption of Natesto in the US”
For the twelve months ending February 2018, there were over 43 million prescriptions of non-benzodiazepine sleep aids written in the United States, and zolpidem tartrate (brand name Ambien) was the most commonly prescribed sleep aid, according to Symphony Health PHAST Prescription Monthly. Non-Benzo Sleep Aid Class TRxs; Current 12 Months Ending February 2018, which also states that more than 30 million prescriptions of various forms of zolpidem tartrate are prescribed annually in the United States.
Zolpimist’s oral spray formulation enables high bioavailability via rapid absorption through the oral mucosa and no first-pass metabolism through the liver, resulting in a rapid onset of sleep.
The company is planning to launch Zolpimist later this calendar year via its direct sales force, calling on the overlapping prescribers of both testosterone replacement therapies and insomnia treatments. Over 50% of current Natesto prescribers are primary care clinicians and significant prescribers of sleep aids, so the company expects to synergize sales efforts by promoting two products to these same physician targets.
Disbrow says, “We believe Zolpimist will serve a large need in insomnia, which affects up to 30% of Americans, while giving our sales representatives another novel product to sell to their primary care physicians. We thank licensor Magna Pharmaceuticals for selecting Aytu BioScience to commercialize Zolpimist and look forward to working with Magna as we build awareness and grow prescription demand for this important, novel product.”
Additional details of the exclusive licensing agreement are available via an 8-K that was filed with the Securities Exchange Commission on June 13, 2018.