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Idea Evolver is the only provider to successfully complete Actual Use Trial for FDA review for Rx-to-OTC Switch Approval
NEW YORK, NY / ACCESSWIRE / December 12, 2023 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces its partnership with Idea Evolver (IE), a Technology platform for Rx-to-OTC switches and digital pharmaceutical launch solutions. The partnership will focus on developing an application to help facilitate the technology element for the Company's prescription to OTC switch for its erectile dysfunction drug STENDRA® (avanafil). The application will be developed using IE's proprietary Rx-to-OTC platform, CodeScripts.
Fady Boctor, Petros' President and Chief Commercial Officer, commented, "This first partnership around the technology aspects that will help to facilitate the Rx-to-OTC switch for STENDRA is an important development as it is a crucial aspect of ensuring that the appropriate patients safely have access to the OTC product, should it achieve FDA approval. The added benefit of a potential AI/machine learning component, which is being developed in response to FDA feedback to provide an automated screening mechanism, should enhance the self-selection process. Idea Evolver has the distinction of currently being the only technology provider in the space that has documented experience in advancing a currently available drug through an Actual Use Trial
successfully in its path to a potential OTC approval. We look forward to continued development of this tool and to further collaboration with other potential partners and the FDA as we continue to refine the process for STENDRA."
Idea Evolver has worked with multiple large healthcare organizations to provide various technology solutions. The company also took part in the only technology-enabled prescription to OTC switch clinical study published (Nissen et.al., JACC Vol. 78, No. 11, 2021, September 14, 2021:114-1123), which is also known as an Actual Use Trial for rosuvastatin (Crestor), which was included in an application to the FDA for OTC approval. The development of the technology, which Petros intends to use for future studies as well as in practice, will be based on provided branding, consumer research, and behavior analysis. The collaboration between Petros and Idea Evolver will focus on incorporating Idea Evolver's experience with human factors and usability engineering into the application's design, as well as developing artificial intelligence components.
Posted In: PTPI