Tolterodine Tartrate

CASTRES, France , April 26, 2024 /PRNewswire/ -- Pierre Fabre Laboratories announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of OBGEMSA™ (vibegron under the international non-proprietary name) for the symptomatic treatment of adult patients with overactive bladder syndrome (OAB). Pierre Fabre Laboratories acquired an exclusive license from Urovant Sciences to register and commercialize vibegron in the European Economic Area in 2022. OBGEMSA™ is a trademark owned by Urovant Sciences GmbH. The CHMP recommendation will now be reviewed by the European Commission (EC), which may decide on the marketing authorisation (MA) for OBGEMSA™ (vibegron). The decision will then be applicable to all member states of the European Union as well as to Iceland, Liechtenstein and Norway. " 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." said Eric DUCOURNAU, CEO of Pierre Fabre Laboratories. The CHMP positive opinion is based on positive data from two Phase 3 pivotal, randomized, multicenter and double-blind studies in patients with symptoms of overactive bladder. Study RVT-901-3003 assessed the efficacy, tolerability and safety at 12 weeks of vibegron (at a dose of 75 mg/daily) compared to placebo and tolterodine (as positive control). Its extension, Study RVT-901-3004, assessed the long-term safety, tolerability and efficacy of vibegron at 52 weeks versus tolterodine. In these studies, vibegron, as a new beta-3 adrenergic receptor (ß3 AR) agonist, demonstrated a favourable risk-benefit profile in the symptomatic treatment of urgency, increased micturition and urge urinary incontinence (UUI) that may occur in patients with OAB syndrome. The CHMP positive opinion is also supported by clinical data from the study URO-901-1001, a randomized, Phase 1, double-blind, placebo-controlled, parallel-group study in subjects with OAB, designed to study the effect of vibegron (at a dose of 75 mg daily or placebo once daily) for a duration of 28 days at steady state on ambulatory blood pressure (BP) and heart rate (HR). Results from this study confirm that vibegron 75 mg had no statistically significant or clinically meaningful effects on Blood Pressure or Heart Rate in patients with symptoms of OAB. About overactive bladder (OAB) The OAB syndrome is clinically characterized by urinary urgency (i.e. a sudden compelling desire to void that is difficult to defer), with or without urge urinary incontinence UUI, and usually accompanied by urinary frequency and nocturia in the absence of urinary tract infection or other obvious pathology. UUI is the involuntary loss of urine accompanied by urgency. UUI is distinguished from stress urinary incontinence, which is the involuntary loss of urine on effort or physical exertion (e.g., sporting activities), or on sneezing or coughing. When both components are present, the classification is mixed urinary incontinence, with either urgency or stress specified as the predominant component. From a pathophysiological perspective, the OAB symptom complex is suggestive of detrusor overactivity, which may be intrinsic or may be secondary to neurological conditions such as stroke or spinal cord injury. About vibegron Vibegron is a novel, potent, and selective human beta-3 adrenergic receptor (β3-AR) agonist. Beta receptors are found throughout the body, but β3-ARs are predominantly found on human detrusor smooth muscle. β3-ARs agonists bind to and activate beta-3 receptors on the detrusor muscle, leading to relaxation of the detrusor muscle to increase vesical capacity and to reduce OAB symptoms. Vibegron received approval in the U.S. in December 2020 (at 75 mg once daily, under the tradename GEMTESA®) for the treatment of OAB with symptoms of UUI, urgency, and urinary frequency in adults and in Japan and in the Republic of Korea, respectively in September 2018 and in October 2022 (at 50 mg once daily, under the tradename BEOVA®) for the treatment of OAB in adults. GEMTESA is a trademark of Urovant Sciences GmbH, and registered in the U.S., and in other countries. In the U.S., GEMTESA is marketed by Sumitomo Pharma America, Inc. About Pierre Fabre Laboratories For more information, visit , @PierreFabreGroup. PRESS CONTACT : PIERRE FABRE Anne Kerveillant, [email protected] Logo - SOURCE Pierre Fabre

BALTIMORE, Sept. 14, 2023 /PRNewswire/ -- Today the American Urological Association (AUA) released the 2023 clinical practice guideline amendment for the management of lower urinary tract symptoms attributed to benign prostatic hyperplasia. Benign prostatic hyperplasia (BPH) is a histologic diagnosis that refers to the production of smooth muscle and epithelial cells within the prostatic transition zone. The prevalence and the severity of lower urinary tract symptoms (LUTS) in the aging male can be progressive and is an important diagnosis in the healthcare of patients and the welfare of society . This guideline was reviewed through the AUA Update Literature Review (ULR) process and subsequently amended based on the availability of new literature, including: New section on "Legacy Technologies." New studies added for combination therapy using tolterodine/doxazosin versus combined mirabegron/doxazosin and silodosin versus PDE-5. New statement on combination of low-dose daily tadalafil 5mg with finasteride. 60-month data added for water vapor thermal therapy. Updates to the Prostatic Artery Embolization (PAE) statement and supporting text. New statement on temporary implanted prostatic devices (TIPD). "In addressing troublesome LUTS, healthcare providers must acknowledge the intricate interplay among the bladder, bladder neck, prostate, and urethra," said Dr. Jaspreet S. Sandhu, MD, a urologic surgeon at Memorial Sloan Kettering Cancer Center. "This updated guideline aims to serve as a valuable resource for the proficient and evidence-based management of LUTS/BPH." This amendment is an update from the 2021 guideline that originally covered the topic. It was distributed to peer reviewers of varying backgrounds as part of the AUA's extensive peer review process before being approved by the AUA Board of Directors. The full updated guideline is now available at auanet.org/BPHGuideline A summary of the Guideline also appears at: Sandhu JS, Bixler BR, Dahm P, et al. Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH): AUA Guideline amendment 2023. J Urol. 2023;10.1097/JU.0000000000003698. Please use this reference to cite the guideline. About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is a leading advocate for the specialty of urology, and has more than 23,000 members throughout the world. The AUA is a premier urologic association, providing invaluable support to the urologic community as it pursues its mission of fostering the highest standards of urologic care through education, research and the formulation of health policy. Contact: Corey Del Bianco, Corporate Communications & Media Relations Manager 443-909-4033, [email protected] SOURCE American Urological Association