Petros Pharmaceuticals' STENDRA(R) (avanafil) Pivotal Consumer Self-Selection Study for Over-the-Counter Access Demonstrates Statistical Significance
Vital study aligned with FDA guidelines shows encouraging performance as Petros continues close FDA contact for a potential technology-centered Rx-to-OTC switch
NEW YORK, NY / ACCESSWIRE / July 16, 2024 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI) ("Petros" or the "Company"), a company focused on expanding consumer access to medication through over-the-counter ("OTC") drug development programs, announces results of the first of a series of pivotal studies aimed at facilitating FDA-approved OTC access of STENDRA® (avanafil) for consumers. The pivotal self-selection study showed that consumers who used the Company's proprietary Web App Technology, designed to assist in the appropriate consumer self-selection for receiving the drug, had a statistically significant (p<.001) higher instance of correct consumer self-selection, compared to those who used a Drug Facts Label ("DFL") alone.
The study, which evaluated 509 subjects, demonstrated a 90.6% correct consumer self-selection for those who used the Company's Web App Technology, compared to 57.3% using a DFL alone (p<.001). Notably, those participants who identified as nitrate users (high-risk use population) also performed better using the Web App Technology (98.21%-point estimate, n=56), compared to using DFL alone (58.7%-point estimate, n=46), a significant difference between the two arms of the study in the high-risk population where Arm B (Web App Technology arm) outperformed Arm A (DFL alone arm) by 67%.
Fady Boctor, Petros' President and Chief Commercial Officer, noted, "These are remarkable data points that we are looking forward to sharing with the FDA, as they clearly demonstrate the value of our proprietary Web App Technology having significant impact on guiding consumers to appropriate self-selection or deselection. Further, we believe this strengthens our position as a candidate under the Additional Conditions for Nonprescription Use ("ACNU") criteria, which enable expanded OTC access to medications that previously required a prescription. Clearly, the necessity of the technology was demonstrated by the results of the study, which the FDA requires as a necessary component for achieving ACNU status.
"We are now focused on working closely with the FDA to share these and other data we have collected to continue the dialogue necessary to ultimately reach the stage where we will be able to conduct an ‘actual use' trial, which is the equivalent of a pivotal Phase 3 clinical trial prior to filing a New Drug Application (NDA). While there are additional pivotal trials to complete, we believe this trial represents significant progress. We look forward to providing additional updates on the development on an ongoing basis, including the ongoing integration and optimization of AI into the Company's technology, which we also believe will continue to address vital FDA concerns," concluded Mr. Boctor.
The pivotal self-selection study was a randomized, 2-arm, open-label, virtual, self-selection study intended to evaluate participant's self-selection with the DFL alone (Arm A) compared to the participant's self-selection with the DFL and the Web App Technology (Arm B). Based on the FDA Proposed Rule for a Nonprescription Product with an Additional Condition of Nonprescription Use (ACNU)1 the sponsor must "demonstrate that the labeling alone… is insufficient to ensure appropriate self-selection or appropriate actual use, or both." Therefore, the results of this randomized, 2-arm pivotal all-comers self-selection study are intended to provide critical evidence required by the FDA.
About Petros Pharmaceuticals
Petros Pharmaceuticals, Inc. is committed to the goal of becoming a leading innovator in the emerging self-care market driving expanded access to key prescription pharmaceuticals as OTC treatment options. Currently, Petros is pursuing increased access for its flagship prescription ED therapy, STENDRA® (avanafil), via potential OTC designation. (See important safety information below.) If ultimately approved by the FDA for OTC access, STENDRA® (avanafil) may be the first in its class to achieve this marketing status, also establishing company know how as a potentially proven platform for other prospective prescription therapeutics.
About the OTC Pathway
The process of switching a prescription medication to 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 informed 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 this, the FDA ordinarily requires a consumer tested OTC DFL. Such 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.
1 https://www.regulations.gov/document/FDA-2021-N-0862-0001
Important Safety Information about STENDRA® (avanafil)
STENDRA® (avanafil), originally launched by Auxilium Pharmaceuticals prior to its sale to Endo Pharmaceuticals, is an oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of erectile dysfunction. STENDRA® (avanafil) is not for use in women or children. It is not known if STENDRA® (avanafil) 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® (avanafil) 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® (avanafil) (for example, more than three glasses of wine or three 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® (avanafil) (50 mg, 100 mg, or 200 mg) due to side effects compared to 1.7% taking a placebo. STENDRA® (avanafil) was designed and developed expressly for erectile dysfunction.
STENDRA is contraindicated for any form of organic nitrates, in patients with known hypersensitivity to any component of the tablet, and in patients who are using a guanylate cyclase stimulator.
Patients should not use STENDRA if sexual activity is inadvisable due to cardiovascular status or any other reason. Before taking STENDRA, tell your doctor if you have had any kind of heart issues including heart attack, heart failure, angina and irregular heartbeat or have elevated or low blood pressure.
Use of STENDRA with alpha-blockers, other antihypertensives, or substantial amounts of alcohol (greater than three units) may lead to hypotension.
Patients should seek emergency treatment if an erection lasts greater than 4 hours.
Patients should stop STENDRA and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of Non-Arteritic Ischemic Optic Neuropathy ("NAION"). Doctors should discuss with patients the increased risk of NAION in patients with a history of NAION.
Patients should stop taking STENDRA and seek prompt medical attention in the event of sudden decrease or loss of hearing.
STENDRA can potentiate the hypotensive effect of nitrates, alpha blockers, antihypertensives, and alcohol.
CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, erythromycin) increase STENDRA exposure. For patients taking concomitant strong CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin), do not use STENDRA.
Combination with Other PDE5 Inhibitors or Erectile Dysfunction Therapies is not recommended.
The safety of STENDRA is unknown in patients with bleeding disorders and patients with active peptic ulceration.
The use of STENDRA offers no protection against sexually transmitted diseases including HIV. Consider counseling patients on protective measures for sexually transmitted diseases.
The most common adverse reactions reported with use of STENDRA include headache, flushing, nasal congestion, nasopharyngitis, and back pain.
For more information about STENDRA, call 844-458-4887. If you would like to report an adverse event or product complaint, please contact us at 844-458-4887.
You are encouraged to report negative side effects of prescription drugs to the FDA by calling 1-800-FDA-1088, or at www.fda.gov/medwatch.
Please see the full Prescribing Information and Patient Information.
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 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.
The Company undertakes no obligation to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events, a change in our views or expectations or otherwise, except as required by federal securities laws.
Contacts
Investors:
CORE IR
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Media:
Jules Abraham
CORE IR
917-885-7378
[email protected]
SOURCE: Petros Pharmaceuticals, Inc.
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