Defined by the International Continence Society (ICS) as urinary "urgency, with or without urge incontinence, usually with frequency and nocturia", overactive bladder (OAB) presents as challenging syndrome to treat. OAB is a very prevalent condition, affecting between 11.8% to 16% of the population with equal impact on women and men and growing prevalence with age. OAB is associated with a significant financial burden to both patients and the health care system with a estimated cost of US $82.6 billion in 2020. Traditionally, a stepwise approach has been taken in managing OAB; starting first with lifestyle modifications, followed by anticholinergic or beta-3-agonist medications as the second line, and lastly, intradetrusor onabotulinumtoxinA injections, percutaneous tibial nerve stimulation (PTNS), and sacral neuromodulation (SNM) as third line options. Given the limitations of this stepwise approach in patients with refractory OAB, combination therapy offers patients an increasing number of treatment options but the literature surrounding the efficacy of combination therapy is somewhat limited. A 2019 systematic review revealed there were only 32 studies in the current OAB literature that explored the role of combination therapy, and the majority of these studies examined the effect of lifestyle modifications with another intervention strategy, highlighting an untapped area of research5.
To date, there has only been a single pilot study conducted in Taiwan examining the effect of intradetrusor onabotulinumtoxinA injections with the addition of mirabegron for patients with refractory OAB. This study by Wang et al. explored the therapeutic impact of adding either an anticholinergic, solifenacin, or a beta-3 agonist, mirabegron, to intradetrusor onabotulinumtoxinA injections as compared to each other as well as patients receiving onabotulinumtoxinA alone. Ninety patients were enrolled with 30 patients allocated to the solifenacin arm, 31 to the mirabegron arm, and 29 to the control group. While the baseline data among the three arms was comparable, the percentage of OAB wet in the mirabegron plus onabotulinumtoxinA group was significantly less at 3-, 6-, 9-, and 12-month intervals than the solifenacin plus onabotulinumtoxinA and the onabotulinumtoxinA alone groups. While this pilot study reveals the potential additive benefit of a beta-3 agonist to intradetrusor onabotulinumtoxinA, no further studies have been performed to date and there are no studies regarding the additive benefit of vibegron, which has a more tolerable side effect profile and is not as limited by as many contraindications as mirabegron. If vibegron can potentiate the effect of intradetrusor onabotulinumtoxinA, this presents a new treatment strategy for OAB and could offer patients an additional line of therapy before having to pursue more invasive and costly management option of sacral neuro modulation.

Start Date01 Sep 2024

Sponsor / Collaborator

The University of Alabama at Birmingham

NCT06417177 / Not yet recruitingEarly Phase 1IIT

Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia

The purpose of this study is to examine hypoxic vasodilation and the role of beta-adrenergic receptors in younger premenopausal, perimenopausal, and older postmenopausal women.

Start Date01 Jun 2024

Sponsor / Collaborator

University of Missouri

JPRN-jRCT1011230058 / SuspendedNot Applicable

Comparison of efficacy and safety of tamsulosinand vibegron for male lower urinary tract symptoms-Multicenter randomized crossover study- - ALPHABET study

Start Date26 Jan 2024

Sponsor / Collaborator-

100 Clinical Results associated with Vibegron

100 Translational Medicine associated with Vibegron

100 Patents (Medical) associated with Vibegron

Literatures (Medical) associated with Vibegron

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 Dec 2023·Cureus

Chronic Penile Pain: A Poorly Researched and Managed Life-Debilitating Condition

Author: Bailon, Rachel ; Trammel, Sabrina ; Huang, Jing ; Shah, Nishma

Chronic penile pain is a complex clinical entity with limited diagnostic criteria and treatment options. Due to limited reporting of these cases, there are no clear clinical treatments and indications for when these patients present to the clinic. This case report will highlight the diagnostic challenges encountered and the subsequent management strategies employed while working up a patient with penile pain. We present a 37-year-old male with a six-year history of debilitating penile pain, urinary frequency, and urgency that is exacerbated by sexual arousal and touch. Initial evaluations attributed the symptoms to medication side effects, leading to medication changes. Despite multiple treatments, including gabapentin, solifenacin, vibegron, and a variety of specialist consultations, the patient's condition persisted. Neurological evaluation revealed pudendal neuropathy. Medical management with pudendal nerve blocks and gabapentin did not provide lasting relief, so surgical interventions were considered. Subsequent treatment with an InterStim II device (Medtronic Inc., Minneapolis, MN) initially resulted in significant symptom improvement. Unfortunately, at the seven-month follow-up, his pain returned. Further evaluation and additional treatment options are currently under consideration. This case report highlights the diagnostic complexity and limited treatment options for chronic penile pain. It suggests that sacral neuromodulation, although lacking long-term data, may offer temporary relief in cases refractory to medical therapy. Further research is needed to enhance our understanding and management of this challenging condition.

02 Nov 2023·Expert review of clinical pharmacology

Clinical pharmacology of β-3 adrenergic receptor agonists for cardiovascular diseases

Article

Author: Balligand, Jean-Luc ; Michel, Lauriane Y M

INTRODUCTION:

Few agonists of the third isotype of beta-adrenergic receptors, the β3-adrenoreceptor, are currently used clinically, and new agonists are under development for the treatment of overactive bladder disease. As the receptor is expressed in human cardiac and vascular tissues, it is important to understand their beneficial (or adverse) effect(s) on these targets.

AREAS COVERED:

We discuss the most recent results of clinical trials testing the benefit and safety of β3-adrenoreceptor activation on cardiovascular outcomes in light of current knowledge on the receptor biology, genetic polymorphisms, and agonist pharmacology.

EXPERT OPINION:

While evidence from small clinical trials is limited so far, the β3-agonist, mirabegron seems to be safe in patients at high cardiovascular risk but produces benefits on selected cardiovascular outcomes only at higher than standard doses. Activation of cardiovascular β3-adrenoreceptors deserves to be tested with more potent agonists, such as vibegron.

News (Medical) associated with Vibegron

13 May 2024

·www.prnewswire.com

Sumitomo Pharma Announces FDA Acceptance of Supplemental New Drug Application for Vibegron in Men with Overactive Bladder Symptoms Receiving Pharmacological Therapy for Benign Prostatic Hyperplasia

–Supplemental New Drug Application (sNDA) submission based on Phase 3 study of vibegron 75mg (GEMTESA) demonstrating statistically significant reductions in daily micturition and urgency episodes– –If approved, vibegron will be the first and only beta-3 agonist for the treatment of men with OAB symptoms receiving pharmacological therapy for BPH– MARLBOROUGH, Mass., May 13, 2024 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA), announced today the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for vibegron (GEMTESA®), a beta-3 adrenergic receptor (β3) agonist, dosed once-daily (75 mg), for the treatment of men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH). If approved, vibegron will be the first and only beta-3 agonist for the treatment of men with OAB symptoms receiving pharmacological therapy for BPH. The FDA has set a target action date in Q3 of FY2024, under the Prescription Drug User Fee Act (PDUFA). The sNDA is supported by the results from URO-901-3005 a Phase 3 multicenter, randomized, double-blind, parallel-group, fixed-dose study, which evaluated the efficacy, safety, and tolerability of vibegron versus placebo over 24 weeks in approximately 1,100 men with OAB symptoms receiving pharmacological therapy for BPH. The study met all co-primary endpoints at Week 12, demonstrating statistically significant reductions from baseline in the average number of micturition (urination) episodes per day and in the average number of daily urgency episodes (the sudden urge to urinate that is difficult to control) compared to placebo as well as all secondary endpoints, including reduction of nocturia episodes (awakening to use the bathroom per night) and instances of urge urinary incontinence episodes (unintentional loss of urine immediately after an urgent need to urinate) per day. Vibegron was well-tolerated throughout the study and there were no new safety signals compared to prior vibegron studies. "This milestone is important in our efforts to bring novel treatments to those living with urological conditions including OAB and BPH," said Tsutomu Nakagawa, Ph.D, President and Chief Executive Officer of SMPA. "We are pleased the FDA has recognized the strength of the Phase 3 data for vibegron in the URO-901-3005 study within our application. We look forward to working with the FDA during the review period in the hopes of potentially providing a new, safe, and effective treatment option for men struggling with OAB symptoms receiving pharmacological therapy for BPH." BPH is increasingly prevalent in men as they get older and associated symptoms of OAB can often be mistaken as a natural part of aging. Nearly half of all men between ages 51 and 60 have BPH while up to 90% of men over age 80 have BPH.1 Approximately 46% of patients with bladder outlet obstruction secondary to BPH also have OAB.2 Vibegron is currently approved for OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. About GEMTESA (vibegron) Vibegron, a once-daily beta-3 adrenergic receptor (β3) agonist, is currently under investigation for the treatment of men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia in the United States (U.S.). In the U.S., GEMTESA (vibegron) has been indicated for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults since April 2021. GEMTESA works by selectively targeting β3 adrenergic receptors to reduce OAB symptoms through the relaxation of the bladder detrusor muscle to increase capacity. In China and Europe, vibegron is currently under investigation in a Phase 3 clinical study for the treatment of OAB. About Overactive Bladder Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), and frequent urination (usually eight or more times in 24 hours).3 About 33 million U.S. adults experience the bothersome symptoms of OAB.4 About Benign Prostatic Hyperplasia Benign prostatic hyperplasia (BPH) is a condition in men in which the prostate gland is enlarged. About 60% of men with BPH are treated for lower urinary tract symptoms (LUTS).5,6 LUTS can be divided into storage, voiding, and postmicturition symptoms.7 Over half of men with BPH report storage symptoms and about a quarter report voiding symptoms.6 This suggests that many men with a diagnosis of BPH may have overactive bladder.6 Many men who are treated for symptoms are assumed to have an obstruction in the bladder caused by an enlarged prostate.5,6 About half of all men between ages 51 and 60 have BPH and up to 90% of men over age 80 are living with the condition.1 INDICATIONS AND USAGE GEMTESA is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of the product. WARNINGS AND PRECAUTIONS Urinary Retention Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction and patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention. ADVERSE REACTIONS Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. Please see full Prescribing Information . About Sumitomo Pharma Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn. SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd. GEMTESA is a trademark of Urovant Sciences GmbH, and registered in the U.S., and in other countries. © 2024 Sumitomo Pharma America, Inc. All rights reserved. References Prostate Enlargement (Benign Prostatic Hyperplasia). National Institute of Diabetes and Digestive and Kidney Diseases. September 2014. Herschorn S, McVary K, Santos J, Foley S, Kristy R, Choudhury N, Hairston J, Kaplan S. Mirabegron Vs Placebo Add-on Therapy in Men With Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: A Safety Analysis From the Randomized, Phase 4 PLUS Study. Urology, volume 147, p235-242, January 2021. Published online 2020 October 09. doi: Overactive bladder – symptoms and causes. Mayo Clinic. 2022. Accessed August 25, 2023. Gomelsky A. Update on the management of overactive bladder: patient considerations and adherence. Journal of Urology. Open Access J Urol. 2011; 3: 7–17. Published online 2010 Dec 30. doi: 10.2147/OAJU.S7233 Burnett AL, Walker DR, Feng Q, Johnston KM, Lozano-Ortega G, Nimke D, Hairston JC. Undertreatment of overactive bladder among men with lower urinary tract symptoms in the United States: A retrospective observational study. Neurourol Urodyn. 2020 Jun;39(5):1378-1386. doi: 10.1002/nau.24348. Epub 2020 May 8. PMID: 32383533; PMCID: PMC7384148. Anger, JT, Goldman, HB, Luo, X, et al. Patterns of medical management of overactive bladder (OAB) and benign prostatic hyperplasia (BPH) in the United States. Neurourology and Urodynamics. 2018; 37: 213–222. Lepor H. Pathophysiology of lower urinary tract symptoms in the aging male population. Rev Urol. 2005;7 Suppl 7(Suppl 7):S3-S11. PMID: 16986059; PMCID: PMC1477625. SOURCE Sumitomo Pharma America

Phase 3Clinical ResultDrug ApprovalNDA

07 May 2024

·www.prnewswire.com

Sumitomo Pharma Presents Urology and Oncology Data at AUA 2024 Annual Meeting

–Data includes results from Phase 3 study of vibegron 75mg (GEMTESA) in men living with overactive bladder receiving pharmacological treatment for benign prostatic hyperplasia– MARLBOROUGH, Mass., May 7, 2024 /PRNewswire/ -- Sumitomo Pharma America, Inc., (SMPA) today announced the presentation of data from URO-901-3005, a Phase 3 randomized, double-blind, parallel-group, fixed-dose study evaluating the efficacy, safety, and tolerability of vibegron (GEMTESA®) versus placebo over 24 weeks in men living with overactive bladder (OAB) and receiving pharmacological therapy for benign prostatic hyperplasia (BPH) at the American Urological Association (AUA) Annual Meeting. Following the podium presentation at AUA, these results were published in Journal of Urology. Continue Reading Approximately 1,100 men with OAB symptoms receiving pharmacological therapy for BPH participated in URO-901-3005. The results found that treatment with vibegron (75 mg a day) was associated with statistically significant, clinically meaningful improvements in all co-primary and secondary endpoints. At Week 12, statistically significant reductions were observed from baseline (least squares means) in the average number of micturition (urination) episodes per day (-2.04 [SE: 0.109]; p<0.0001) and in the average number of daily urgency episodes (-2.88 [SE: 0.164]; p<0.0001) compared to placebo (-1.30 [SE: 0.109] and -1.93 [SE: 0.164], respectively). Improvements in co-primary efficacy parameters were observed by Week 2 and maintained through Week 24 of the trial. "There is currently no approved treatment for persistent OAB symptoms in men who are receiving treatment for BPH. We are happy to share these results with the scientific community at AUA." Post this Vibegron met all secondary endpoints at Week 12, including significant reductions versus placebo across secondary endpoints including daily nocturia episodes (-0.88 compared to -0.66; p=0.0015), urge urinary incontinence (UUI) episodes (-2.19 compared to -1.39; p=0.0034) and international prostate symptom score (IPSS)-storage score (-3.0 compared to -2.1; p<0.0001), and a significant increase versus placebo in volume voided per micturition (25.63 mL compared to 10.56 mL; p<0.0001). Once daily 75 mg vibegron was well-tolerated throughout the study and demonstrated a consistent safety profile, that was comparable to placebo, with no new safety signals compared to prior OAB studies. "The results from the Phase 3 study build on the body of evidence we have outlining the safety, efficacy and tolerability of vibegron as a treatment of the symptoms associated with OAB and now for men receiving pharmacological treatments for benign prostatic hyperplasia experiencing symptoms of OAB," said Janet Owens-Grillo, Ph.D., M.S., Executive Director, Clinical Research at SMPA. "There is currently no approved treatment for persistent OAB symptoms in men who are receiving treatment for BPH. We are happy to share these results with the scientific community at AUA." Quality of life was assessed during the Phase 3 study via the overactive bladder questionnaire (OAB-q) long form, comprising the symptom bother subscale score and the HRQL total score (including coping, concern, sleep, and social interaction subscores), with 1-week recall. Results presented indicated that vibegron was associated with significant improvements from baseline in OAB-q scores versus placebo at Week 12 and Week 24 (P<0.0001). Use of GEMTESA® (vibegron) in men with symptoms of OAB receiving pharmacological therapy for BPH is not approved and its safety and efficacy have not been evaluated by regulatory authorities. SMPA also co-presented, in alliance with Pfizer, a poster on the results of a discrete choice experiment looking at whether patients with advanced prostate cancer had a preference between oral and injectable androgen deprivation therapy (ADT). The results suggest that patients are amenable to an oral option, irrespective of prior experience with injectable alternatives. The findings highlight the need for further education on different treatment options, as well as bidirectional communication between patients and providers to determine the best option for each patient. "SMPA is committed to scientific and therapeutic advancements on behalf of patients where limited or no options exist," said Adele Gulfo, Chief Executive Officer, Biopharma Commercial Unit at SMPA. "We are proud to have our urology and oncology teams together and among the leaders at AUA sharing positive data that underpins our steadfast commitment to those living with unmet urological conditions." About GEMTESA (vibegron) Vibegron, a once-daily beta-3 adrenergic receptor (β3) agonist, is currently under investigation for the treatment of men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia in the United States (U.S.). In the U.S., GEMTESA (vibegron) has been indicated for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults since April 2021. GEMTESA works by selectively targeting β3 adrenergic receptors to reduce OAB symptoms through the relaxation of the bladder detrusor muscle to increase capacity. In China, vibegron is currently under investigation in a Phase 3 clinical study for the treatment of OAB. About Overactive Bladder Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), and frequent urination (usually eight or more times in 24 hours).1 About 33 million U.S. adults experience the bothersome symptoms of OAB.2 About Benign Prostatic Hyperplasia Benign prostatic hyperplasia (BPH) is a condition in men in which the prostate gland is enlarged. About 60% of men with BPH are treated for lower urinary tract symptoms (LUTS).3,4 LUTS can be divided into storage, voiding, and postmicturition symptoms.5 Over half of men with BPH report storage symptoms and about a quarter report voiding symptoms.4 This suggests that many men with a diagnosis of BPH may have overactive bladder.4 Many men who are treated for symptoms are assumed to have an obstruction in the bladder caused by an enlarged prostate.3,4 About half of all men between ages 51 and 60 have BPH and up to 90% of men over age 80 are living with the condition.6 INDICATIONS AND USAGE GEMTESA is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of the product. WARNINGS AND PRECAUTIONS Urinary Retention Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction and patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention. ADVERSE REACTIONS Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. Please see full Prescribing Information. About Sumitomo Pharma Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information, please visit and follow us on LinkedIn. SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd. GEMTESA is a trademark of Urovant Sciences GmbH, and registered in the U.S., and in other countries. © 2024 Sumitomo Pharma America, Inc. All rights reserved. References Overactive bladder – symptoms and causes. Mayo Clinic. 2022. Accessed August 25, 2023. Gomelsky A. Update on the management of overactive bladder: patient considerations and adherence. Journal of Urology. Open Access J Urol. 2011; 3: 7–17. Published online 2010 Dec 30. doi: 10.2147/OAJU.S7233 Burnett AL, Walker DR, Feng Q, Johnston KM, Lozano-Ortega G, Nimke D, Hairston JC. Undertreatment of overactive bladder among men with lower urinary tract symptoms in the United States: A retrospective observational study. Neurourol Urodyn. 2020 Jun;39(5):1378-1386. doi: 10.1002/nau.24348. Epub 2020 May 8. PMID: 32383533; PMCID: PMC7384148. Anger, JT, Goldman, HB, Luo, X, et al. Patterns of medical management of overactive bladder (OAB) and benign prostatic hyperplasia (BPH) in the United States. Neurourology and Urodynamics. 2018; 37: 213–222. Lepor H. Pathophysiology of lower urinary tract symptoms in the aging male population. Rev Urol. 2005;7 Suppl 7(Suppl 7):S3-S11. PMID: 16986059; PMCID: PMC1477625. Benign Prostatic Hyperplasia (BPH). Urology Care Foundation. 2021. Accessed August 25, 2023. (bph) SOURCE Sumitomo Pharma America

Clinical ResultPhase 3Drug Approval

29 Apr 2024

·www.pharmaceutical-technology.com

Pierre Fabre’s vibegron gains CHMP positive opinion for OAB

Vibegron has shown a favourable risk-benefit profile in treating urgency. Credit: SewCreamStudio/Shutterstock.com. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion and recommended the approval of Pierre Fabre Laboratories’ OBGEMSA (vibegron) for overactive bladder syndrome (OAB) in adults. Vibegron is a potent and selective human beta-3 adrenergic receptor (β3-AR) agonist. The positive opinion is a significant step towards marketing authorisation from the European Commission for OBGEMSA. The decision impacts all member states of the European Union along with Liechtenstein, Iceland and Norway. The endorsement is based on positive data from two Phase III studies which demonstrated vibegron’s efficacy and safety over 12 and 52 weeks. In the pivotal, randomised, multicentre and double-blind studies, Vibegron showed a favourable risk-benefit profile in treating the urgency, increased micturition [urination] and urge urinary incontinence associated with OAB. See Also: Corcept Therapeutics gets grant for treating antipsychotic-induced weight gain with miricorilant Merus gets grant for treatment of CLEC12a positive cancer with bispecific antibody The CHMP opinion also considered data from a Phase I study, confirming vibegron’s lack of significant effects on blood pressure or heart rate. Vibegron is already approved in the US, Japan and the Republic of Korea. Pierre Fabre Laboratories CEO Eric Ducournau stated: “We are very pleased to have received this positive opinion from the CHMP for OBGEMSA. “If approved, this innovative therapeutic solution has the potential to help patients suffering from overactive bladder, a condition that is very debilitating in daily life. We have been working in the field of urology for more than 40 years and OBGEMSA is proof of our determination to continue our development in this area.” Last year, Atara divested its marketing rights to Ebvallo (tabelecleucel) in North America, Asia Pacific and Latin America to Pierre Fabre for $640m.

Clinical ResultDrug ApprovalPhase 3Phase 1

100 Deals associated with Vibegron

External Link

KEGG	Wiki	ATC	Drug Bank
D10433	-	G04BD	DB14895

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pollakisuria	US	Urovant Sciences, Inc.	23 Dec 2020
Urinary Incontinence, Urge	US	Urovant Sciences, Inc.	23 Dec 2020
Urinary Bladder, Overactive	JP	KYORIN Pharmaceutical Co., Ltd.	21 Sep 2018
Urinary Bladder, Overactive	JP	Kissei Pharmaceutical Co., Ltd.	21 Sep 2018

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Overactive bladder syndrome	NDA/BLA	EU	Pierre Fabre Médicament SAS	25 Apr 2024
Neurogenic detrusor overactivity	Phase 3	US	Urovant Sciences Ltd.	12 Oct 2022
Prostatic Hyperplasia	Phase 3	US	Urovant Sciences Ltd.	26 Mar 2019
Prostatic Hyperplasia	Phase 3	BE	Urovant Sciences Ltd.	26 Mar 2019
Prostatic Hyperplasia	Phase 3	CA	Urovant Sciences Ltd.	26 Mar 2019
Prostatic Hyperplasia	Phase 3	HU	Urovant Sciences Ltd.	26 Mar 2019
Prostatic Hyperplasia	Phase 3	LT	Urovant Sciences Ltd.	26 Mar 2019
Prostatic Hyperplasia	Phase 3	PL	Urovant Sciences Ltd.	26 Mar 2019
Prostatic Hyperplasia	Phase 3	PT	Urovant Sciences Ltd.	26 Mar 2019
Prostatic Hyperplasia	Phase 3	ES	Urovant Sciences Ltd.	26 Mar 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03902080 (URO-901-3005, PRNewswire) Manual	Phase 3	Urinary Bladder, Overactive	-	Vibegron 75mg (GEMTESA)	foovuqhqkx(kokcqfqtjz) = rcahonwgnq nqctzvenii (oczywakmrw, 0.109) View more	Positive	07 May 2024
NCT03492281 (EMPOWUR, Pubmed) Manual	Phase 3	Urinary Bladder, Overactive	922	Vibegron	xuzwjrszii(gwndsblfcg): difference = -0.5 (95% CI, -0.8 to -0.2) View more	Positive	21 Nov 2022
				Placebo
AUA2022	Not Applicable	Bladder dysfunction \| Spinal Dysraphism Adjuvant	19	Vibegron	ixmrbrbvdw(brlkoqhqoo) = lgjycmmfbh jrbgayfgxh (mmwslqqohm )	-	01 May 2022
				Antimuscarinic therapy	ixmrbrbvdw(brlkoqhqoo) = vzakohfakc jrbgayfgxh (mmwslqqohm )
NCT03492281 (EMPOWUR, Pubmed \| Adv Ther) Manual	Phase 3	Urinary Bladder, Overactive	-	vibegron	dagogukagl(mbdbdfdvpn) = tsvmkxjdhg yfqmrixczt (umnloctgdu ) View more	Positive	18 Dec 2021
				Placebo	dagogukagl(mbdbdfdvpn) = spauxfixcr yfqmrixczt (umnloctgdu ) View more
NCT03806127 (CTgov)	Phase 2	Irritable Bowel Syndrome	222	Placebo (Placebo)	dzkstazmjf(jskeoyukth) = avqgpedxrn ejguoksxvr (dhllcoxqkq, enyjvsnrur - ogmcercubp) View more	-	30 Jul 2021
				Vibegron (Vibegron 75 mg)	dzkstazmjf(jskeoyukth) = fygmwqfdsh ejguoksxvr (dhllcoxqkq, soxlwegzrw - kttjojmclh) View more
NCT03583372 (Pubmed \| J Urol) Manual	Phase 3	Urinary Bladder, Overactive	506	vibegron	qzrxqoceof(deciplwxhf) = esuulcberk jomnpcjsrq (grgrdzigoi ) View more	Positive	01 May 2021
				tolterodine	rutiurpzms(vnagisfohb) = lwdvfaeoxg kldhhdcunv (fanrxkmcup ) View more
NCT03492281 (EMPOWUR, CTgov)	Phase 3	Urinary Bladder, Overactive	1,530	placebo (Placebo)	lebecsenka(xaafjciyes) = qjopyygdye loycrdaemj (oqjyocxnvm, ledbiljxqb - ekuluammag) View more	-	04 Mar 2021
				Vibegron (Vibegron 75 mg)	lebecsenka(xaafjciyes) = evckrcvkcv loycrdaemj (oqjyocxnvm, lkgdsuhnus - klchfktiyk) View more
NCT03583372 (CTgov)	Phase 3	Urinary Bladder, Overactive	506	Vibegron (Overall Vibegron 75 mg)	dqbdnuecjs(bjemhoxfrf) = vuufzgoldq dnnuldekms (driqrgbsel, ryzsxzptqs - aofnqfwilz) View more	-	03 Feb 2021
				Tolterodine (Overall Tolterodine ER 4 mg)	dqbdnuecjs(bjemhoxfrf) = ikmqosarzu dnnuldekms (driqrgbsel, kpjvkswazb - btymsjdwmu) View more
NCT03492281 (EMPOWUR, Pubmed \| Drugs Aging)	Phase 3	Urinary Bladder, Overactive	1,463	Vibegron 75 mg	pvstummtgo(itbnndbztn) = aferofqakj kqpgmirjue (xxrsbbncyv )	-	01 Feb 2021
				Placebo	pvstummtgo(itbnndbztn) = btavcdyoql kqpgmirjue (xxrsbbncyv )

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