Petros Pharmaceuticals Receives Response From FDA Following Recent Demonstration Of Technology Component In Pursuit Of OTC Status For STENDRA
Portfolio Pulse from Benzinga Newsdesk
Petros Pharmaceuticals, Inc. (NASDAQ:PTPI) received positive feedback from the FDA on its technology component for STENDRA's self-selection, aiming for OTC status. This feedback is a crucial step towards making STENDRA the first erectile dysfunction drug available OTC. The FDA's informal review acknowledged the technology's potential to address concerns related to the PDE5 inhibitor class, especially for nitrate-using patients. Petros plans to submit its pivotal two-arm Self-Selection study in 2H 2024, with further guidance on an upcoming Application Comprehension Study.
April 16, 2024 | 1:18 pm
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Petros Pharmaceuticals received encouraging feedback from the FDA on its technology for STENDRA's OTC status, planning a pivotal study submission in 2H 2024.
The positive feedback from the FDA significantly boosts Petros Pharmaceuticals' prospects of making STENDRA the first OTC erectile dysfunction drug. This development is likely to positively impact investor sentiment and the company's stock price in the short term, as it represents a major milestone in the drug's regulatory pathway and opens up a larger market potential.
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IMPORTANCE 90
RELEVANCE 100