Study results provide support for OTC status of avanafil in erectile dysfunction

Final results from a phase 2 equivalent self-selection study for over-the-counter (OTC) use of the oral phosphodiesterase 5 inhibitor avanafil (Stendra) for erectile dysfunction show that use of a technology assistive application in combination with the drug facts label (DFL) enabled a statistically significant improvement in appropriate consumer self-selection vs the DFL alone.¹

If approved, avanafil may become the first erectile dysfunction medication in its class to successfully achieve OTC status

A self-selection study is conducted to support the approval of non-prescription drugs for OTC use. The study is designed to ensure that consumers can appropriately select to use a certain product based on information provided by the 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, such as a mobile application, 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. With an ACNU, the applicant must demonstrate and the FDA must determine that the DFL alone is insufficient for correct self-selection or appropriate actual use.

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 (Web App Technology), in line with the proposed ACNU rule, vs the DFL alone.

In total, the open-label, virtual, self-selection study included 509 participants who were randomly assigned to either use the DFL plus the Web App Technology or to use the DFL alone. Overall, data showed a 90.6% rate of correct consumer self-selection among those who used the Web App Technology vs 57.3% among those that used the DFL alone (P < .001).

“These are remarkable data points that we are looking forward to sharing with the FDA, as they clearly demonstrate the value of our proprietary Web App Technology having significant impact on guiding consumers to appropriate self-selection or deselection,” said Fady Boctor, president and chief commercial officer of Petros Pharmaceuticals, the developer of avanafil, in a news release on the findings.¹ “Further, we believe this strengthens our position as a candidate under the ACNU criteria, which enable expanded OTC access to medications that previously required a prescription. Clearly, the necessity of the technology was demonstrated by the results of the study, which the FDA requires as a necessary component for achieving ACNU status.”

Additional data from the study showed that among patients who identified as nitrate users (high-risk population), patients who used the Web App Technology (n = 56) demonstrated a point estimate of 98.21% for correct self-selection, vs 58.7% among those using the DFL alone (n = 46). This translated to a statistically significant difference of 67%.

"We are now focused on working closely with the FDA to share these and other data we have collected to continue the dialogue necessary to ultimately reach the stage where we will be able to conduct an ‘actual use' trial, which is the equivalent of a pivotal phase 3 clinical trial prior to filing a new drug application (NDA),” Boctor added in the news release.¹

Petros Pharmaceuticals also noted that if approved, avanafil may become the first erectile dysfunction medication in its class to successfully achieve OTC status.

Boctor concluded, “While there are additional pivotal trials to complete, we believe this trial represents significant progress. We look forward to providing additional updates on the development on an ongoing basis, including the ongoing integration and optimization of AI into the company's technology, which we also believe will continue to address vital FDA concerns.”¹

References

1. Petros Pharmaceuticals' STENDRA(R) (avanafil) pivotal consumer self-selection study for over-the-counter access demonstrates statistical significance. News release. Petros Pharmaceuticals. Published online and accessed July 16, 2024. https://feeds.issuerdirect.com/news-release.html?newsid=7909643705131048

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 July 16, 2024. https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/fda-announces-proposed-rule-nonprescription-drug-product-additional-condition-nonprescription-use