Study of avanafil for OTC use in erectile dysfunction progresses

The initial cohort of the phase 2 equivalent self-selection study (SSS) for over-the-counter (OTC) use of the oral phosphodiesterase 5 inhibitor avanafil (Stendra) for erectile dysfunction has successfully completed, according to a news release from Petros Pharmaceuticals, the developer of the treatment.¹

The results from the current study will inform the development of the second cohort for the phase 2 equivalent SSS.

An SSS is conducted to support the approval of non-prescription drugs. The study is designed to ensure that consumers can appropriately select to use a certain product based on information provided by the drug facts label (DFL).

An additional regulation that is currently being finalized by the FDA is the Additional Conditions for Nonprescription Use (ACNU) criteria, which would allow applicants to introduce certain conditions to enable appropriate self-selection among consumers.² The purpose for the proposal is to expand access to non-prescription drug products that may only be currently available through a prescription.

The current open-label study of avanafil was designed to evaluate the ability of patients to appropriately self-select to use the drug using the DFL and a technology assistive application, in line with the proposed ACNU rule, vs the DFL alone. Overall, more than 78% of consumers were able to appropriately self-select to use avanafil using the DFL and the app, compared with 56% of consumers using the DFL alone.

According to Petros Pharmaceuticals, the results from the current study will inform the development of the second cohort for the phase 2 equivalent SSS, which is expected to launch soon. The second cohort will include a larger participant population who will utilize the DFL alone. Completion of that cohort will initiate a larger population SSS that will again include the assistive app.

"The success of this first part of our phase 2 equivalent self-selection study paves the way for us to aggressively pursue a larger SSS cohort, for which we expect to have results by the end of 2024. We believe our current cash runway will be more than sufficient to complete phase 2 equivalent which, if successful, we believe will be a significant factor in driving shareholder value. This initial cohort was a consumer-centered technology study resulting from our continued development and strengthening of our technology platform as we continue our efforts for an Rx-to-OTC switch for Stendra," said Fady Boctor, the president and chief commercial officer of Petros Pharmaceuticals, in the news release.¹

The company also noted that if approved, avanafil would become the first erectile dysfunction medication to successfully achieve OTC status.

Boctor concluded, "These results, along with all our work over the last year, have been submitted to the U.S. Food and Drug Administration (FDA) for review with the intention of continuing our discussions with the Agency on a viable pathway to OTC. We look forward to providing updates on further development, including the prospects of integrated AI tools, and additional opportunities to meet and share these outcomes with the FDA in the first half of 2024.”¹

Additional data on avanafil

In 2022, the FDA updated the label for avanafil to include positive clinical trial data for use of the drug in men with erectile dysfunction after receiving radical prostatectomy.³

The data were from a randomized, double-blind, parallel, placebo-controlled phase 3 trial (NCT00895011) that enrolled patients experiencing erectile dysfunction after receiving a bilateral, nerve-sparing radical prostatectomy. Data from the trial showed statistically significant improvements in all 3 efficacy variables, which included changes in the amount of sexual attempts patients were able to achieve an erection, a change in the amount of sexual attempts patients were able to achieve penetration, and changes in International Index of Erectile Function – Erectile Function Domain (IIEF-EF) scores.

The most common adverse events reported were headache, flushing, upper respiratory infection, nasal congestion, back pain, electrocardiogram abnormal, and dizziness.

References

1. Petros Pharmaceuticals demonstrates positive results following successful completion of initial cohort of phase 2 equivalent self-selection study for STENDRA (avanafil) Rx-to-OTC switch. News release. Petros Pharmaceuticals. January 17, 2024. Accessed January 19, 2024. https://finance.yahoo.com/news/petros-pharmaceuticals-demonstrates-positive-results-140000126.html

2. The FDA announces proposed rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use. News release. FDA. Last updated June 27, 2022. Accessed January 19, 2024. https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/fda-announces-proposed-rule-nonprescription-drug-product-additional-condition-nonprescription-use

3. New FDA-approved labeling for Petros Pharmaceuticals’ STENDRA (avanafil) now includes efficacy data regarding use in men who have undergone radical prostatectomy. News release. Petros Pharmaceuticals. October 25, 2022. Accessed January 19, 1024. https://www.biospace.com/article/releases/new-fda-approved-labeling-for-petros-pharmaceuticals-stendra-avanafil-now-includes-efficacy-data-regarding-use-in-men-who-have-undergone-radical-prostatectomy/