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Find Clinical Drug Development Pipelines & Deals | PipelineProspector
Fesoterodine Fumarate Extended-Release Tablets, a therapeutic generic equivalent to Toviaz® (fesoterodine fumarate) Extended-Release Tablets, a muscarinic antagonist indicated for the treatment of overactive bladder.
Finasteride and tadalafil combination is used to treat men with benign prostatic hyperplasia (BPH). Tadalafil is a PDE5 inhibitor and finasteride blocks the action of 5-alpha-reductase which will increase testosterone levels in the body, which decreases prostate size.
The FDA approval is based on data from a randomized, double-blind Phase 3 study evaluating the safety and efficacy of BOTOX® in more than 100 pediatric patients with neurogenic detrusor overactivity and a long-term extension study.
The acquisition transforms the Company into a broader pharmaceutical company spanning multiple sectors by including ENTADFI (finasteride), an oral, once daily treatment for BPH that combines finasteride, a 5α-reductase inhibitor, and tadalafil, a PDE5 inhibitor.
KYORIN will grant Sumitomo Pharma the exclusive rights to develop, manufacture, and commercialize the therapeutic agent for OAB called Vibegron in in Taiwan and Other Asian Countries, and Sumitomo Pharma will develop, manufacture, and commercialize the Compound.
Solifenacin succinate is a muscarinic 3 receptor antagonist which works to decrease bladder activity by inhibiting contraction of the smooth muscle wall surrounding the bladder.
GEMTESA (vibegron) 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.
Urovant Sciences and Pierre Fabre will share responsibility for Gemtesa (vibegron), clinical trials in the pediatric populations in Europe. As part of the transaction, Urovant Sciences will also provide manufacturing services to Pierre Fabre.
In a subgroup analysis of adults, 65 years old or above with overactive bladder, treatment with GEMTESA (Vibegron) was safe and well-tolerated. Treatment with GEMTESA was associated with sustained reductions from baseline in average daily micturition.
Post-hoc analysis indicates significant reductions in urgency episodes and micturitions in patients treated with GEMTESA vs. placebo in both types of overactive bladder (OAB).
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