NEW YORK - Petros Pharmaceuticals, Inc. (NASDAQ: PTPI), a company focused on expanding consumer access to medication through over-the-counter (OTC) drug development programs, announces the development of a technological component of its self-selection study utilizing machine learning/ artificial intelligence (AI), which the Company plans to integrate into its self-selection studies for its erectile dysfunction drug STENDRAO.
The development of the technology and study design will continue to follow direct U.S. Food and Drug Administration (FDA) recommendations as well as published proposed guidelines currently being finalized by the Agency.
Fady Boctor, Petros President and Chief Commercial Officer, commented, 'We are developing this technology component using AI/machine learning in response to FDA feedback to provide an automated screening mechanism that should enhance the self-selection process and help mitigate that only men who are appropriate to use STENDRA should be able to gain access to the medication. We anticipate advancing the development of this technology tool leveraging the guidance we have already received from the FDA. In addition, we believe it will likely be refined and completed through third-party technology partnerships.'
In addition to providing encouraging guidance about the STENDRA Drug Facts Label (DFL), paving the way for initiating Petros' Self-Selection Studies (SSS), the FDA provided specific guidance regarding what it would expect of the technology component. This feedback is in addition to general guidance from the FDA regarding Additional Conditions for Nonprescription Use (ACNU) criteria that enable correct self-selection by consumers. Furthermore, it may expand OTC access to medications that formerly could only be available by prescription. An ACNU may be an innovative computerized tool, or the additional conditions may use other approaches that support the switch process.
Mr. Boctor continued, 'We continue to benefit from the FDA's guidance in our quest to make STENDRA the first erectile dysfunction drug to achieve OTC status in the United States. As previously disclosed, if we achieve positive self-selection data, including a proper testing of the technology component, and upon FDA clearance, we expect to move expeditiously into an actual use trial, akin to a Phase 3 registration trial in clinical development sequencing. We continue to believe our developmental methodology - which would include this AI-driven technology - may ultimately become a model for future programs seeking to switch prescription products to OTC marketing status,' concluded Mr. Boctor.
About Petros Pharmaceuticals
Petros Pharmaceuticals is committed to the goal of becoming a leading innovator in the emerging self-care market driving expanded access to key prescription pharmaceuticals as Over-the-Counter treatment options. Currently, Petros is pursuing increased access for its flagship prescription ED therapy, STENDRA, via potential OTC designation. If ultimately approved by the FDA for OTC access, STENDRA may be the first in its class to achieve this marketing status, also establishing company know how as a proven platform for other prospective prescription therapeutics.
About the OTC Pathway
The process of switching a prescription medication to over-the-counter (OTC) first involves the design of a Drug Facts Label (DFL) that is well understood by potential consumers. Then data must show that consumers can make an appropriate decision to use or not to use the product based only upon the information on the DFL and their personal medical history. Then consumers must demonstrate that they can properly use the product based upon the information on the DFL. To accomplish these things, the FDA ordinarily requires a consumer tested OTC DFL. This testing includes conduct of iterative Label Comprehension Studies (LCS) in the general population, Self-Selection Studies (SSS) in a population interested in using the product and in specific populations who may be harmed if they use the product, and usually one Actual Use Trial (AUT) demonstrating safe and appropriate use by consumers in a simulated OTC setting.
The regulations that FDA is currently finalizing introduced Additional Conditions for Nonprescription Use (ACNU) criteria that enable correct self-selection by consumers and may expand OTC access to medications that formerly could only be available by prescription. An ACNU may be an innovative computerized tool, or the additional conditions may use other approaches that support the switch process.
About STENDRA (avanafil)
Stendra (avanafil), originally launched by Auxilium Pharmaceuticals prior to that company's sale to Endo Pharmaceuticals, is an oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of erectile dysfunction. STENDRA is not for use in women or children. It is not known if STENDRA is safe and effective in women or children under 18 years of age. (A 100-mg and 200-mg tablet can be taken as early as 15 minutes before sexual activity. STENDRA only works with sexual stimulation and should not be taken more than once a day. STENDRA can be taken with or without food; do not drink too much alcohol when taking STENDRA (for example, more than 3 glasses of wine or 3 shots of whiskey) as it can increase chances of side effects. Of people enrolled in clinical trials, 1.4%, 2.0%, and 2.0%, respectively, stopped taking STENDRA (50 mg, 100 mg, or 200 mg) due to side effects compared to 1.7% on placebo. Stendra was designed and developed expressly for erectile dysfunction. The Company recently undertook a relaunch of Stendra, generating gross revenues of approximately $30 million in 2019. Petros intends to accelerate the relaunch of Stendra with a well-funded commercial organization and refocused strategy.
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are based upon Petros Pharmaceuticals, Inc.'s ('Petros,' 'we,' 'our,' 'us' or the 'Company') management's assumptions, expectations, projections, intentions, and beliefs about future events. In some cases, predictive, future-tense or forward-looking words such as 'intend,' 'develop,' 'goal,' 'plan,' 'predict', 'may,' 'will,' 'project,' 'estimate,' 'anticipate,' 'believe,' 'expect,' 'continue,' 'potential,' 'opportunity,' 'forecast,' 'should,' 'target,' 'strategy' and similar expressions, whether in the negative or affirmative, that reflect our current views with respect to future events and operational, economic and financial performance are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. Such forward-looking statements are only predictions, and actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of risks and uncertainties, Petros' ability to execute on its business strategy, including its plans to develop and commercialize its product candidates; Petros' ability to comply with obligations as a public reporting company; Petros' ability to maintain compliance with the Nasdaq Stock Market's listing standards; risks related to Petros' ability to continue as a going concern; risks related to Petros' history of incurring significant losses; risks related to Petros' dependence on the commercialization of a single product, STENDRA and risks related to Petros' ability to obtain regulatory approvals for, or market acceptance of, any of its products or product candidates. Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are contained in the Company's periodic reports and in other filings that the Company has filed, or may file, with the U.S. Securities and Exchange Commission (the 'SEC') under the headings 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' and elsewhere. The Company cautions readers that the forward-looking statements included in this press release represent our beliefs, expectations, estimates and assumptions only as of the date of hereof and are not intended to give any assurance as to future results. New factors emerge from time to time, and it is not possible for us to predict all of these factors. Further, the Company cannot assess the effect of each such factor on our business or the extent to which any factor, or combination of factors, may cause actual results to be materially different from those contained in any forward-looking statement. Accordingly, you should not unduly rely on any forward-looking statements.
Contact:
Email: ir@petrospharma.com
Jules Abraham
Tel: 917-885-7378
Email: pr@coreir.com
PETROS PHARMACEUTICALS 
