Petros Pharmaceuticals Enters into AI Licensing Agreement with Leading Multi-Billion-Dollar Software Provider

ACCESSWIRE02-14

AI software expected to further enable Petros's efforts to make STENDRA the first ED product to be offered over the counter NEW YORK, NY / ACCESSWIRE / February 14, 2024 / Petros Pharmaceuticals, Inc....

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NEW YORK, NY / ACCESSWIRE / February 14, 2024 / Petros Pharmaceuticals, Inc. , a company focused on expanding consumer access to medication through over-the- counter  drug development programs, announces a new partnership with a leading, multi-billion-dollar AI software provider to adapt its technology for self-screening and other benefits as part of the Company's ongoing efforts to bring STENDRA over the counter. The technology will be integrated into the core tool the Company has already developed as part of its Self-Selection Study, which is currently underway.","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"PTPI":"Petros Pharmaceuticals Inc","BK4007":"制药"},"translate_title":"Petros Pharmaceuticals与领先的数十亿美元软件提供商达成人工智能许可协议","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"PTPI":1},"content_text":"AI software expected to further enable Petros's efforts to make STENDRA the first ED product to be offered over the counter\nNEW YORK, NY / ACCESSWIRE / February 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 a new partnership with a leading, multi-billion-dollar AI software provider to adapt its technology for self-screening and other benefits as part of the Company's ongoing efforts to bring STENDRA over the counter. The technology will be integrated into the core tool the Company has already developed as part of its Self-Selection Study, which is currently underway.\n\"We recognize the importance of integrating AI into our efforts to safely bring STENDRA over the counter under the FDA's guidance and within ACNU guidance. We are utilizing proven existing technology from one of the world's most successful and acknowledged leaders in the industry,\" stated Fady Boctor, Petros's President and Chief Commercial Officer. \"As previously announced, this AI-driven technology is meant 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 believe that it will be a streamlined, turn-key application, and we look forward to providing additional details both about the utilization, and the partnership itself in the coming weeks and months.\"\nAbout Petros Pharmaceuticals\nPetros 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.\nAbout the OTC Pathway\nThe 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.\nThe 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.\nImportant Safety Information about STENDRA® (avanafil)\nSTENDRA® (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.\nSTENDRA 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.\nPatients 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.\nUse of STENDRA with alpha-blockers, other antihypertensives, or substantial amounts of alcohol (greater than 3 units) may lead to hypotension.\nPatients should seek emergency treatment if an erection lasts greater than 4 hours.\nPatients 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.\nPatients should stop taking STENDRA and seek prompt medical attention in the event of sudden decrease or loss of hearing.\nSTENDRA can potentiate the hypotensive effect of nitrates, alpha blockers, antihypertensives, and alcohol.\nCYP3A4 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.\nCombination with Other PDE5 Inhibitors or Erectile Dysfunction Therapies is not recommended.\nThe safety of STENDRA is unknown in patients with bleeding disorders and patients with active peptic ulceration.\nThe use of STENDRA offers no protection against sexually transmitted diseases including HIV. Consider counseling patients on protective measures for sexually transmitted diseases.\nThe most common adverse reactions reported with use of STENDRA include headache, flushing, nasal congestion, nasopharyngitis, and back pain.\nFor 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.\nYou 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.\nPlease see the full Prescribing Information and Patient Information.\nCautionary Note Regarding Forward-Looking Statements\nThis 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, 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.\nThe 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.\nContacts\nInvestors:CORE IRir@petrospharma.com\nMedia:Jules AbrahamCORE IR917-885-7378pr@coreir.com\nSOURCE: Petros Pharmaceuticals, Inc.\n\nView the original \npress release on accesswire.com","kind":null,"is_publish_news":null,"is_publish_highlight":null,"is_publish_live":null,"is_publish_wemedia":null,"editions":null,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.22.4","shortVersion":"4.22.4","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2411304039"}