The FDA was supportive of a single dose bioequivalent study comparing Aspargo’s Sildenafil Oral Spray, an oral liquid suspension formulation of sildenafil citrate, with Viagra tablets and deemed the 505(b)(2) regulatory pathway appropriate for the program.
“We are encouraged by the outcome of the pre-IND meeting with the FDA and based on their feedback are advancing towards an IND submission for Sildenafil Oral Spray in the third quarter of 2020,” said Michael Demurjian, CEO of Aspargo. “Importantly, the FDA deemed the 505(b)(2) regulatory pathway appropriate for our clinical program and pending results from our planned single-dose bioequivalent study, we do not foresee the need to conduct any additional long-term safety, toxicology or phase 3 efficacy studies. We look forward to advancing Sildenafil Oral Spray in the U.S. market to provide men who suffer from erectile dysfunction a differentiated dosing formulation that provides convenient administration, flexible dosing and access for ED patients who have difficulty swallowing oral tablets.”
In its written response, the FDA supported Aspargo’s plan to conduct a single dose bioequivalent study to evaluate the pharmacokinetics, bioequivalency, tolerability and safety of the company’s Sildenafil Oral Spray drug candidate, administered via a metered dose pump or individual single liquid unit, when compared to Viagra tablets. The randomized, single center, unblinded, three-way crossover study will seek to enroll a total of 72 healthy volunteers who will receive a single dose of Sildenafil Oral Spray administered via a dose metered pump, a single dose of Sildenafil Oral Spray administered via an individual single liquid unit or a single dose of Viagra oral tablet. Thirty-six subjects will be treated under fed conditions and thirty-six subjects will be treated under fasting conditions.
The FDA did not object to the planned study design and patient populations, as well as plans for manufacturing and product testing, and did not recommend any additional studies in preparation for an IND submission and initiation of clinical trials.
Aspargo is collaborating with Pharmaceutics International Inc. (Pii), a CDMO located in Hunt Valley, MD, to develop and manufacture Sildenafil Oral Spray for clinical trials. Pii is also laying the groundwork for the future commercial manufacturing requirements of Sildenafil Oral Spray in the U.S.