Petros Pharmaceuticals Announces Completion Of Human Factors Study, To Facilitate Patient's Access To Its Erectile Dysfunction Drug, Stendra Associated With The Company's Intended FDA Application For Prescription To OTC Switch
Portfolio Pulse from Benzinga Newsdesk
Petros Pharmaceuticals has completed a Human Factors Study, a key step in the FDA approval process for converting its prescription erectile dysfunction drug, Stendra, to over-the-counter (OTC) status. This study is intended to support the company's application for a prescription to OTC switch, potentially increasing patient access to Stendra.
December 12, 2023 | 3:04 pm
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Petros Pharmaceuticals' completion of the Human Factors Study is a significant milestone towards the potential OTC approval of Stendra by the FDA, which could lead to wider patient access and increased sales.
The completion of the Human Factors Study is a critical requirement by the FDA for the approval of prescription drugs for OTC use. Successfully completing this study suggests that Petros Pharmaceuticals is progressing on the regulatory path and may soon offer Stendra without a prescription. This could significantly increase the drug's market reach and sales, positively impacting PTPI's stock in the short term.
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