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Petros Prescribed drugs, Inc. (NASDAQ: PTPI) is a pharma firm centered on figuring out, creating, and commercializing therapeutics for males’s well being points. It operates primarily via the enterprise segments of Prescription Medicines and Medical Units. Presently, the corporate is engaged within the commercialization and improvement of Stendra, an FDA-approved PDE-5 inhibitor prescription treatment for the therapy of ED.
In an e-mail dialog with AlphaStreet, the corporate’s president and chief business officer Fady Boctor spoke in regards to the challenges and alternatives for the enterprise.
Please give a quick overview of the corporate and its operations
Petros Prescribed drugs is dedicated to changing into a number one innovator within the rising self-care market by driving expanded entry to key prescription prescribed drugs reminiscent of over-the-counter (OTC) or nonprescription therapy choices. Presently, Petros is pursuing elevated entry for its flagship prescription erectile dysfunction (ED) remedy, STENDRA, for potential OTC or nonprescription designation.
What differentiates Petros Prescribed drugs from different pharma corporations?
Petros is a lean, environment friendly, and hyper-focused group with the one patent-protected prescription ED treatment out there available on the market, STENDRA (in the identical class of treatment as Viagra and Cialis). This allows the corporate’s prospects to change into a possible first mover, as the primary firm to probably introduce the first-ever prescription-grade pharmaceutical as a non-prescription or OTC therapy choice. The know-how and related strategies, together with personalized expertise options, could also be relevant to different Rx merchandise at the moment out there that stand to succeed in extra affected person customers and not using a prescription or as an OTC therapy choice.
What are the important thing challenges and alternatives for the corporate within the males’s well being market?
In a current announcement, we’ve got emphasised our concentrate on establishing progressive mechanisms for switching merchandise from Rx to non-Rx designation (OTC), basically competitively taking part within the rising self-care market, with STENDRA as a doable preliminary debut. Subsequently, challenges will predominantly focus on future research outcomes and regulatory authority decision-making by the FDA. Alternatives are important, because the rising self-care market continues to develop and the Rx-to-OTC change market inside it produces roughly $39 billion in 2023 and is estimated to develop to $67 billion by 2033, in accordance with Future Market Perception’s Rx-to-OTC Swap Outlook.
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Are you able to present insights into the present scientific trials, together with their anticipated outcomes and timeline?
The method of switching a prescription treatment to OTC includes the design of a clear-to-layman, shelf-friendly treatment label, demonstrated comprehension of key security parameters, and confirmed applicable shopper self-selection. The FDA ordinarily requires a consumer-tested OTC Drug Information label (DFL), Label Comprehension Research (LCS), Self-Choice Research (SSS), and no less than one Precise Use Trial (AUT) demonstrating secure and applicable non-practitioner-guided, but consumer-led use. Not too long ago, a communication by the FDA launched Further Circumstances for Non-prescription Use (ACNU) standards which will increase OTC entry to a number of prescription drugs and allow progressive instruments to assist help the switching course of.
Petros has produced a number of iterations of an OTC DFL, accomplished a number of research evaluating comprehension of the DFL (each pivotal LCS and pilot SSS), and is now working with the FDA to determine the following steps estimated to incorporate a pivotal SSS scheduled to launch by finish of 2023. Typically powered by a 95% Confidence Interval, the research protocols usually embrace a number of main endpoints designed to guage the patron’s understanding of specific use circumstances and/or self-determination of applicable use with particular person merchandise goal thresholds usually larger than 90% comprehension or applicable self-selection respectively.
What’s your technique for increasing the portfolio and pipeline, in opposition to the backdrop of giving non-prescription standing to STENDRA?
Presently, the technique is concentrated on creating options for the Rx-to-OTC or nonprescription change of STENDRA. Nonetheless, future goal circumstances to be used could conceivably embrace different widespread Major Care circumstances or widespread causes for Major Care visits also called widespread RFVs, presumably together with mild-to-moderate circumstances of UTIs, hypertension, arthritis, diabetes, melancholy, nervousness, pneumonia, otitis media, again ache, and dermatitis as early ideas of curiosity. There may be a lot to perform with the present activity at hand in creating STENDRA as a nonprescription therapy choice, in collaboration and below the authority of the FDA. Nonetheless, right this moment’s developments could have important implications for tomorrow’s therapeutic candidates.
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