NovaDel Pharma, a developer of oral spray formulations, has presented pharmacokinetic (PK) and safety results from its pilot PK study comparing Duromist to Viagra.
Duromist and Viagra are NovaDel’s oral spray and tablet formulations of sildenafil citrate, a drug indicated for the management of pulmonary hypertension and erectile dysfunction developed and marketed by Pfizer.
NovaDel plans to review the results from the study with the FDA to obtain guidance on defining definitive clinical trial requirements as a pathway to NDA approval.
The pilot PK study was designed primarily to assess the relative bioavailability of one, two and three doses of 10 mg/0.12ml of Duromist, compared to that of the 25mg Viagra tablet in healthy adult male subjects.
The secondary objective was to assess the relative safety of Duromist following single oral dose administration compared to that of 25mg Viagra tablets.
According to the study results, Duromist has demonstrated a safety profile and was well tolerated in this pilot PK study, including evaluation of changes in orthostatic hypotension, oral irritation, vital sign and electrocardiogram assessments.