Petros Pharmaceuticals Reports Positive Results in an Initial Cohort Two-Arm Self-Selection (Phase 2-Equivalent) Study for STENDRA(R) (avanafil) as it Pursues OTC Status
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Insights
The recent findings from Petros Pharmaceuticals regarding their self-selection study present a noteworthy intersection of medical technology and consumer healthcare. The data indicating a substantial increase in correct self-selection of STENDRA® for erectile dysfunction (ED) when a web app is used in conjunction with a Drug Facts Label (DFL) could have significant implications for the OTC drug market. The subgroup of nitrate users achieving 100% correct self-selection is particularly compelling, given the potential risks associated with incorrect self-administration of ED medication in this population.
From a medical research perspective, the technology's ability to guide patients more accurately than DFL alone is a leap forward in patient education and safety. This could lead to a paradigm shift in how OTC medications are dispensed, especially for conditions that traditionally required close medical supervision. However, the robustness of these findings will need to be confirmed in larger studies, such as the ongoing pivotal Phase 2 trial. If the technology proves to be consistently effective, it may set a precedent for regulatory bodies like the FDA to consider similar technology-assisted OTC solutions for other medications.
From an economic standpoint, the integration of web app technology in OTC medication self-selection could disrupt the current healthcare delivery model. By potentially reducing the need for physician consultations for certain medications, there could be a decrease in healthcare spending associated with ED treatments. Moreover, the success of such a technology could encourage investment and innovation in self-care digital health tools, further expanding the OTC market.
However, the cost-effectiveness of implementing such technology on a large scale must be considered. While initial funding seems sufficient according to Petros Pharmaceuticals, the long-term financial sustainability and pricing strategy for the consumer will be critical factors in the widespread adoption of the web app. Additionally, the company's stock valuation may be influenced by the market's perception of the potential for this technology to drive future revenue growth and reduce costs associated with healthcare delivery.
The positive outcome of the initial cohort study has significant regulatory implications. Achieving FDA approval for the first OTC prescription-grade ED medication would be a landmark event. It is essential to note that the Additional Condition of Nonprescription Use (ACNU) is a critical regulatory hurdle. The data suggest that the web app could satisfy the ACNU by ensuring patient safety and proper medication use without physician oversight.
However, the FDA's decision will likely hinge on the results of the larger pivotal study. The regulatory pathway for OTC drugs is stringent, especially for a medication like STENDRA®, which could have serious implications if misused. The company's strategy to conduct an actual use trial akin to a Phase 3 trial demonstrates a thorough approach to meeting regulatory requirements, which may positively influence the FDA's assessment.
Nitrate patients subgroup demonstrated
(Please see important safety information below)
NEW YORK, NY / ACCESSWIRE / April 2, 2024 / Petros Pharmaceuticals, Inc. (Nasdaq:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces positive results of an initial cohort of its self-selection study comparing the use of a Drug Facts Label (DFL) alone to a DFL in combination with a web app (technology component).
Fady Boctor, Petros' President and Chief Commercial Officer, commented, "This two-arm study, intended to directionally demonstrate that use of a DFL-alone would be insufficient for self-selection, while the proposed technology provided significantly improved results. This trial serves as a preliminary version of our pivotal Phase 2 study that is currently in-field, initiated earlier this month. The pivotal study is designed to provide the FDA with compelling evidence showing that users are able to determine the appropriateness of STENDRA® (avanafil) without the need for a physician and prescription."
In the 30-person study, approximately
"The positive results in this study are another step forward in our efforts to expand access to STENDRA to potentially become the first OTC prescription-grade therapeutic option for erectile dysfunction (ED). It is of particular importance that the subgroup of nitrate users, a population of high concern for the FDA, showed
As previously disclosed, the Company anticipates that in the event positive self-selection data are achieved following this study and the ongoing pivotal self-selection studies, and upon FDA study clearance, it would expeditiously initiate an actual use trial, akin to a Phase 3 registration trial in clinical development sequencing.
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.
Important Safety Information 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,
STENDRA is contraindicated with 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 3 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). 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," "pursuit," "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, including, without limitation, Petros' ability to execute on its business strategy, including its plans to develop and commercialize its product candidates; Petros' ability to receive clearance from the FDA to sell STENDRA as an Over-the-Counter treatment; 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
ir@petrospharma.com
Media:
Jules Abraham
CORE IR
917-885-7378
pr@coreir.com
SOURCE: Petros Pharmaceuticals, Inc.
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FAQ
What did Petros Pharmaceuticals announce regarding a self-selection study?
What percentage of users correctly self-selected with the DFL and technology component?
What is the significance of the results for nitrate users in the study?
What is the company's goal regarding STENDRA® (avanafil) in relation to the study results?
What future trial does Petros Pharmaceuticals anticipate initiating?
