主要目的：本研究以昆明积大制药股份有限公司研制的阿伐那非片（100 mg）为受试制剂，按生物等效性研究的有关规定，以Menarini-Von Heyden GmbH生产的阿伐那非片（商品名：Spedra®，规格：100 mg）为参比制剂，评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。次要目的：观察受试制剂阿伐那非片和参比制剂阿伐那非片（商品名：Spedra®）在健康受试者中的安全性。

[Translation]

Main purpose: This study used avanafil tablets (100 mg) developed by Kunming Jida Pharmaceutical Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, avanafil tablets (trade name: Spedra®, specification: 100 mg) produced by Menarini-Von Heyden GmbH were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions. Secondary purpose: Observe the safety of the test preparation avanafil tablets and the reference preparation avanafil tablets (trade name: Spedra®) in healthy subjects.

Start Date14 Jun 2023

Sponsor / Collaborator

Kunming Jida Pharmaceutical Co. Ltd.

CTR20221316 / CompletedNot Applicable

阿伐那非片在空腹/餐后给药条件下随机、开放、单剂量、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of avanafil tablets under fasting/fed administration conditions

主要研究目的：本试验旨在在空腹和餐后单次口服给药条件下，以药动学参数为终点指标，考察扬州市三药制药有限公司生产的阿伐那非片（100mg）与Menarini-Von Heyden GmbH生产的阿伐那非片（Spedra，100mg）在健康男性受试者中的药代动力学特征，对两制剂的生物等效性进行评价。次要研究目的：评价在空腹和餐后单次口服给药条件下，扬州市三药制药有限公司生产的阿伐那非片（100mg）的安全性。

[Translation]

Main study purpose: This study aims to investigate the pharmacokinetic characteristics of avanafil tablets (100 mg) produced by Yangzhou Sanyao Pharmaceutical Co., Ltd. and avanafil tablets (Spedra, 100 mg) produced by Menarini-Von Heyden GmbH in healthy male subjects under the conditions of single oral administration on an empty stomach and after a meal, with pharmacokinetic parameters as the endpoint indicators, and to evaluate the bioequivalence of the two preparations. Secondary study purpose: Evaluate the safety of avanafil tablets (100 mg) produced by Yangzhou Sanyao Pharmaceutical Co., Ltd. under the conditions of single oral administration on an empty stomach and after a meal.

Start Date26 May 2022

Sponsor / Collaborator

Yangzhou Sanyao Pharmaceutical Co. Ltd.

CTRI/2020/01/022798 / RecruitingPhase 3

A prospective, randomized, double-blind, twoarm,active-controlled, parallel, multicentre,non-inferiority phase III clinical trial to assessthe efficacy and safety of Avanafil ascompared to Sildenafil in patients with ErectileDysfunction

Start Date03 Feb 2020

Sponsor / Collaborator

Zydus Healthcare Ltd.

100 Clinical Results associated with Avanafil

100 Translational Medicine associated with Avanafil

100 Patents (Medical) associated with Avanafil

230

Literatures (Medical) associated with Avanafil

01 Jan 2024·Pharmacoepidemiology and drug safety

Oral phosphodiesterase type 5 inhibitors and priapism: A VigiBase analysis

Article

Author: Lui, Jason L ; Breyer, Benjamin N ; Shaw, Nathan M ; Nabavizadeh, Behnam ; Hakam, Nizar ; Abbasi, Behzad

Abstract:

Purpose:

To explore the differences of priapism events among a diverse cohort taking erectogenic medicines (i.e., phosphodiesterase type 5 inhibitors [PDE5i] and intracavernousal drugs).

Methods:

We queried the World Health Organization global database of individual case safety reports (VigiBase) for records of the adverse drug reactions (ADR) with sildenafil, tadalafil, avanafil, vardenafil, papaverine, and alprostadil. Disproportionality analyses (case/non‐case approach) were performed to assess the reporting odds ratio (ROR) of priapism reporting in PDE5i consumers compared to intracavernousal drug recipients.

Results:

From a total of 133 819 ADR events for erectogenic medications, 632 were priapism (PDE5is: n = 550, 0.41%; intracavernousal drugs: n = 82, 9.92%). Priapism disproportionality signals from intracavernousal drugs were 25 times stronger than PDE5is (ROR = 34.7; confidence interval [CI] 95%: 27.12–43.94 vs. ROR = 1.38; 95% CI: 1.24–1.54). For all PDE5i agents, the 12–17 years age group had the highest ROR (9.49, 95% CI: 3.76–19.93) followed by 2–11 years (4.31, 95% CI: 1.57–9.4). Disproportionality signals for consumers under 18 for both all PDE5is as a whole (ROR = 4.57, 95% CI: 2.48–7.73) and sildenafil (ROR = 4.89, 95% CI: 2.51–8.62) were stronger than individuals 18 or older (ROR = 1.06, 95% CI: 0.93–1.21 and ROR = 1.08, 95% CI: 0.91–1.26, respectively).

Conclusions:

PDE5i use shows disproportionate priapism signals which are higher in young patients.

21 Dec 2023·Journal of biomolecular structure & dynamics

Avanafil mediated dual inhibition of IKKβ and TNFR1 in an experimental paradigm of Alzheimer’s disease: in silico and in vivo approach

Article

Author: Nayak, Usha ; Chowdari Gurram, Prasada ; Nampoothiri, Madhavan ; Mudgal, Jayesh ; Begum, Farmiza ; Satarker, Sairaj ; Arora, Devinder ; Kumar, Gautam ; Mehta, Chetan

In Alzheimer's disease pathology, inhibitors of nuclear factor kappa-β kinase subunit β (IKKB) and Tumor necrosis factor receptor 1 (TNFR1) signaling are linked to neuroinflammation-mediated cognitive decline. We explored the role of a phosphodiesterase 5 inhibitor (PDE5I) with dual antagonistic action on IKKB and TNFR1 to inhibit nuclear factor kappa B (NF-kB) and curb neuroinflammation. In the in silico approach, the FDA-approved Zinc 15 library was docked with IKKB and TNFR1. The top compound with dual antagonistic action on IKKB and TNFR1 was selected based on bonding and non-bonding interactions. Further, induced fit docking (IFD), molecular mechanics-generalized Born and surface area (MMGBSA), and molecular dynamic studies were carried out and evaluated. Lipopolysaccharide (LPS) administration caused a neuroinflammation-mediated cognitive decline in mice. Two doses of avanafil were administered for 28 days while LPS was administered for 10 days. Morris water maze (MWM) along with the passive avoidance test (PAT) were carried out. Concurrently brain levels of inflammatory markers, oxidative parameters, amyloid beta (Aβ), IKKB and NF-kB levels were estimated. Avanafil produced good IKKB and TNFR1 binding ability. It interacted with crucial inhibitory amino acids of IKKB and TNFR1. MD analysis predicted good stability of avanafil with TNFR1 and IKKB. Avanafil 6 mg/kg could significantly improve performance in MWM, PAT and oxidative parameters and reduce Aβ levels and inflammatory markers. As compared to avanafil 3 mg/kg, 6 mg/kg dose was found to exert better efficacy against elevated Aβ , neuroinflammatory cytokines and oxidative markers while improving behavioural parameters.Communicated by Ramaswamy H. Sarma.

03 Nov 2023·Canadian liver journal

Combination vardenifil and tadalifil drug induced liver injury; case report and review of the literature of liver injury associated with phosphodiesterase type 5 inhibitors

Article

Author: Braxton, David R ; Xu, Brian ; Fong, Tse-Ling

Background::

Phosphodiesterase type 5 inhibitors (PDE5I) are prescribed for erectile dysfunction and pulmonary hypertension. Despite its widespread use, there are only seven cases of drug-induced liver injury (DILI) associated with PDE5I, none associated with vardenafil or avanafil. We report a patient who had taken vardenafil and tadalafil individually for several years without developing symptoms of liver injury. However, after taking vardenafil and tadalafil together on 2 consecutive days, he developed severe cholestasis.

Methods::

Causality was determined using Roussel Uclaf causality assessment method (RUCAM).

Results::

The patient is a 72-year-old White man in excellent health who drank 2 units of alcohol, three times/week. Previously, he had used vardenafil for more than 2 years and tadalafil for 3 months as single agent for erectile dysfunction without any complications. He took vardenafil and tadalafil for 2 consecutive days and 5 days later, he developed dyspepsia, loss of appetite, jaundice, and intense itching. Liver tests showed mixed cholestatic/hepatocellular pattern of injury. Histology showed marked cholestasis with minimal inflammation. He remained cholestatic for 5 weeks before a full recovery 2 months later. The patient then resumed vardenafil monotherapy with no recurrent liver dysfunction. RUCAM causality score 7 indicates that the combination of PDE5I is probable cause of liver injury. The similarities among the eight cases of PDE5I DILI include a relatively short latency, cholestatic histological features, and complete recovery. Biochemical pattern of liver injury is variable.

Conclusions::

PDE5I DILI is a rare event that can result in severe acute liver injury.

News (Medical) associated with Avanafil

29 May 2024

·www.biospace.com

Petros Pharmaceuticals Successfully Completes AI-Integrated Formative Human Factors Study Demonstrating Positive Interaction with Web App Designed for STENDRA(R) (avanafil) OTC Switch

Study paves the way toward a first-ever innovation program to include AI-optimization for FDA-guided Rx-to-OTC switch NEW YORK, NY / ACCESSWIRE / May 29, 2024 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI) ("Petros" or the "Company"), a company focused on expanding consumer access to medication through over-the-counter ("OTC") drug development programs, announces the successful completion of a Formative Human Factors study of its AI-integrated Web App, designed to facilitate OTC access of STENDRA® (avanafil) for consumers. This important development follows the Company's recent execution of an AI licensing agreement with a leading multi-billion dollar software provider announced earlier this year. The Web App (previously referred to as the "technology component") is an integral part of the Company's efforts to complete an Rx-to-OTC switch for STENDRA® (avanafil) under the guidance of the U.S. Food and Drug Administration. The study demonstrated a 90% or better error-free completion rate for nearly all 5,820 tasks assessed. The successful completion of the study paves the way for the Company to initiate the next stage of the evolving program, while continuing to optimize the AI component of the Web App. "The successful completion of the Human Factors Study and the positive outcomes we've seen to date continue to be encouraging signs of our progress in navigating the Rx-to-OTC switch for STENDRA® (avanafil). As we've previously indicated, we believe we have the potential to be first-in-class for the category with regards to OTC access," stated Fady Boctor, Petros' President and Chief Commercial Officer. "We continue to refine our program based on our regular interactions with the FDA, and the learnings from this study will allow us to continue to optimize the AI component of the Web App. Combined, we strongly believe in our approach and look forward to continuing development into the next indicated step for STENDRA® (avanafil) in a non-prescription setting." The Formative Human Factors study was conducted in a population of 30 consumers, including a cohort with limited literacy. The consumers were provided with five different use scenarios requiring correct demonstration of 194 different tasks using the Web App with no training or guidance. The study also included a proprietary AI interface that confirmed the identity of the consumer, a first-ever innovation for an Rx-to-OTC switch program. About Petros Pharmaceuticals Petros Pharmaceuticals, Inc. is committed to the goal of becoming a leading innovator in the emerging self-care market driving expanded access to key prescription pharmaceuticals as OTC treatment options. Currently, Petros is pursuing increased access for its flagship prescription ED therapy, STENDRA® (avanafil), via potential OTC designation. If ultimately approved by the FDA for OTC access, STENDRA® (avanafil) 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 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 informed 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 this, the FDA ordinarily requires a consumer tested OTC DFL. Such 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 its sale to Endo Pharmaceuticals, is an oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of erectile dysfunction. STENDRA® (avanafil) is not for use in women or children. It is not known if STENDRA® (avanafil) 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® (avanafil) 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® (avanafil) (for example, more than three glasses of wine or three 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® (avanafil) (50 mg, 100 mg, or 200 mg) due to side effects compared to 1.7% taking a placebo. STENDRA® (avanafil) was designed and developed expressly for erectile dysfunction. STENDRA is contraindicated for 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 three 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"). Doctors should 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 . 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," "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 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. View the original press release on accesswire.com

Drug Approval

21 May 2024

·www.biospace.com

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 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. "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." 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 pro user-related risk analyses, and patient-centered considerations aimed at optimizing care in a potentially non-prescription setting. 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, 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 eﬀects of prescription drugs to the FDA by calling 1-800-FDA-1088, or at 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," "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 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. View the original press release on accesswire.com

14 May 2024

·www.globenewswire.com

Lemonaid Health Now Offers Prescription ED Medication STENDRAⓇ Through Collaboration with Petros Pharmaceuticals

Lemonaid Health will offer customers more affordable access to fast-acting branded ED medication that works as quickly as 15 minutes prior to sexual activitySUNNYVALE, Calif., May 14, 2024 (GLOBE NEWSWIRE) -- Lemonaid Health, Inc., a subsidiary of 23andMe Holding Co., (Nasdaq: ME), and a leading telemedicine provider, is now offering Petros Pharmaceuticals, Inc.’s (Nasdaq: PTPI), prescription erectile dysfunction (ED) medication STENDRAⓇ (avanafil) through its telehealth platform. Working directly with STENDRAⓇ manufacturer Petros Pharmaceuticals, Lemonaid Health is able to offer the fast-acting ED medication at improved pricing. With one in 10 men estimated to have ED at some point in their lifetime1, Lemonaid Health clinicians are able to evaluate and prescribe patients a variety of ED medications at various price points and doses. “We look forward to working directly with pharmaceutical manufacturers like Petros to offer our patients improved prices and better access to brand name medications across our telemedicine offerings,” said Eland Siddle, Head of Pharmacy, Lemonaid Health. “Adding STENDRAⓇ to our ED medication offerings, gives patients more options when it comes to finding the right medication for their needs.” Lemonaid Health services patients across the United States, and has treated over 200,000 ED patients to date. It provides access to medication delivery 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. 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. About Lemonaid HealthLemonaid 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. Visit www.lemonaidhealth.com to learn more. Forward-Looking StatementsThis press release contains 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. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding 23andMe’s strategy, are forward-looking statements. The words "believes," "anticipates," "estimates," "plans," "expects," "intends," "may," "could," "should," "potential," "likely," "projects," “predicts,” "continue," "will," “schedule,” and "would" or, in each case, their negative or other variations or comparable terminology, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are predictions based on 23andMe’s current expectations and projections about future events and various assumptions. 23andMe cannot guarantee that it will actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements and you should not place undue reliance on 23andMe’s forward-looking statements. These forward-looking statements involve a number of risks, uncertainties (many of which are beyond the control of 23andMe), or other assumptions that may cause actual results or performance to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K, as filed with the Securities and Exchange Commission, and as revised and updated by our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The statements made herein are made as of the date of this press release and, except as may be required by law, 23andMe undertakes no obligation to update them, whether as a result of new information, developments, or otherwise. ContactsInvestor Relations Contact: investors@23andMe.comMedia Contact: press@23andMe.com 1 Cleveland Clinic, 2019

Drug Approval

100 Deals associated with Avanafil

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KEGG	Wiki	ATC	Drug Bank
D03217	Avanafil	G04BE10	DB06237

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Erectile Dysfunction	KR	JW PHARMACEUTICAL Corp.	17 Aug 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Functional disorder	Phase 3	CN	-	26 Jul 2018
Sexual function and fertility disorders NEC	Phase 3	RU	Sanofi	01 Jul 2015
Diabetes Mellitus	Phase 3	US	VIVUS, Inc.	01 Dec 2008
Renal injury	Phase 1	-	VIVUS, Inc.	01 Jan 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03169582 (NEWS) Manual	Phase 3	Erectile Dysfunction	220	Avanafil	wbhthmetcg(rtnhiihdji) = xfjxyqpkrn wjogegbylu (stttqesekr ) View more	Non-inferior	08 Sep 2022
				Sildenaifl Citrate	wbhthmetcg(rtnhiihdji) = mjluocznnm wjogegbylu (stttqesekr ) View more
NCT01768676 (CTgov)	Phase 4	Erectile Dysfunction	181	avanafil (Avanafil)	rahanbhqsy(abriezednz) = zbewyifpef spstuefnue (iinbgzelbt, vvqoobvdma - vqalswsvsy) View more	-	14 Dec 2015
				Placebo (Placebo)	rahanbhqsy(abriezednz) = cxjtewqlhe spstuefnue (iinbgzelbt, keumfwkkel - mbitartytq) View more
NCT02033200 (CTgov)	Phase 4	-	80	Stendra 200 mg+placebo (Active)	cvizwalfma(gpnjpvxisw) = mvvksdgnjb qsjiquxfmq (rvwyyiwhup, ajsnqagefm - fwypsngzad) View more	-	13 Mar 2015
				Stendra 200 mg+placebo (Placebo)	cvizwalfma(gpnjpvxisw) = kabxjkrhkg qsjiquxfmq (rvwyyiwhup, sckbuthwbg - norrrbfwac) View more
NCT01698684 (CTgov)	Phase 4	Erectile Dysfunction	440	Placebo (Placebo)	bphrpxwslh(snlzvpsblq) = ejqldbwttt rvyzghdgiy (bdctoonqqr, atclvwrvjx - iycznzmgwy) View more	-	27 Oct 2014
				Avanafil 100 mg (Avanafil 100 mg)	bphrpxwslh(snlzvpsblq) = baaoojbklg rvyzghdgiy (bdctoonqqr, kkjcmqjcuk - iiriahaygc) View more
NCT00853606 (Pubmed \| Int J Clin Pract)	Phase 3	Erectile Dysfunction	712	Avanafil 100 mg	zmdnhcmbhm(upbzzhhqkq) = omhdwbdodq fcowaeekdo (xgdqcsfdgn ) View more	-	01 Apr 2013
				Avanafil 200 mg	zmdnhcmbhm(upbzzhhqkq) = cbgruripho fcowaeekdo (xgdqcsfdgn ) View more
NCT00895011 (CTgov)	Phase 3	Erectile Dysfunction	298	Placebo (Placebo)	rqubyjdeuq(qxsigifqnx) = gykjkabmll bgctobnhfv (ttneqbdocy, pctzdanziy - bfliilxbvu) View more	-	28 Jun 2012
				Avanafil (Avanafil 100 mg)	rqubyjdeuq(qxsigifqnx) = jwmnitlxjn bgctobnhfv (ttneqbdocy, nzvpozaoet - vbnsfwvbzq) View more
NCT00853606 (CTgov)	Phase 3	Erectile Dysfunction	712	avanafil	qkxgycqdnt(sdtobfxowj) = xsliebvawc csjnsbuvrw (wpydcstbpf, gifdfgyqhs - kxjructjri) View more	-	28 Jun 2012
NCT00790751 (CTgov)	Phase 3	Erectile Dysfunction	646	placebo (Placebo)	nromrlxore(deonbljono) = dvqsxvbpjx qihfoysovz (nwyyxvrnhq, bsxzplyezp - ztlpszexpi) View more	-	28 Jun 2012
				avanafil (Avanafil 50 mg)	nromrlxore(deonbljono) = hgtdjlmnge qihfoysovz (nwyyxvrnhq, dilyqamjfj - eotqhqrcxi) View more
NCT00809471 (REVIVE-D, CTgov)	Phase 3	Diabetes Mellitus \| Erectile Dysfunction	390	placebo (Placebo)	feijjsbcpu(bkpahbnoll) = zcflwxjtfi zmzjnxuhpa (ruueipevjq, fiwqmjsvtt - xbnxkqzigq) View more	-	28 Jun 2012
				avanafil (Avanafil 100 mg)	feijjsbcpu(bkpahbnoll) = rnczrclzat zmzjnxuhpa (ruueipevjq, exwsjbbztp - funvayejkg) View more

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