Petros Pharmaceuticals Announces Positive Over-the-Counter (OTC) Label Comprehension Study Results for Erectile Dysfunction Drug STENDRA® (avanafil) – PRNewswire
NEW YORK, Dec. 8, 2021 /PRNewswire/ — Petros Pharmaceuticals, Inc. (“Petros” or “the Company”) (Nasdaq: PTPI), a leading provider of therapeutics for men’s health, today reports positive over-the-counter (OTC) draft label comprehension study results for its erectile dysfunction (ED) Drug STENDRA® (avanafil). This Pivotal Label Comprehension Study was designed to assess comprehension of a draft STENDRA® Drug Facts Label intended for OTC use. This study is a key component in the Compa…….
NEW YORK, Dec. 8, 2021 /PRNewswire/ — Petros Pharmaceuticals, Inc. (“Petros” or “the Company”) (Nasdaq: PTPI), a leading provider of therapeutics for men’s health, today reports positive over-the-counter (OTC) draft label comprehension study results for its erectile dysfunction (ED) Drug STENDRA® (avanafil). This Pivotal Label Comprehension Study was designed to assess comprehension of a draft STENDRA® Drug Facts Label intended for OTC use. This study is a key component in the Company’s plans to engage in discussions with the FDA to expand the product’s access through application for a possible OTC pathway. Early study indicators show positive label comprehension outcomes in the study, which has encouraged the Company to initiate the next step, a Self-Selection Study, as it continues to build the case for the FDA for OTC access to STENDRA.
“The label comprehension study is a key component of our plans to help expand access for STENDRA beyond the prescription model, and to make STENDRA potentially the first prescription-grade ED medication to become available over-the-counter in the United States. While the process of gathering data to be shared with the U.S. Food and Drug Administration (FDA) continues, we are enthusiastic about our progress toward providing new hope for the millions of men suffering from this condition,” commented Fady Boctor, Petros’s President and Chief Commercial Officer. “The switch to OTC is one of many approaches we are currently exploring to expand access to STENDRA. We remain steadfast in our dedication to men with ED by providing new and innovative options to help them safely, securely and discreetly obtain this medication.”
In the study, 453 subjects, including a significant number of low health literacy individuals, reviewed a draft OTC Drug Facts label, and were assessed to determine whether they could correctly understand nine key communication messages in the label. The comprehension of these nine primary points, combined with an additional 14 secondary messages, is intended to guide an individual’s appropriate selection and use of STENDRA in a potential OTC setting. The Company believes the topline results of this study demonstrate a strong assessment of comprehension of the draft OTC label communication messages, and that these label comprehension results will provide a strong framework for discussions with the FDA regarding the Company’s OTC development program. These label comprehension results also provided the foundation for initiating the necessary self-selection studies, and future actual use behavioral studies, for STENDRA as part of the OTC pathway.
It is estimated that only about 25% of the approximately 30 million men suffering from erectile dysfunction in the U.S. have received oral erectile dysfunction therapy.
About STENDRA® (avanafil)
STENDRA® (avanafil), originally launched by Auxilium Pharmaceuticals prior to that company’s sale to Endo Pharmaceuticals, is an oral phosphodiesterase 5 (PDE5) …….
