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     113  0 Kommentare Petros Pharmaceuticals Receives Positive Response from FDA Following Recent Demonstration of Technology Component in Pursuit of OTC Status for STENDRA(R) (avanafil) - Seite 3

    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.

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    Petros Pharmaceuticals Receives Positive Response from FDA Following Recent Demonstration of Technology Component in Pursuit of OTC Status for STENDRA(R) (avanafil) - Seite 3 (Please see important safety information below)NEW YORK, NY / ACCESSWIRE / April 16, 2024 / Petros Pharmaceuticals, Inc. ("Petros," or the "Company") (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the- …

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