Lemonaid Health will offer customers more affordable access to branded ED medication STENDRA that may be taken as early as ~15 minutes prior to sexual activity (100mg and 200mg strengths only) [1]
Please see Important Safety Information and study design below
NEW YORK, NY / ACCESSWIRE / May 14, 2024/ Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces the availability of all strengths of the Company's prescription erectile dysfunction (ED) medication, STENDRA (avanafil) on the telehealth platform Lemonaid Health, Inc. Lemonaid Health is a subsidiary of 23andMe Holding Co. (Nasdaq: ME), and a leading telemedicine provider.
"With Lemonaid's nationwide distribution and industry leading track record of treating a significant number of ED patients across the country, we are excited to collaborate with Lemonaid Health in this expanded access initiative for STENDRA. This aligns with our core objectives to expand access to STENDRA for the appropriate patients, increase brand awareness across the prescription ED marketplace, and continue our pursuit of switching this critical therapy to over-the-counter (OTC) status for unprecedented expanded access. If eventually approved by the FDA for OTC, STENDRA would be the first ever prescription grade ED therapy available OTC," said Fady Boctor, Petros Pharmaceuticals' President and Chief Commercial Officer.
Lemonaid Health services patients across the United States and has treated a significant ED patient population to date. It provides access to medication delivery to eligible patients from a 50-state licensed pharmacy, which has the potential to help millions of men discreetly and legally obtain a treatment for a still significantly undertreated condition.
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, 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.
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 e?ects 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.
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 Lemonaid Health
Lemonaid Health, part of the 23andMe family, provides online telemedicine services in all 50 states and D.C. through its affiliated medical groups (subject to local laws). Prescriptions require completion of an independent medical consultation with a licensed healthcare provider through the Lemonaid online platform. Medications are only available if prescribed and in accordance with state laws and medical standards. Visit www.lemonaidhealth.com to learn more.
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
[1] Double-blind, placebo-controlled, 8-week trial of 440 men, 25.9% and 29.1% of patients, taking 100 mg and 200 mg respectively vs. 14.9% for placebo, achieved an erection sufficient for intercourse in as little as 15 minutes, Hellstrom, Wayne J.G.et al. "Efficacy of Avanafil 15 Minutes after Dosing in Men with Erectile Dysfunction: A Randomized, Double-Blind, Placebo Controlled Study," Journal of Urology, Vol. 194, p. 485-92 (August 2015). Across all clinical studies, adverse reactions occurring ≥2% with STENDRA 50 mg, 100 mg, and 200 mg vs placebo, respectively were headache (5.1%, 6.9%, 10.5% vs 1.7%), flushing (3.2%, 4.3%, 4.0% vs 0.0%), nasal congestion (1.8%, 2.9%, 2.0% vs 1.1%), nasopharyngitis (0.9%, 2.6%, 3.4% vs 2.9%), and back pain (3.2%, 2.0%, 1.1% vs 1.1%).
SOURCE: Petros Pharmaceuticals, Inc.
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