Petros Pharmaceuticals, Inc. announced initiation of a self- selection study using the Drug Facts Label (DFL) tested during its previously announced label comprehension study (LCS). Petros now launches this self- selection study in a simulated OTC setting that allows potential users to determine if they are appropriate candidates to use STENDRA based on their understanding of the label and personal medical history. This study is akin to a Phase 2 study in clinical development sequencing and is the next step in the Company's FDA-guided pathway towards a possible OTC version of STENDRA, the Company's prescription erectile dysfunction drug.

At a recent meeting with the Company, the FDA provided encouraging guidance about the STENDRA DFL, paving the way for Petros to enter the next phase of research in the OTC development program, a Self-Selection Study (SSS). The FDA was forthcoming about its appreciation of the potential public health benefit of addressing men's sexual health with nonprescription medication to treat ED. If ultimately approved by the FDA for OTC access, STENDRA may be the first in its class to achieve this marketing status, also establishing company know-how as a proven platform for other prospective prescription therapeutics.

To accomplish these things, the FDA ordinarily requires a consumer-tested OTCDFL. The regulations that FDA is currently finalizing introduced Additional Conditions for Nonprescription Use (ACNU) criteria that enable correct self- selection by consumers and may expand OTC access to medications that formerly could only be available by prescription. Of people enrolled in clinical trials, 1.4%, 2.0%, and 2.0%, respectively, stopped taking STENDRA (50 mg, 100 mg, or 200 mg) due to side effects compared to 1.7% on placebo.

If they would like to report an adverse event or product compliant, that reflect current views with respect to future events.