Petros Pharmaceuticals Activates Advisory Committee to Help Guide Rx-to-OTC Switch for STENDRA
Petros Pharmaceuticals Activates Advisory Committee to Help Guide Rx-to-OTC Switch for STENDRA
Team composed of former FDA officials and key clinical and regulatory opinion leaders to help provide insight in preparation for collaboration with FDA
由前FDA官員以及主要臨床和監管意見領袖組成的團隊，爲與FDA的合作做準備提供見解
NEW YORK, NY / ACCESSWIRE / May 21, 2024 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces it has formed an Advisory Committee to provide guidance as the company prepares for the potential Rx-to-OTC switch for STENDRA for both development and communication with the U.S. Food and Drug Administration.
紐約州紐約/ACCESSWIRE/2024年5月21日/Petros Pharmicals, Inc.（納斯達克股票代碼：PTPI）是一家專注於通過非處方（OTC）藥物開發計劃擴大消費者獲得藥物渠道的公司，宣佈已成立一個諮詢委員會，爲該公司可能將STENDRA轉爲非處方藥以進行開發和與美國食品藥品監督管理局溝通提供指導。
"We believe this diverse team of subject matter experts, which include former FDA officials, will be instrumental in helping to ensure our development program is pursued with the same anticipated rigor we expect to experience when presenting the program to regulators," stated Fady Boctor, Petros's President and Chief Commercial Officer. "We believe thinking beyond our perspective as a manufacturer is critical to our ability to align with the FDA perspective, guidance, and concerns. Since piloting this Advisory Committee, we have experienced its value and synergy with FDA engagements."
Petros總裁兼首席商務官Fady Boctor表示：“我們相信，這支由包括前美國食品藥品管理局官員在內的多元化主題專家團隊將有助於確保我們的開發計劃以我們在向監管機構提交該計劃時所期望的同樣的嚴格程度進行開發。”“我們認爲，超越我們作爲製造商的視角思考對於我們與美國食品藥品管理局的觀點、指導方針和問題保持一致至關重要。自試行該諮詢委員會以來，我們已經體驗到了它的價值和與FDA合作的協同作用。”
The multi-disciplinary team is comprised of seven members, with industry-leading statisticians, clinical pharmacologists, as well as representatives in cardiology and urology. The team also hosts an impressive array of experience spanning industry, academia, and most importantly for the purposes of its formation, governmental agency. The committee will mimic the rigor and evidentiary standards exercised by the FDA on a regular basis as the company continues its development in pursuit of the Rx-to-OTC switch for STENDRA. These multi-disciplinary sector leaders will help the company craft a carefully calculated strategy that impacts study protocols, subject recruitment profiles, user-related risk analyses, and patient-centered considerations aimed at optimizing care in a potentially non-prescription setting.
該多學科團隊由七名成員組成，其中包括業界領先的統計學家、臨床藥理學家以及心臟病學和泌尿外科的代表。該團隊還擁有一系列令人印象深刻的經驗，涵蓋業界、學術界，最重要的是，就其組建而言，還包括政府機構。該委員會將定期模仿美國食品和藥物管理局實行的嚴格和證據標準，因爲該公司將繼續發展以尋求將STENDRA從非處方藥轉爲非處方藥。這些多學科領域的領導者將幫助公司制定精心設計的策略，該策略會影響研究方案、受試者招募概況、與用戶相關的風險分析以及以患者爲中心的考慮因素，旨在優化潛在非處方環境中的護理。
About Petros Pharmaceuticals
關於彼得羅斯製藥
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.
Petros Pharmicals致力於實現成爲新興自我保健市場的領先創新者的目標，推動擴大關鍵處方藥作爲非處方治療選擇的渠道。目前，Petros正在尋求通過潛在的非處方藥來增加其旗艦ED處方療法STENDRA的可及性。如果最終獲得美國食品藥品管理局的非處方藥准入，STENDRA可能是同類產品中第一個獲得這種上市地位的公司，也將公司的專業知識確立爲其他潛在處方療法的久經考驗的平台。
About the OTC Pathway
關於非處方藥途徑
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.
將處方藥改爲非處方藥（OTC）的過程首先涉及潛在消費者充分理解的藥物成分標籤（DFL）的設計。然後，數據必須表明，消費者只能根據有關DFL的信息及其個人病史做出使用或不使用該產品的適當決定。然後，消費者必須根據DFL上的信息證明他們可以正確使用產品。爲了完成這些任務，FDA通常要求使用經過消費者測試的非處方藥DFL。該測試包括在普通人群中進行迭代標籤理解研究（LCS），對有興趣使用該產品的人群和使用該產品可能受到傷害的特定人群進行自我選擇研究（SSS），通常還包括一項實際使用試驗（AUT），證明消費者在模擬非處方藥環境中安全合理地使用該產品。
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.
美國食品藥品管理局目前正在敲定的法規引入了非處方藥附加條件（ACNU）標準，該標準使消費者能夠進行正確的自我選擇，並可能擴大非處方藥獲得以前只能通過處方獲得的藥物的機會。ACNU 可能是一種創新的計算機化工具，或者附加條件可能使用支持切換過程的其他方法。
Important Safety Information about STENDRA (avanafil)
有關 STENDRA 的重要安全信息 （阿伐那非）
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.
斯滕德拉 （avanafil）最初由Auxilium Pharmicals在出售給遠藤製藥之前推出，是一種用於治療勃起功能障礙的口服磷酸二酯酶5（PDE5）抑制劑。STENDRA 不適用於女性或兒童。目前尚不清楚STENDRA對18歲以下的女性或兒童是否安全有效。（最早可以在性活動前大約 15 分鐘服用 100 毫克和 200 毫克的片劑。STENDRA 僅適用於性刺激，每天服用不應超過一次。STENDRA 可以與食物一起服用，也可以單獨服用；服用 STENDRA（例如，超過 3 杯葡萄酒或 3 杯威士忌）時不要喝太多酒精，因爲它會增加副作用的機會。在參加臨床試驗的人群中，分別有1.4％、2.0％和2.0％的人因副作用停止服用STENDRA（50 mg、100 mg或200 mg），而安慰劑的這一比例爲1.7％。斯滕德拉 專爲勃起功能障礙而設計和開發。
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.
STENDRA禁用任何形式的有機硝酸鹽，已知對片劑任何成分過敏的患者，以及使用鳥苷酸環化酶刺激劑的患者。
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.
如果由於心血管狀況或任何其他原因不建議進行性活動，則患者不應使用STENDRA。在服用 STENDRA 之前，請告訴醫生你是否有任何心臟問題，包括心臟病發作、心力衰竭、心絞痛和心跳不規則，或者血壓升高或過低。
Use of STENDRA with alpha-blockers, other antihypertensives, or substantial amounts of alcohol (greater than 3 units) may lead to hypotension.
將 STENDRA 與α-受體阻滯劑、其他降壓藥或大量酒精（大於 3 個單位）一起使用可能會導致低血壓。
Patients should seek emergency treatment if an erection lasts greater than 4 hours.
如果勃起持續時間超過 4 小時，患者應尋求緊急治療。
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.
如果一隻或兩隻眼睛突然出現視力喪失，患者應停止 STENDRA 並尋求醫療護理，這可能是非動脈缺血性視神經病變 (NAION) 的徵兆。與患者討論有NAION病史的患者中NAION的風險增加。
Patients should stop taking STENDRA and seek prompt medical attention in the event of sudden decrease or loss of hearing.
如果聽力突然下降或喪失，患者應停止服用 STENDRA 並立即就醫。
STENDRA can potentiate the hypotensive effect of nitrates, alpha blockers, antihypertensives, and alcohol.
STENDRA可以增強硝酸鹽、α受體阻滯劑、抗高血壓藥和酒精的降壓作用。
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.
CYP3A4 抑制劑（例如酮康唑、利托那韋、紅黴素）會增加 STENDRA 的暴露量。對於同時服用強效的 CYP3A4 抑制劑（包括酮康唑、利托那韋、阿扎那韋、克拉黴素、吲地那韋、伊曲康唑、奈法唑酮、奈非那韋、沙奎那韋和泰利黴素）的患者，請勿使用 STENDRA。
Combination with Other PDE5 Inhibitors or Erectile Dysfunction Therapies is not recommended.
不建議與其他PDE5抑制劑或勃起功能障礙療法聯合使用。
The safety of STENDRA is unknown in patients with bleeding disorders and patients with active peptic ulceration.
STENDRA在出血性疾病患者和活動性消化性潰瘍患者中的安全性尚不清楚。
The use of STENDRA offers no protection against sexually transmitted diseases including HIV. Consider counseling patients on protective measures for sexually transmitted diseases.
使用STENDRA無法預防包括HIV在內的性傳播疾病。考慮就性傳播疾病的保護措施向患者提供諮詢。
The most common adverse reactions reported with use of STENDRA include headache, flushing, nasal congestion, nasopharyngitis, and back pain.
使用STENDRA時報告的最常見不良反應包括頭痛、潮紅、鼻塞、鼻咽炎和背痛。
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.
有關 STENDRA 的更多信息，請致電 844-458-4887。如果您想舉報不良事件或產品投訴，請致電 844-458-4887 聯繫我們。
You are encouraged to report negative side effects of prescription drugs to the FDA by calling 1-800-FDA-1088, or at .
我們鼓勵您致電 1-800-FDA-1088 或致電 FDA 向 FDA 報告處方藥的負面副作用。
Please see the full Prescribing Information and Patient Information.
請查看完整的處方信息和患者信息。
Cautionary Note Regarding Forward-Looking Statements
關於前瞻性陳述的警示說明
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.
本新聞稿包括經修訂的1933年《證券法》第27A條和經修訂的1934年《證券交易法》第21E條所指的前瞻性陳述。這些前瞻性陳述以 Petros Pharmicals, Inc. 爲基礎。”s（“Petros”、“我們”、“我們的”、“我們” 或 “公司”）管理層對未來事件的假設、預期、預測、意圖和信念。在某些情況下，諸如 “打算”、“發展”、“目標”、“計劃”、“預測”、“可能”、“將”、“項目”、“估計”、“預測”、“預測”、“相信”、“期望”、“繼續”、“潛力”、“機會”、“預測”、“應該”、“目標”、“戰略” 等類似表達，無論是在反映我們當前對未來事件以及運營、經濟和財務業績的看法的否定或肯定旨在識別前瞻性陳述，但不是識別此類陳述的唯一手段。此類前瞻性陳述只是預測，實際結果和某些事件和情況發生的時間可能與前瞻性陳述中描述的存在重大差異，原因是風險和不確定性、Petros執行業務戰略的能力，包括開發和商業化候選產品的計劃；Petros履行公開報告公司義務的能力；Petros遵守納斯達克股票市場上市標準的能力；與Petros的能力相關的風險繼續作爲持續經營企業；與Petros遭受重大損失的歷史相關的風險；與Petros依賴單一產品STENDRA商業化相關的風險；以及與Petros的任何產品或候選產品獲得監管部門批准或市場接受的能力相關的風險。可能導致實際業績與這些前瞻性陳述中預期的業績存在重大差異的其他因素包含在公司的定期報告以及公司已經或可能向美國證券交易委員會（“SEC”）提交的 “風險因素” 和 “管理層對財務狀況和經營業績的討論和分析” 等標題下提交的其他文件中。公司提醒讀者，本新聞稿中包含的前瞻性陳述僅代表我們截至本新聞稿發佈之日的信念、預期、估計和假設，無意爲未來業績提供任何保證。新的因素不時出現，我們不可能預測所有這些因素。此外，公司無法評估每個因素對我們業務的影響，也無法評估任何因素或因素組合在多大程度上可能導致實際業績與任何前瞻性陳述中包含的業績存在重大差異。因此，您不應過度依賴任何前瞻性陳述。
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.
除非聯邦證券法要求，否則公司沒有義務更新或修改本新聞稿中包含的任何前瞻性陳述，無論是由於新信息、未來事件、我們的觀點或預期的變化還是其他原因。
Contacts
聯繫人
Investors:
CORE IR
ir@petrospharma.com
投資者：
CORE IR
ir@petrospharma.com
Media:
Jules Abraham
CORE IR
917-885-7378
pr@coreir.com
媒體：
朱爾斯·亞伯拉罕
CORE IR
917-885-7378
pr@coreir.com
SOURCE: Petros Pharmaceuticals, Inc.
來源：彼得羅斯製藥公司
譯文內容由第三人軟體翻譯。