Petros Pharmaceuticals Petros Pharmaceuticals Developing Artificial Intelligence Technology For Phase 2 Equivalent Study For STENDRA

Petros Pharmaceuticals Inc Ordinary Shares -0.73% Post

Petros Pharmaceuticals Inc Ordinary Shares

PTPI

0.42

0.41

-0.73%

-3.45% Post

New AI/machine learning tool designed to help potential users more effectively self-select in the effort to make STENDRA the first erectile dysfunction (ED) medication available OTC

Petros in discussions with third-party technology partners

NEW YORK, NY / ACCESSWIRE / October 30, 2023 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), ), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces the development of a technological component of its self-selection study utilizing machine learning/artificial intelligence (AI), which the Company plans to integrate into its self-selection studies for its erectile dysfunction drug STENDRAÒ (avanafil). The development of the technology and study design will continue to follow direct U.S. Food and Drug Administration (FDA) recommendations as well as published proposed guidelines currently being finalized by the Agency.

Fady Boctor, Petros' President and Chief Commercial Officer, commented, "We are developing this technology component using AI/machine learning in response to FDA feedback to provide an automated screening mechanism that should enhance the self-selection process and help mitigate that only men who are appropriate to use STENDRA should be able to gain access to the medication. We anticipate advancing the development of this technology tool leveraging the guidance we have already received from the FDA. In addition, we believe it will likely be refined and completed through third-party technology partnerships."

In addition to providing encouraging guidance about the STENDRA Drug Facts Label (DFL), paving the way for initiating Petros' Self-Selection Studies (SSS), the FDA provided specific guidance regarding what it would expect of the technology component. This feedback is in addition to general guidance from the FDA regarding Additional Conditions for Nonprescription Use (ACNU) criteria that enable correct self-selection by consumers. Furthermore, it may expand OTC access to medications that formerly could only be available by prescription. An ACNU may be an innovative computerized tool, or the additional conditions may use other approaches that support the switch process.

Mr. Boctor continued, "We continue to benefit from the FDA's guidance in our quest to make STENDRA the first erectile dysfunction drug to achieve OTC status in the United States. As previously disclosed, if we achieve positive self-selection data, including a proper testing of the technology component, and upon FDA clearance, we expect to move expeditiously into an actual use trial, akin to a Phase 3 registration trial in clinical development sequencing. We continue to believe our developmental methodology - which would include this AI-driven technology - may ultimately become a model for future programs seeking to switch prescription products to OTC marketing status," concluded Mr. Boctor.

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