Background:
Obesity and related illnesses cause at least 2.8 million deaths each year worldwide. Few treatments exist for obesity that are safe and widely available. A study drug (mirabegron [MG]) combined with a supplement (alpha-lipoic acid [ALA]) may help.
Objective:
To learn how MG and ALA can help the body process food.
Eligibility:
People aged 18 to 65 years with a body mass index between 30 and 40 kg/m2.
Design:
Participants will be screened. They will have a physical exam. They will have blood and urine tests and a test of their heart function. They will speak with a dietician.
The study has two phases. Each phase begins with a 2-day stay in the clinic; then the participant will take the study drugs at home for about 4 weeks, followed by another 2-day stay in the clinic. They will also have outpatient visits about 2 weeks after each clinic stay.
During the clinic stays, participants will undergo many tests:
They will have a plastic tube (catheter) inserted into a vein in each arm. These will be used to draw blood and to infuse glucose (sugar) and insulin.
They will have imaging scans.
They will have a clear hard plastic shield placed over their head to measure oxygen and carbon dioxide as they breathe.
Participants will take the study drugs at home. Both MG and ALA are taken by mouth with water. During one phase, participants will take MG plus a placebo. A placebo looks like the study drug but doesn t contain medicine.
They will log their diet, exercise, and sleep....

Start Date26 Jun 2024

Sponsor / Collaborator

National Institute of Diabetes & Digestive & Kidney Diseases

NCT06465576 / RecruitingPhase 4IIT

Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry)

The primary objective is to investigate if abrupt withdrawal versus gradual withdrawal of pharmacotherapy (solifenacin and/or mirabegron) influences the risk of recurrence of incontinence.
Children aged 5-14 years diagnosed with urinary incontinence, treated with pharmacotherapy of solifenacin and/or mirabegron and ready for withdrawal will be randomized 1:1 to either abrupt or gradual withdrawal, according to the medical treatment that the child is receiving.

Start Date27 May 2024

Sponsor / Collaborator

University of Aarhus

CTR20240863 / Active, not recruitingNot Applicable

米拉贝隆缓释片在中国健康志愿者中空腹状态下生物等效性试验

[Translation] Bioequivalence study of mirabegron sustained-release tablets in Chinese healthy volunteers under fasting condition

主要目的：在中国健康受试者中评价空腹状态单次给药浙江普利药业有限公司生产的米拉贝隆缓释片（受试制剂，50mg）与美国上市米拉贝隆缓释片（参比制剂，Myrbetriq®，50mg）的人体生物等效性次要目的：在中国健康受试者中观察空腹状态单次给药米拉贝隆缓释片受试制剂和参比制剂的安全性

[Translation]

Primary objective: To evaluate the bioequivalence of single-dose mirabegron sustained-release tablets (test preparation, 50 mg) produced by Zhejiang Puli Pharmaceutical Co., Ltd. and mirabegron sustained-release tablets (reference preparation, Myrbetriq®, 50 mg) marketed in the United States in healthy Chinese subjects under fasting conditions Secondary objective: To observe the safety of single-dose mirabegron sustained-release tablets test preparation and reference preparation in healthy Chinese subjects under fasting conditions

Start Date09 Apr 2024

Sponsor / Collaborator

Zhejiang Puli Pharmaceutical Co., Ltd.

100 Clinical Results associated with Mirabegron

100 Translational Medicine associated with Mirabegron

100 Patents (Medical) associated with Mirabegron

820

Literatures (Medical) associated with Mirabegron

01 Mar 2024·Journal of pharmaceutical and biomedical analysis

Simultaneous quantification of mirabegron and vibegron in human plasma by HPLC-MS/MS and its application in the clinical determination in patients with tumors associated with overactive bladder

Article

Author: Cheng, Mengting ; Lou, Yutao ; Zhang, Yuan ; Lin, Sisi ; Bao, Meihua ; Qin, Hui ; Li, Kening ; Zhang, Yiwen ; Cao, Qin

Mirabegron and vibegron, both newly identified beta-3 adrenergic agonists, have significantly improved the quality of life for patients suffering from overactive bladder. In order to comprehensively assess the plasma exposure levels of these agents, the development of a rapid and highly sensitive bioanalytical method becomes imperative. The primary objective of this study was to establish a robust high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method for the concurrent quantification of mirabegron and vibegron in human plasma. The analytes were extracted from a 100 μL plasma sample through protein precipitation, employing 300 μL of methanol. Subsequently, samples underwent separation and quantification using a Waters XBridge C₁₈ column (2.1 × 100 mm, 3.5 µm), with a mobile phase consisting of 0.1% formic acid in water and 0.1% formic acid in acetonitrile. The mass analysis was conducted using positive electrospray ionization (ESI+) operated in a multiple reaction monitoring (MRM) mode. The proposed method was meticulously validated in accordance with the guidelines set forth by the U.S. Food and Drug Administration (FDA) for bioanalytical method validation. The regression equations demonstrated exceptional linearity for both mirabegron (r² ≥ 0.994) and vibegron (r² ≥ 0.996) across the concentration range of 0.5 - 200 ng/mL. Furthermore, the assay exhibited accuracy (inter-day relative error ≤ 6.90%) and precision (inter-day coefficient of variation ≤ 8.88%). The average recoveries of the analytes were found to range from 81.94% to 102.02%, with mean matrix effects falling within the range of 89.77% to 110.58%. As a result, this method was deemed highly suitable for the precise determination of the concentrations of both mirabegron and vibegron in the context of therapeutic drug monitoring and bioequivalence studies.

01 Jan 2024·BJU international

Detrusor relaxing agents for neurogenic detrusor overactivity: a systematic review, meta‐analysis and network meta‐analysis

Review

Author: Wang, Xuesheng ; Zhou, Zhonghan ; Li, Xunhua ; Liao, Limin

Objective:

To evaluate the evidence regarding the therapeutic benefits and safety of oral detrusor relaxing agents (DRAs) in treating neurogenic detrusor overactivity (NDO).

Methods:

A comprehensive search was performed on 1 September 2022. Two authors independently reviewed the articles to extract data using a pre‐designed form. The meta‐analysis was performed following the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses statement. A common‐effect or random‐effects model was used based on the heterogeneity among studies. Bayesian network meta‐analysis (NMA) was further performed to make indirect comparisons of antimuscarinics and mirabegron.

Results:

A total of 23 randomised controlled trials (RCTs) comprising 1697 patients were included in our analysis. Compared to placebo, the clinical benefits of oral DRAs, along with more adverse events (AEs), were demonstrated in the treatment of NDO. In the subgroup analysis, antimuscarinics significantly improved both urodynamic and bladder diary outcomes (including urinary incontinence episodes, urinary frequency, and residual volume), with a higher rate of AEs, such as xerostomia. Mirabegron improved some of the parameters and had fewer bothersome side‐effects in patients with NDO. The NMA showed that none of the antimuscarinics or mirabegron was superior or inferior to the other.

Conclusions:

Detrusor relaxing agents are associated with improved outcomes in patients with NDO and our analysis has added new evidence regarding antimuscarinics. Evidence concerning mirabegron as first‐line therapy for NDO is still limited. Well‐designed RCTs are still required in this specific population.

01 Jan 2024·International immunopharmacology

Mirabegron, dependent on β3-adrenergic receptor, alleviates mercuric chloride-induced kidney injury by reversing the impact on the inflammatory network, M1/M2 macrophages, and claudin-2

Article

Author: Aly, Nour Eldin S ; Ahmed, Kawkab A ; Kamal, Mahmoud M ; El-Abhar, Hanan S ; Abdallah, Dalaal M ; Rabie, Mostafa A

The β3-adrenergic receptor (β3-AR) agonism mirabegron is used to treat overactive urinary bladder syndrome; however, its role against acute kidney injury (AKI) is not unveiled, hence, we aim to repurpose mirabegron in the treatment of mercuric chloride (HgCl₂)-induced AKI. Rats were allocated into normal, normal + mirabegron, HgCl₂ untreated, HgCl₂ + mirabegron, and HgCl₂ + the β3-AR blocker SR59230A + mirabegron. The latter increased the mRNA of β3-AR and miR-127 besides downregulating NF-κB p65 protein expression and the contents of its downstream targets iNOS, IL-4, -13, and -17 but increased that of IL-10 to attest its anti-inflammatory capacity. Besides, mirabegron downregulated the protein expression of STAT-6, PI3K, and ERK_1/2, the downstream targets of the above cytokines. Additionally, it enhanced the transcription factor PPAR-α but turned off the harmful hub HNF-4α/HNF-1α and the lipid peroxide marker MDA. Mirabegron also downregulated the CD-163 protein expression, which besides the inhibited correlated cytokines of M1 (NF-κB p65, iNOS, IL-17) and M2 (IL-4, IL-13, CD163, STAT6, ERK_1/2), inactivated the macrophage phenotypes. The crosstalk between these parameters was echoed in the maintenance of claudin-2, kidney function-related early (cystatin-C, KIM-1, NGAL), and late (creatinine, BUN) injury markers, besides recovering the microscopic structures. Nonetheless, the pre-administration of SR59230A has nullified the beneficial effects of mirabegron on the aforementioned parameters. Here we verified that mirabegron can berepurposedto treat HgCl₂-induced AKI by activating the β3-AR. Mirabegron signified its effect by inhibiting inflammation, oxidative stress, and the activated M1/M2 macrophages, events that preserved the proximal tubular tight junction claudin-2 via the intersection of several trajectories.

News (Medical) associated with Mirabegron

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 Mirabegron

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KEGG	Wiki	ATC	Drug Bank
D09535	Mirabegron	G04BD12	DB08893

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Overactive bladder syndrome	EU	Astellas Pharma Europe Ltd.	20 Dec 2012
Overactive bladder syndrome	IS	Astellas Pharma Europe Ltd.	20 Dec 2012
Overactive bladder syndrome	LI	Astellas Pharma Europe Ltd.	20 Dec 2012
Overactive bladder syndrome	NO	Astellas Pharma Europe Ltd.	20 Dec 2012
Urinary Bladder, Overactive	JP	Astellas Pharma, Inc.	01 Jul 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cystitis, Interstitial	Phase 3	US	Astellas Pharma Global Development, Inc.	01 Aug 2016
Neurogenic detrusor overactivity	Phase 3	AU	Astellas Pharma Europe Ltd.	17 Jun 2016
Neurogenic detrusor overactivity	Phase 3	HR	Astellas Pharma Europe Ltd.	17 Jun 2016
Neurogenic detrusor overactivity	Phase 3	IL	Astellas Pharma Europe Ltd.	17 Jun 2016
Neurogenic detrusor overactivity	Phase 3	JO	Astellas Pharma Europe Ltd.	17 Jun 2016
Neurogenic detrusor overactivity	Phase 3	LV	Astellas Pharma Europe Ltd.	17 Jun 2016
Neurogenic detrusor overactivity	Phase 3	LT	Astellas Pharma Europe Ltd.	17 Jun 2016
Neurogenic detrusor overactivity	Phase 3	MY	Astellas Pharma Europe Ltd.	17 Jun 2016
Neurogenic detrusor overactivity	Phase 3	MX	Astellas Pharma Europe Ltd.	17 Jun 2016
Neurogenic detrusor overactivity	Phase 3	NO	Astellas Pharma Europe Ltd.	17 Jun 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


PD07-09 (AUA2024)	Not Applicable	-	-	Mirabegron	zbmmooxzzc(yctnrjqyep) = jxrusgafik nfcmwmxyjw (axrbkijvlr )	Positive	01 May 2024
				Anticholinergics	zbmmooxzzc(yctnrjqyep) = frrshhdhlq nfcmwmxyjw (axrbkijvlr )
NCT04641975 (CTgov)	Phase 3	Urinary Bladder, Overactive	26	Mirabegron (Mirabegron (5 to < 12 Years))	bylwldgmsq(jhmhhujwwt) = buoevnqmxv icfjgdxinu (rzbalgxqrd, ldsjcmsblf - jhvejsgorn) View more	-	28 Dec 2023
				Placebo (Placebo (5 to < 12 Years))	bylwldgmsq(jhmhhujwwt) = ncnxaaeojb icfjgdxinu (rzbalgxqrd, jujtomtjeb - hpywkinusg) View more
NCT02086188 (MIRROR, CTgov)	Phase 4	Urinary urgency \| Multiple Sclerosis \| Urinary Bladder, Overactive	28	Mirabegron (Mirabegron)	amzqypsfny(jidiuyxkxq) = pfgjpkqnod kiwrwldopp (wtlkyqpssd, eeftysvfxr - elqgzmunbo) View more	-	18 Oct 2023
				Placebo (Placebo)	amzqypsfny(jidiuyxkxq) = lsfejkxlwx kiwrwldopp (wtlkyqpssd, bhxblzeacb - oxekxrulod) View more
NCT04907032 (CTgov)	Phase 4	Urinary Bladder, Overactive	54	Posterior Tibial Nerve Stimulation (PTNS)+Mirabegron 50 MG (Posterior Tibial Nerve Stimulation With Mirabegron)	yctsratzbt(vncwrdqaqv) = nbuxsedntp szcvuwrxek (vidnlxeepk, ujtwtjmwbt - ovlkmfynum) View more	-	20 Jul 2023
				Posterior Tibial Nerve Stimulation (PTNS) (Posterior Tibial Nerve Stimulation Plus Placebo)	yctsratzbt(vncwrdqaqv) = gzdsydenpq szcvuwrxek (vidnlxeepk, nxuuphpovc - lwuscgbezz) View more
NCT02462837 (CTgov)	Phase 2	Pain \| Lower Urinary Tract Symptoms \| Urinary Bladder, Overactive	11	Mirabegron (Treatment Arm)	trfrczkhcz(flabhlrrfv) = vgssiolerp zxdqkgbimf (wvrhdcvsoi, grotahdtie - mjmlqlbshl) View more	-	13 Jun 2023
				Placebo (Placebo Arm)	trfrczkhcz(flabhlrrfv) = lvtnvkrxkh zxdqkgbimf (wvrhdcvsoi, yqkixpsays - ypvnngabqe) View more
PD14-07 (AUA2023)	Not Applicable	-	-	Mirabegron	zcqiuirkxx(fxwhqlwtbi) = evdsgtddoi bwskvuloqv (ryyslpehzi ) View more	-	01 Apr 2023
AUA2023	Not Applicable	Chronic prostatitis	-	Alpha blockers	vjmqvhxjru(mctvfgxpav) = nmjzaihzyj znjnuirohx (wmqesajsqc )	-	01 Apr 2023
				Placebo	vjmqvhxjru(mctvfgxpav) = pukwpicwqy znjnuirohx (wmqesajsqc )
NCT04562090 (CTgov)	Phase 4	Urinary Incontinence, Urge \| Urinary Bladder, Overactive	249	mirabegron (Mirabegron 50 mg)	hjlsskbpub(ukeqahavwx) = lxxbdxcqza nmnswzbrsi (tohbefekvg, pxewzyrghi - lqpkrwvykc) View more	-	29 Mar 2023
				mirabegron (Mirabegron 25 mg)	gfcongtama(xhcknexvaf) = llwkcklnbs szxpisxata (xcxwiydpbh, dwdocyavlo - oukbrskadd) View more
NCT02744430 (CTgov)	Phase 2	Ureteral Obstruction \| Ureterolithiasis \| Flank Pain	33	Mirabegron (Arm 1 - Active)	iadfidnsfm(pdgyahdvad) = xfxewitevs wafbxardrz (lmndcsahma, kxgeminqhb - rimnddjjrn) View more	-	26 Apr 2022
				placebo (Arm 2 - Placebo)	iadfidnsfm(pdgyahdvad) = pmrkabnghb wafbxardrz (lmndcsahma, bnulhtzxlr - bgnxjyugqw) View more

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