Petros Pharmaceuticals soared nearly 50% in premarket trading as it reported positive label comprehension results for Stendra

Petros Pharmaceuticals soared nearly 50% in premarket trading as it reported positive label comprehension results for Stendra.The company reported positive over-the-counter (OTC) draft label comprehension study results for its erectile dysfunction (ED) Drug STENDRA®(avanafil). 

This Pivotal Label Comprehension Study was designed to assess comprehension of a draft STENDRA®Drug Facts Label intended for OTC use.  This study was a key component in the Company's plans to engage in discussions with the FDA to expand the product's access through application for a possible OTC pathway. 

Early study indicators showed positive label comprehension outcomes in the study, which had encouraged the Company to initiate the next step, a Self-Selection Study, as it continued to build the case for the FDA for OTC access to STENDRA.