Petros Pharmaceuticals Shares Up After Being Granted Meeting With FDA
July 27 2021 - 10:15AM
Dow Jones News
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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