Tuesday August 13, 2019 0 comments
ENGLEWOOD -- Aytu BioScience, Inc. (NASDAQ:AYTU) announced 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 new report describes a post-hoc analysis of data from the pivotal Phase 3 study of ZolpiMist. 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.
On average, ZolpiMist achieved this threshold more quickly than tablet zolpidem, Aytu said. The lingual spray (ZolpiMist) formulation achieved this threshold at 7.0 and 10.5 minutes, for the 10 mg and 5 mg doses, respectively.
Tablet zolpidem achieved this threshold at 15.0 and 17.2 minutes, for the 10 mg and 5 mg doses, respectively.
Aytu said an additional measure to quantify sedation that was utilized in the study was the Digit Symbol Substitution Test (DSST), which is an assessment of attention, perceptual speed, motor speed, visual scanning and memory.
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.
Aytu said these analyses help illustrate the differences in administration modality and absorption of two formulations of zolpidem tartrate. The oral tablet formulation is relatively slow compared to the lingual spray and subjects a drug to a first-pass metabolism effect.
Thus, bioavailability is generally low and slow comparatively. This, in turn, results in ZolpiMist lingual spray enabling a more than two-fold faster onset of sedation over zolpidem tablets.
“We are pleased with the reported results of this new analysis that demonstrate a more rapid onset of sleep and increased bioavailability of ZolpiMist when compared to zolpidem tablets,” said Josh Disbrow, Aytu’s CEO.
“The novel oral spray form embodied in ZolpiMist may present patients with a more convenient form and a simple way to achieve rapid sleep onset. For the first time this study has established the clinical proof demonstrating fast sleep onset and the distinct pharmacokinetics of ZolpiMist that support its use in the short-term treatment of insomnia.”