(065) A Randomized, Single-Dose, Bioavailability and Safety Study on Novel SDS-089 Nasal Vardenafil 4mg Spray Solution in Comparison to Oral Vardenafil Tablet 10 mg in Healthy Volunteers

Abstract Introduction Oral phosphodiesterase type 5 inhibitor (PDE5i) is recognized as an effective first-line medical therapy for males with erectile dysfunction. However, oral PDE5i drug adherence and satisfaction rates were not high due to the need for oral ingestion, lack of sexual spontaneity, and delay in time to clinical effect. Hence, a nasal delivery of PDE5i drug may circumvent these limitations. Objective To assess the bioavailability and safety profile of SDS-089 nasal Vardenafil spray compared to oral Vardenafil 10mg tablet. Methods Following approval from Institutional Review Board and Biosafety Committee (FB18/IRB/099), 13 subjects out of the 32 healthy volunteers met the study criteria and were randomized to receive SDS-089 nasal Vardenafil spray (4 mg) or oral Vardenafil tablet (10 mg). The vardenafil HCl formulation SDS-089 was prepared with the active pharmaceutical ingredient meeting the United States Pharmacopeia (USP) standard (batch 1704002361). Blood tests were conducted on the subjects to evaluate Vardenafil drug bioavailability and treatment-related adverse events (TRAEs) data was collected. Results All 13 subjects completed the study. Based on the drug pharmacokinetics data, SDS-089 nasal spray was shown to have a faster onset and achieve optimal dose with a lower amount of drug compared to oral formulation. Of the 42 recorded TRAEs, 33 TRAEs were associated with the nasal spray, and 9 TRAEs were related to oral drugs. Transient headache is the most common TRAE in the nasal group and was very tolerable. The reported headaches showed no relationship with Cmax (peak concentration) and AUC0-inf (the total drug exposure across time) based on the Vardenafil drug levels. Conclusions SDS-089 nasal spray formulation Vardenafil HCl at 4 mg successfully achieved a similar Cmax with that of oral Vardenafil 10 mg tablet, and while it appeared to have more TRAEs, these were transient and well-tolerated by the subjects. Disclosure Yes, this is sponsored by industry/sponsor: LTR Pharma. Clarification: Industry funding only - investigator initiated and executed study.