Welcome to our dedicated page for Petros Pharmaceuticals news (Ticker: PTPI), a resource for investors and traders seeking the latest updates and insights on Petros Pharmaceuticals stock.
Petros Pharmaceuticals, Inc. (NASDAQ: PTPI) is a pioneering men's health pharmaceutical company dedicated to advancing therapeutics that enhance medication adherence, tolerability, and preservation of male organic function. The company operates through two main segments: Prescription Medications and Medical Devices. Its cornerstone product, STENDRA® (avanafil), is an oral phosphodiesterase 5 (PDE5) inhibitor designed specifically for the treatment of erectile dysfunction. Currently, Petros is actively pursuing increased access to STENDRA through potential over-the-counter (OTC) designation, making it the first prescription-grade ED therapy to achieve this status.
The Medical Devices segment is the primary revenue generator, focusing on vacuum erection devices marketed both domestically and internationally. The Prescription Medications segment involves operations related to these devices and ongoing efforts to transition STENDRA to OTC availability. Recently, Petros has integrated advanced artificial intelligence (AI) technologies to enhance patient self-screening and ensure safe administration of STENDRA without the need for a prescription.
Recent Achievements and Partnerships:
- Successful collaboration with a leading AI software provider to develop a self-screening tool for STENDRA, enhancing the self-selection process under FDA guidance.
- Launch of a Human Factors Study incorporating the AI tool, aimed at optimizing the safe administration of STENDRA for OTC use.
- Positive feedback from the FDA on the AI technology's efficacy in addressing key concerns for OTC availability, especially for nitrate-using patients.
- Partnership with Lemonaid Health to expand the distribution of prescription STENDRA through their telehealth platform, improving accessibility for ED patients nationwide.
- Formation of an Advisory Committee comprising former FDA officials and key clinical and regulatory opinion leaders to guide the Rx-to-OTC switch process.
Petros Pharmaceuticals is committed to innovation in the self-care market, driving expanded access to essential prescription pharmaceuticals as OTC treatment options. Through strategic partnerships and technological advancements, the company aims to meet significant unmet medical needs and enhance the quality of life for men worldwide.
Petros Pharmaceuticals (NASDAQ:PTPI) is positioning itself in the healthcare technology sector by developing a proprietary platform for Rx-to-OTC drug transitions. Company President Fady Boctor, featured in 'The Intelligent Leadership Podcast,' discussed their strategy to utilize AI and quantum computing to expand consumer access to medications.
The company is developing technology tools around Drug Facts Label self-selection and AI implementation to ensure safe drug access. Their platform, supported by multiple research studies, aims to assist pharmaceutical companies in pursuing Rx-to-OTC switches, potentially opening opportunities for future pharma partnerships.
Petros Pharmaceuticals (NASDAQ:PTPI) announces a strategic shift to focus on developing its proprietary technology platform for Rx-to-OTC switch solutions across multiple therapeutic areas. The company is targeting the self-care market, valued at over $38 billion with a projected 5.6% annual growth rate over the next decade.
The company's technology platform, combining SaaS and Software as a Medical Device (SaMD), aims to facilitate Rx-to-OTC switches for various drugs. Petros is exploring quantum computing partnerships to enhance its AI technology by incorporating health records. As part of this strategic pivot, the company has deprioritized its previous focus on STENDRA's Rx-to-OTC switch.
Petros Pharmaceuticals (NASDAQ:PTPI) has announced successful results from an initial study testing consumer comprehension of its App Technology messaging for STENDRA (avanafil). The study, part of the FDA pathway for over-the-counter (OTC) access, showed high comprehension rates:
- 29 out of 31 objectives scored >90% comprehension Point Estimate (PE)
- 30 scored >86.7% PE
- All scored >80% PE
- 21 scored 100% PE
The company is now conducting a larger scale study with about 400 patients, expected to conclude in Q4 2024. This progress marks a significant step towards expanding consumer access to STENDRA through OTC distribution.
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.
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