Bioavailability and uptake, but not "faster onset"
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DuroMist™ has been evaluated in a pilot pharmacokinetic (PK) clinical trial comparing the lingual spray to oral *word disallowed by google (Viagra®). The trial was designed to assess the relative bioavailability and safety of one, two and three sprays of 10mg/0.12ml of DuroMist™, compared to a 25mg Viagra® tablet. It was a single-centre, open-label, single-dose, randomised, four-period, four-treatment, crossover study under fasting conditions. There were 24 healthy adult male subjects enrolled in the study.
The results from the trial successfully demonstrated that the 20mg dose (two sprays) of DuroMist™ was bioequivalent to the 25mg Viagra® tablet with respect to systemic exposure. The mean systemic exposure with the 10mg dose (one spray) was approximately 40% of the 25mg Viagra tablet, as expected; and the 30mg dose (three sprays) was approximately 40% higher than the 25mg Viagra® tablet, which was about 20% higher than expected.
These data suggest that DuroMist™, as compared to the Viagra® tablet, provides effective absorption of *word disallowed by google via the oral transmucosal route. Furthermore, DuroMist™ demonstrated an excellent safety profile and was well tolerated in the PK study at all dose levels.
The US FDA accepted an Investigational New Drug (IND) application following a successful pre-IND meeting to discuss the clinical plan for registration. In 2014, SUDA commenced formulation work on a second-generation version of DuroMist™, which has vanilla and peppermint flavouring, together with absorption enhancers to quicken the onset of action. Stability studies on the new formulation are underway, prior to further dialogue with the FDA.
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