Petros Pharmaceuticals Extend Fall After Study News
By Chris Wack
Petros Pharmaceuticals Inc. shares were down 17% to $1.92
Wednesday, one day after the company said it has begun two
self-selection studies for its erectile dysfunction drug, Stendra
The stock closed Tuesday's session down 11%.
The company said the results of these studies will be part of a
more comprehensive data package it plans to submit to the U.S. Food
and Drug Administration to potentially achieve over-the-counter
status for Stendra.
Petros said a self-selection study ensures that consumers can
make appropriate decisions based on their own personal health
circumstances about whether to use a particular drug product. The
initiation of these self-selection studies follows encouraging
topline pivotal label comprehension results.
In the self-selection non-clinical studies, individuals who are
interested in utilizing an over-the-counter ED product are
recruited to review the draft over-the-counter labelling and to
determine whether the product is, or isn't, appropriate for them to
use without the intervention of a healthcare professional, the
Results from these two self-selection studies, one conducted in
the general population and the other specific to nitrate medicine
users, will be shared with the FDA for input and alignment for the
company's OTC development plan.
Petros said it expects to review the results with the FDA during
a pre-IND interaction it anticipates having during the first half
Write to Chris Wack at email@example.com
(END) Dow Jones Newswires
January 19, 2022 12:49 ET (17:49 GMT)
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