Petros Prescribed drugs, Inc. (NASDAQ: PTPI) is a pharma firm targeted on figuring out, growing, and commercializing therapeutics for males’s well being points. It operates primarily by way of the enterprise segments of Prescription Drugs and Medical Units. At present, the corporate is engaged within the commercialization and improvement of Stendra, an FDA-approved PDE-5 inhibitor prescription medicine for the therapy of ED.
In an electronic mail dialog with AlphaStreet, the corporate’s president and chief business officer Fady Boctor spoke concerning the challenges and alternatives for the enterprise.
Please give a quick overview of the corporate and its operations
Petros Prescribed drugs is dedicated to turning 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. At present, 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 firms?
Petros is a lean, environment friendly, and hyper-focused group with the one patent-protected prescription ED medicine accessible in the marketplace, STENDRA (in the identical class of medicine as Viagra and Cialis). This permits the corporate’s prospects to change into a possible first mover, as the primary firm to doubtlessly introduce the first-ever prescription-grade pharmaceutical as a non-prescription or OTC therapy choice. The know-how and related strategies, together with custom-made know-how options, could also be relevant to different Rx merchandise at present out there that stand to achieve extra affected person shoppers 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), primarily competitively collaborating within the rising self-care market, with STENDRA as a attainable preliminary debut. Due to this fact, challenges will predominantly focus on future examine outcomes and regulatory authority decision-making by the FDA. Alternatives are vital, 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 medicine to OTC includes the design of a clear-to-layman, shelf-friendly medicine label, demonstrated comprehension of key security parameters, and confirmed acceptable client self-selection. The FDA ordinarily requires a consumer-tested OTC Drug Details label (DFL), Label Comprehension Research (LCS), Self-Choice Research (SSS), and not less than one Precise Use Trial (AUT) demonstrating secure and acceptable non-practitioner-guided, but consumer-led use. Lately, a communication by the FDA launched Extra Situations for Non-prescription Use (ACNU) standards which will increase OTC entry to a number of prescription medicines and allow progressive instruments to assist assist 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 examine protocols usually embody a number of main endpoints designed to guage the buyer’s understanding of explicit use circumstances and/or self-determination of acceptable use with particular person merchandise goal thresholds typically better than 90% comprehension or acceptable self-selection respectively.
What’s your technique for increasing the portfolio and pipeline, towards the backdrop of giving non-prescription standing to STENDRA?
At present, the technique is targeted on growing options for the Rx-to-OTC or nonprescription change of STENDRA. Nonetheless, future goal circumstances to be used could conceivably embody different widespread Main Care circumstances or widespread causes for Main Care visits also referred to as widespread RFVs, probably together with mild-to-moderate circumstances of UTIs, hypertension, arthritis, diabetes, despair, anxiousness, 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 growing STENDRA as a nonprescription therapy choice, in collaboration and underneath the authority of the FDA. Nonetheless, at present’s developments could have vital implications for tomorrow’s therapeutic candidates.