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.
Rhea-AI Summary
Petros Pharmaceuticals, Inc. (PTPI) initiates an AI integrated Human Factors Study to enhance self-screening for STENDRA, aiming for OTC status. The collaboration with a software developer led to the successful launch of an AI tool integrated into the company's web app. The study, overseen by Fady Boctor, focuses on optimizing the safe administration of STENDRA and meeting FDA requirements. The Human Factors Study aims to evaluate the web tool's safety and effectiveness for users, potentially paving the way for STENDRA to become the first OTC erectile dysfunction medication.
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Petros Pharmaceuticals, Inc. partners with a leading AI software provider to integrate technology for self-screening to bring STENDRA over the counter, aiming to enhance consumer access to medication.
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Petros Pharmaceuticals, Inc. (NASDAQ:PTPI) has scheduled two meetings with the FDA to review the progress of developing STENDRA as the first PDE-5 inhibitor approved for over-the-counter use. The FDA has requested a listen-only meeting to review the app for improved productivity ahead of a Type C meeting on March 26, 2024, to discuss the development of the digital app and protocols for upcoming studies. Petros believes these meetings highlight the significant progress made in achieving OTC status for STENDRA and demonstrate the FDA's interest in the nonprescription development program.
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Petros Pharmaceuticals, Inc. announces successful completion of a Phase 2 equivalent Self-Selection Study (SSS) for STENDRA, with technology-enabled subjects correctly self-selecting to use the medication at a rate of over 78%, compared to 56% using the Drug Facts Label alone. The company plans to aggressively pursue a larger SSS cohort and continue discussions with the FDA for a viable pathway to over-the-counter (OTC) status. The study results have informed the development of the next phase of the study, and the company looks forward to providing updates on further development and collaboration with the FDA in 2024.
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Petros Pharmaceuticals, Inc. (Nasdaq:PTPI) completes Human Factors Study for STENDRA OTC approval
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Petros Pharmaceuticals, Inc. (NASDAQ:PTPI) partners with Idea Evolver to develop an application for Rx-to-OTC switch for STENDRA® (avanafil), an erectile dysfunction drug. This partnership aims to enhance the self-selection process for potential OTC approval, leveraging IE's experience in successful Actual Use Trials and technology-enabled prescription to OTC switch clinical studies. Petros looks forward to further collaboration with potential partners and the FDA to refine the process for STENDRA.
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Petros Pharmaceuticals, Inc. (NASDAQ:PTPI) partners with Idea Evolver (IE) to develop a technology platform for the Rx-to-OTC switch of its erectile dysfunction drug STENDRA® (avanafil). Idea Evolver is the only provider to successfully complete an Actual Use Trial for FDA review for Rx-to-OTC Switch Approval, and the partnership aims to enhance the self-selection process with potential AI/machine learning components.
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Petros Pharmaceuticals announces the development of a new AI/machine learning tool to enhance the self-selection process for its erectile dysfunction drug STENDRA. The technology will be integrated into self-selection studies and follow FDA recommendations. The company plans to collaborate with third-party technology partners for the completion of the tool.
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Petros Pharmaceuticals announces initiation of self-selection study for potential OTC version of STENDRA, an erectile dysfunction medication
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Petros Pharmaceuticals completes pivotal label comprehension study for potential non-prescription version of STENDRA, indicating positive results and paving the way for further development and collaboration with FDA.
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FAQ
What is the current stock price of Petros Pharmaceuticals (PTPI)?
The current stock price of Petros Pharmaceuticals (PTPI) is $0.2699 as of November 22, 2024.
What is the market cap of Petros Pharmaceuticals (PTPI)?
The market cap of Petros Pharmaceuticals (PTPI) is approximately 2.7M.
What is Petros Pharmaceuticals' main product?
Petros Pharmaceuticals' main product is STENDRA® (avanafil), an oral PDE5 inhibitor for the treatment of erectile dysfunction.
What are the primary segments of Petros Pharmaceuticals?
The primary segments are Prescription Medications and Medical Devices, with the latter being the main revenue generator.
What recent advancements has Petros Pharmaceuticals made?
Petros has integrated AI technologies for patient self-screening, received FDA feedback, and formed strategic partnerships to enhance access to STENDRA.
What is the significance of Petros Pharmaceuticals' AI integration?
The AI integration aims to optimize the self-screening and safe administration of STENDRA, facilitating its transition to over-the-counter availability.
How is Petros Pharmaceuticals expanding STENDRA's accessibility?
Through partnerships like the one with Lemonaid Health, Petros is expanding STENDRA's distribution via telehealth platforms.
What is the role of the Advisory Committee at Petros Pharmaceuticals?
The Advisory Committee, comprising former FDA officials and key opinion leaders, guides the Rx-to-OTC switch for STENDRA.
What are the key regulatory steps for STENDRA's OTC switch?
The key steps include designing a Drug Facts Label, conducting Label Comprehension Studies, Self-Selection Studies, and an Actual Use Trial to demonstrate safe and appropriate use.
What partnerships has Petros Pharmaceuticals recently formed?
Petros has formed partnerships with a leading AI software provider and Lemonaid Health to enhance STENDRA's accessibility and distribution.
What are the safety considerations for STENDRA?
STENDRA should not be used with organic nitrates or in patients with certain cardiovascular conditions. It should also be used cautiously with alpha-blockers, other antihypertensives, or substantial alcohol intake.
How is Petros Pharmaceuticals addressing unmet medical needs?
By driving innovations in the self-care market and expanding access to key prescription pharmaceuticals as OTC options, Petros aims to meet significant unmet medical needs.
Petros Pharmaceuticals, Inc.
Nasdaq:PTPI
PTPI Rankings
PTPI Stock Data
2.70M
9.20M
8.1%
2.29%
1.99%
Drug Manufacturers - Specialty & Generic
Pharmaceutical Preparations
United States of America
NEW YORK