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 avanafil.

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 company said.

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 of 2022.

 

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

 

(END) Dow Jones Newswires

January 19, 2022 12:49 ET (17:49 GMT)

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