Petros Pharmaceuticals, Inc. - PTPI STOCK NEWS

Petros Pharmaceuticals (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the-counter (OTC) drug development programs, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024 at the Lotte New York Palace Hotel.

Fady Boctor, President and Chief Commercial Officer of Petros Pharmaceuticals, will present a corporate overview on September 9, 2024. The presentation will be available on-demand starting at 7:00 AM ET. Interested investors can register for the conference online to access the presentation. Additionally, Mr. Boctor will be available for one-on-one meetings with registered conference investors.

Petros Pharmaceuticals (NASDAQ:PTPI) announced improved results in its pivotal self-selection study for STENDRA® (avanafil), advancing efforts to create the first Rx-to-OTC switch in the ED category. The study, involving 509 subjects, showed a 90.6% correct consumer self-selection using the company's proprietary Web App Technology, compared to 57.3% using Drug Facts Label alone. A post hoc analysis demonstrated even stronger results, with a 94.9% point estimate and 91.51% lower bound for correct self-selection.

The Web App, featuring an embedded validated diagnostic questionnaire, outperformed live interviews, particularly for high-risk nitrate users. These statistically significant results (p<.001) support Petros' position as a candidate for the FDA's Additional Conditions for Nonprescription Use (ACNU) program, potentially expanding OTC access to STENDRA®.

Petros Pharmaceuticals (NASDAQ:PTPI) announced significant results from a pivotal self-selection study for STENDRA® (avanafil), aimed at facilitating FDA-approved over-the-counter (OTC) access. The study, involving 509 subjects, demonstrated that consumers using Petros' proprietary Web App Technology achieved a 90.6% correct self-selection rate, compared to 57.3% using a Drug Facts Label (DFL) alone (p<.001).

Notably, high-risk nitrate users showed a 98.21% correct self-selection rate with the Web App, versus 58.7% with DFL alone. These results strengthen Petros' position as a candidate under the Additional Conditions for Nonprescription Use (ACNU) criteria, potentially expanding OTC access to STENDRA®. The company is now focused on sharing this data with the FDA and progressing towards an 'actual use' trial, equivalent to a pivotal Phase 3 clinical trial.

Petros Pharmaceuticals has successfully completed a Formative Human Factors study for its AI-integrated Web App designed to facilitate the OTC access of STENDRA® (avanafil). The study, which follows an AI licensing agreement with a major software provider, achieved a 90% or better error-free rate for nearly all 5,820 tasks assessed. This paves the way for the next phase of their program aimed at switching STENDRA® from Rx to OTC under FDA guidance. The study included 30 consumers, involving scenarios with no prior training, and even incorporated an innovative AI interface for user identity confirmation.

Petros Pharmaceuticals (NASDAQ:PTPI) has established an Advisory Committee to guide the potential Rx-to-OTC switch for STENDRA, their medication aimed at expanding consumer access through over-the-counter drug development.

The committee consists of seven experts, including former FDA officials and leaders in clinical and regulatory fields, with experience in industry, academia, and government. This multi-disciplinary team will help Petros ensure alignment with FDA standards and rigor in their development program.

The team will assist in crafting strategies for study protocols, subject recruitment, risk analyses, and patient-centered considerations to optimize care in a non-prescription setting. Petros believes this collaboration will provide significant value in their engagements with the FDA.

Petros Pharmaceuticals has launched the U.S. distribution of its prescription ED medication, STENDRA, through a new collaboration with Lemonaid Health, a subsidiary of 23andMe. This partnership aims to provide more affordable access to STENDRA, which can be taken 15 minutes before sexual activity in 100mg and 200mg strengths. Lemonaid Health, which has treated a significant number of ED patients across the U.S., will offer telehealth services for STENDRA, potentially aiding millions of men. The initiative aligns with Petros' goal to increase STENDRA's market presence and eventually transition it to over-the-counter (OTC) status if FDA approved.

Petros Pharmaceuticals, Inc. (Nasdaq:PTPI) partners with Lemonaid Health, a leading telemedicine provider, to expand the online distribution of prescription STENDRA (avanafil) for ED patients. This collaboration aims to increase access to medication through Lemonaid Health's telehealth platform, benefiting patients across the United States. Petros Pharmaceuticals emphasizes the importance of this partnership in enhancing distribution and access to STENDRA, while also working towards achieving OTC status for the medication under FDA guidance.

Petros Pharmaceuticals, Inc. (PTPI) receives positive feedback from the FDA for its technology component in pursuit of OTC status for STENDRA (avanafil). The FDA acknowledged the technology's addressing of concerns related to the PDE5 inhibitor class, particularly for nitrate-using patients. The Company's President sees this as a significant step towards achieving OTC status, with ongoing studies and guidance from the FDA shaping future development.

Petros Pharmaceuticals, Inc. (PTPI) announces positive results of a self-selection study comparing the use of a Drug Facts Label alone to a DFL in combination with a web app. The study shows significant benefits of technology assistance in an OTC setting, particularly for nitrate users. The company aims to provide compelling evidence to the FDA for nonprescription use of STENDRA® (avanafil) as an OTC option for erectile dysfunction.