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Agreement reached to expand distribution of avanafil for ED

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Petros also announced that it has received positive feedback from the FDA after the agency’s informal review of Petros’ technology component for self-selection.

Man talking with a doctor | Image Credit: © DragonImages - stock.adobe.com

"This is a significant development in the marketing and distribution of prescription STENDRA," said Fady Boctor, Petros’s president and chief commercial officer, in a news release.

Petros Pharmaceuticals, Inc recently announced a new collaboration with telemedicine provider and 23andMe subsidiary Lemonaid Health, in which prescription avanafil (Stendra) for the treatment of erectile dysfunction will be available through Lemonaid Health’s telemedicine platform.1

"This is a significant development in the marketing and distribution of prescription STENDRA, which remains a priority for Petros while we continue our efforts toward achieving OTC status for STENDRA under FDA guidance. Lemonaid Health is known for its ability to reach and serve patients across the United States, having treated over 200,000 ED patients to date. Lemonaid Health patients will also have access to medication delivery from a 50-state licensed pharmacy, and this collaboration would significantly improve our ability to help the millions of men discretely and legally obtain a treatment of a still significantly undertreated condition. We look forward to our collaboration with Lemonaid Health and to providing updates to our shareholders,” said Fady Boctor, Petros’s president and chief commercial officer, in a news release.1

Separately, Petros also announced that it has received positive feedback from the FDA after the agency’s informal review of Petros’ technology component for self-selection as Petros works to attain over-the-counter (OTC) status for avanafil.2

In a news release, Petros reported that the FDA acknowledged that the technology addressed some of its concerns regarding the phosphodiesterase 5 inhibitor class in that context, particularly regarding nitrate-using patients.

"We view this meeting with the FDA as a significant step in our efforts to move STENDRA to OTC status, a move that would be the first among erectile dysfunction drug manufacturers,” said Boctor in a news release.2 “We found the FDA's feedback following our recent meeting to be encouraging, and we will incorporate it as we continue to move forward. We are grateful for the input from our internal advisory committee and subject matter experts and are confident that the incorporation of assistive technology has the potential to improve our process, resulting in better outcomes in our studies. We continue to believe OTC STENDRA presents a unique opportunity to treat a significant unmet medical need and look forward to further guidance from the Agency as we continue our development efforts."

In addition, during a recent Type C meeting between Petros and the FDA, the company and agency also aligned regarding its 2H 2024 submission as well as review of the currently-underway pivotal 2-arm Self-Selection Study. The FDA also provided guidance on Petros’ next technology-centered study, the Application Comprehension Study, which Petros said will be announced after additional steps are completed.

REFERENCES

1. Petros Pharmaceuticals expands online distribution for prescription STENDRA(R) (avanafil) through new agreement with Lemonaid Health. News release. Petros Pharmaceuticals. April 23, 2024. Accessed April 26, 2024. https://feeds.issuerdirect.com/news-release.html?newsid=5891392028203040

2. Petros Pharmaceuticals receives positive response from FDA following recent demonstration of technology component in pursuit of OTC status for STENDRA(R) (avanafil). News release. Petros Pharmaceuticals. April 16, 2024. Accessed April 26, 2024. https://www.biospace.com/article/releases/petros-pharmaceuticals-receives-positive-response-from-fda-following-recent-demonstration-of-technology-component-in-pursuit-of-otc-status-for-stendra-r-avanafil-/

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