Petros Pharmaceuticals Inc. (NASDAQ: PRPI) Conducting Stendra Pilot Study Seeking OTC status from the FDA

Petros Pharmaceuticals Inc. (NASDAQ: PRPI)  has completed a small pilot label comprehension study which is the first step in the process of obtaining an over-the-counter starter for its erectile dysfunction drug, Stendra, from the US FDA.  

Stendra is in the process to receive OTC status

Stendra has FDA approval as an oral phosphodiesterase 5 (PDE5) prescription inhibitor for erectile dysfunction treatment.  Chief commercial officer Fady Boctor said there is an unmet medical need for effective and safe erectile dysfunction treatment. He explained that the OTC status path is an attractive approach even though not all prescription medications are ideal for non-prescription access. 

Boctor added, “Petros has initiated steps, in line with the FDA’s guidelines, to advance expanding product access beyond the prescription designation. Our first Label Comprehension Study demonstrated very promising results and produced highly productive data regarding how the label influences behaviors, and we have already initiated a Phase 2 study, which may ultimately be considered the pivotal study, to continue the FDA-guided pathway toward an application for OTC designation.”. 

Petros reports Q1 2021 results 

Recently the company announced its Q1 2021 results in which its reported 300% YoY growth in Stendra net sales. In addition, the company reported that Stendra tablet [prescriptions were 23% up YoY and 6% QoQ hitting a record high of tablets prescription since the company started marketing Stendra. Gross margins grew 84% in Q1 2021 compared to 56% inQ1 2020. Most importantly, the company had a positive net income of $3 million in the quarter compared to also of $6.1 in Q1 2020.

Boctor said, “Petros’s performance during the first quarter of 2021 significantly outpaced the same period from 2020, a pre-COVID comparator that provides us reason for optimism going into the rest of 202. We believe this, in part, results from our streamlining of internal processes and cost-cutting measures, combined with implementing improved sales and marketing initiatives.”