Petros Pharmaceuticals Launches Two Self-Selection Studies for ED Drug 

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 US have received oral erectile dysfunction therapy.

STENDRA (avanafil), originally launched by Auxilium Pharmaceuticals prior to that company’s sale to Endo Pharmaceuticals, is an oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of erectile dysfunction. STENDRA is not for use in women or children. It is not known if STENDRA® is safe and effective in women or children under 18 years of age. 100-mg and 200-mg tablets can be taken as early as ~15 minutes before sexual activity. STENDRA works only with sexual stimulation and should not be taken more than once a day. STENDRA can be taken with or without food; do not drink too much alcohol when taking STENDRA (for example, more than 3 glasses of wine or 3 shots of whiskey) as it can increase chances of side effects. Of people enrolled in clinical trials, 1.4%, 2.0%, and 2.0%, stopped taking STENDRA (50 mg, 100 mg, or 200 mg, respectively) due to side effects compared to 1.7% on placebo. STENDRA was designed and developed expressly for erectile dysfunction. Currently, STENDRA is covered for ~75% of commercially insured lives, with a co-pay as low as $0. For more information, visit https://STENDRA.com/.

Petros Pharmaceuticals is committed to the goal of becoming a world-leading specialized men’s health company by identifying, developing, acquiring, and commercializing innovative therapeutics for men’s health issues, including, but not limited to, erectile dysfunction, endothelial dysfunction, psychosexual and psychosocial ailments, Peyronie’s disease, hormone health, and substance use disorders.