Petros Pharmaceuticals Inc.

07/13/2021 | Press release | Distributed by Public on 07/14/2021 08:46

Petros Pharmaceuticals Completes Pilot Label Comprehension Study to Initiate Process for Stendra® Prescription Erectile Dysfunction Medication to Achieve Designation as an[...]

New York - July 13, 2021 - Petros Pharmaceuticals, Inc. (Nasdaq: PTPI) ('Petros,' or 'the Company'), a leading provider of therapeutics for men's health, today announced it has completed a small label comprehension pilot study, the first step in a process to obtain over-the-counter (OTC) status from the U.S. Food and Drug Administration (FDA) for its erectile dysfunction (ED) medication, Stendra®.

Stendra (avanafil), is an FDA-approved, prescription oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of ED

'There is clearly an unmet need for increased availability of safe and effective ED medications,' said Fady Boctor, Petros President and Chief Commercial Officer. 'Pursuing the pathway toward over-the-counter status is an attractive approach. While not every prescription product is appropriate for non-prescription access, 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.

'Currently, there are no prescription-grade oral ED therapies that have been approved for OTC status in the U.S.,' Mr. Boctor added. 'If approved for OTC status by the FDA, Stendra would be among the first oral ED therapies to gain such a designation. Our mission at Petros Pharmaceuticals remains resolute: we aim to enhance access, affordability, and accommodation to meet the consumer at their preferred point of care. We are optimistic following these initial early results and will continue to work closely with and follow the guidance of the FDA to ensure effective label communication and take each additional mandated step to achieve the OTC designation.'

The Label Comprehension Study evaluated the understanding of 31 subjects who read a draft over-the-counter drug facts label for an erectile dysfunction drug. In the study, a promising 90% or more of the subjects provided either a correct or acceptable response to 19 of the 22 label messages within the study. The Company has initiated a Phase 2 follow-on to this initial study, which is a more significant and larger Label Comprehension Study that will include low health literacy individuals as part of a multi-step process to develop the necessary behavioral study evidence for the FDA to evaluate Stendra for possible OTC designation. This Phase 2 study may potentially serve as a pivotal study, based on outcomes and other factors.

It is estimated that over 30 million men in the U.S. suffer from erectile dysfunction (ED) and despite more than 20 years since prescription solutions first became available, roughly 3 out of every 4 sufferers remain untreated. The burden of suffering for men and couples can be devastating, and for many the hurdles to gain access to reliable solutions from a physician can be equally challenging.