On April 19, the men’s health company, Petros Pharmaceuticals Inc. (PTPI) announced positive results of the Stendra O-T-C Label study for ED. The news caused an uptick in the stock as it rallied by over 20% in regular trading. Thus, after surging up to $1.33 at the close of the session, the stock succumbed to corrections in the after hours. PTPI then subtracted a value of 5.26% under corrections in late trading. Hence, the stock declined to a price of $1.26 a share in the pre-market on Tuesday.
PTPI O-T-C Label Study
The company had been conducting a pivotal over-the-counter (OTC) Label Comprehension Study of its ED drug Stendra. Compiling over 453 label comprehension interviews, the study determined comprehension of draft drug facts labeling for Stendra by individuals including those with low health literacy.
On Tuesday, PTPI shared positive results from the study which showed an understanding of the messages of the draft label. Moreover, the results demonstrated that over 95% of participants gave correct or acceptable responses to the evaluating questions. Therefore, these results give way for submission to the Food and Drug Administration for OTC labeling of the drug.
Hence, if Stendra is approved by the FDA, it will become the first prescription-grade ED medicine to be available over-the-counter in the U.S.
How Does the Market Look?
According to estimates, only about 25% of roughly 30 million men suffering from ED in the U.S. have received oral therapy. Furthermore, in the huge untapped market, many feel discomfort in receiving prescription medication for the issue. People tend to look for safe and discreet options available over the counter.
On top of this, with the lifestyle changes in today’s world with growing stress and hectic routines, mental disorders like depression are increasing at a fast pace. Subsequently, this leads to an increase in the frequency of ED among men as lifestyle and mental health have a huge impact.
The company has been working on increasing its reach in the market for its ED drug Stendra. As part of the reach expansion, availability over-the-counter is one of its strategies to provide the drug in a discreet manner while also increasing awareness of its importance. Early in 2022, PTPI partnered with Dr. Drew Pinsky for helping increase awareness of ED and Stendra. Dr. Pinsky is known for proving advice to people through his thorough knowledge and experience on sensitive or taboo topics. OTC availability of the drug is expected to dramatically expand its access to the market and boost growth.