By Chris Wack

 

Petros Pharmaceuticals Inc. shares rose 6% to $3.27 after the company said it has been granted a meeting with the U.S. Food and Drug Administration to discuss expansions and modifications to the labeling of its erectile dysfunction medication Stendra avanafil.

The company said the meeting is scheduled for September 2021.

Stendra is an FDA-approved, prescription oral phosphodiesterase 5 inhibitor for the treatment of ED. The company said it will discuss several potential areas of Stendra's prescribing information during the meeting with the FDA, as well as potential next steps.

Petros is proposing to modify the dosage so that Stendra can be taken twice within 24 hours, provided that the maximum dose in a day is less than 200 mg. The company is also requesting that the FDA allow the inclusion of results from a Phase III clinical study among ED sufferers following radical prostatectomy into Stendra's label.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

July 27, 2021 10:08 ET (14:08 GMT)

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