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Aytu BioScience, Inc. (NasdaqCM: AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, hit another potential home run for one of its pipeline products – this time it’s for ZolpiMist™. In a release earlier this week, AYTU announced the publication of a clinical study in the journal Pharmacy and Pharmacology, demonstrating that ZolpiMist™, Aytu BioScience’s lingual spray formulation of zolpidem, achieves sleep onset more quickly than the oral tablet form of zolpidem (brand name Ambien®) in patients seeking short-term treatment for insomnia.

The news comes after both Natesto® and MiOXSYS® generated their own attention-getting headlines where new data is proving their superiority over competing products. The newest scientific report for the promising sleep-aid drug describes a post-hoc analysis of data from the pivotal Phase 3 study of ZolpiMist™. According to data published, the four-arm crossover study compares 5 and 10 mg doses of the lingual spray (LS) and tablet formulations of zolpidem in 43 adults (N = 20 males, 23 females). The generally accepted blood serum therapeutic threshold for zolpidem in treatment of insomnia is a blood plasma concentration of 20 ng/mL. The results showed that, on average, ZolpiMist™ achieved this threshold more quickly than tablet zolpidem, with the lingual spray (ZolpiMist™) formulation achieving this threshold at 7.0 and 10.5 minutes, for the 10 mg and 5 mg doses, respectively. In comparison, the tablet zolpidem achieved this threshold at 15.0 and 17.2 minutes, for the 10 mg and 5 mg doses, respectively.

Moreover, an additional measure to quantify sedation that was utilized in this study was the Digit Symbol Substitution Test (DSST), which is an assessment of attention, perceptual speed, motor speed, visual scanning and memory. Also showing best-in-class performance in comparison, the average time to achieve a 5-point change (from baseline) in DSST for ZolpiMist™ was 4.8 minutes and 8.0 minutes, for the 10 mg and 5 mg doses, respectively. Conversely, for tablet zolpidem, the time to achieve a 5-point change (from baseline) in DSST was 14.0 minutes and 16.2 minutes, for the 10 mg and 5 mg doses, respectively.

Video Link: http://www.youtube.com/embed/SUQ1zh781p0

ZolpiMist™ Is An Emerging Sleep-Aid Leader

The data demonstrate that ZolpiMist™ may be on its way to becoming a sleep-aid drug leader, with the analyses helping to illustrate the differences in administration modality and absorption of two formulations of zolpidem tartrate. In particular, comparisons show that the oral tablet formulation is relatively slow compared to the lingual spray and subjects a drug to a first-pass metabolism effect, making bioavailability generally lower and slower comparatively. Taking into account each of the data points, the studies demonstrate that ZolpiMist™ lingual spray may enable a more than two-fold faster onset of sedation over zolpidem tablets.

The new study data follows two other important developments for ZolpiMist™. In March, AYTU announced a licensing deal with SUDA Pharmaceuticals that allows SUDA to lead commercial development and sublicensing efforts for ZolpiMist™ in major territories outside the United States and Canada, including Europe, Asia, Australia, and Latin America. The deal also calls for SUDA to pay Aytu a portion of each sale upfront as well as negotiated milestone payments received from sub-licensees. In addition, AYTU will receive ongoing royalty payments on sales generated by SUDA’s sublicensees as ZolpiMist™ is launched in their respective territories.

Then, in April, AYTU announced that they have completed the submission of ZolpiMist™ (zolpidem tartrate oral spray) for regulatory approval to the Australian Therapeutic Goods Administration (TGA) and that SUDA Pharmaceuticals, who filed the submission and holds the global license to ZolpiMist™™ outside of the U.S. and Canada, disclosed that the TGA has accepted the ZolpiMist™ Marketing Authorization Application (MAA) and has initiated its review process. Currently, ZolpiMist™ is the only FDA-approved oral spray formulation of zolpidem tartrate, the active ingredient marketed in the U.S. under the brand name Ambien®.

Huge Opportunity In A Potential $50 Billion Market

The AYTU pipeline is strong and each of its products have been providing the markets with encouraging data. For ZolpiMist™, though, the most recent Journal inclusion supports the opportunity for a combined AYTU and SUDA to take advantage of the proven benefits of ZolpiMist™ and target to a global sleep aid market that is currently estimated to generate roughly $50 billion in annual revenue.

And, with the market expected to surge to a more than $80 billion potential by 2022, the ZolpiMist™ profile may help AYTU to earn a sizable portion of the sleep-aid drug market. Moreover, with AYTU now able to claim potential superiority for Natesto, MiOXSYS, Tuzistra XR, and ZolpiMist™ when compared against its competing drugs… AYTU may be about as well positioned for growth than at anytime during its company history.

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