San Francisco, CA (UroToday.com) -- Petros Pharmaceuticals, Inc., a leading provider of therapeutics for men's health, has initiated two self-selection studies for its erectile dysfunction (ED) drug STENDRA® (avanafil). The results of these studies will be part of a more comprehensive data package the Company plans to submit to the U.S. Food and Drug Administration (FDA) to potentially achieve over-the-counter (OTC) status for STENDRA® (avanafil).
A self-selection study ensures that consumers can make appropriate decisions based on their own personal health circumstances about whether to use a particular drug product. The initiation of these self-selection studies follows encouraging topline pivotal label comprehension results which the Company recently announced.
In these self-selection non-clinical studies, individuals who are interested in utilizing an OTC ED product are recruited to review the draft OTC labelling and to determine whether the product is, or is not, appropriate for them to use without the intervention of a healthcare professional. Results from these two self-selection studies, one conducted in the general population and the other specific to nitrate medicine users -- a patient type of particular interest to the FDA -- will be shared with the FDA for input and alignment for the Company's OTC development plan. This is an important next step in the development plan to seek non-prescription status for STENDRA® and will inform whether changes or additional labelling may be necessary to guide appropriate use and to help secure FDA support for future studies.
Historically, the FDA has required pivotal label comprehension studies, pivotal self-selection studies (sometimes with targeted patient populations) and actual use trials.
"These self-selections studies are a key component to the pathway for the FDA-guided OTC candidacy, review and approval process. While the process of gathering data to be shared with the 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 recently completed label comprehension studies and these self-selection studies continue to enable us to refine and test our draft OTC label in broad as well as in targeted patient populations. We are looking forward to reviewing these results with the FDA during a pre-IND interaction we anticipate having during the first half of 2022."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.
Source: Petros Pharmaceuticals, Inc. 2022. "Petros Pharmaceuticals Launches Two Self-Selection Studies For Erectile Dysfunction Drug STENDRA® (Avanafil)". Prnewswire.Com.