乐动体育announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of once-daily 75mg vibegron for the treatment of patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
The NDA for vibegron is supported by an extensive clinical development program, which included data from the pivotal phase 3 , results of which were in March of 2019. The international, double-blind, placebo-controlled, multicenter trial evaluated the efficacy and safety of vibegron 75mg in adults with symptoms of OAB. Vibegron met both co-primary endpoints demonstrating highly significant reduction in daily urge urinary incontinence episodes and micturitions, compared to placebo. All seven key secondary endpoints were also reached, including a clinically meaningful reduction in daily urgency episodes versus placebo. Vibegron achieved rapid onset at two weeks in both co-primary endpoints and daily urgency episodes and statistically significant efficacy was maintained at all timepoints measured through the end of the study.
乐动体育Vibegron is a once-daily beta-3 adrenergic agonist. The beta-3 adrenergic receptor is the most prevalent beta-adrenergic receptor subtype on the smooth muscle around the bladder. Bladder filling involves the relaxation of this muscle and the contraction of the urethral smooth muscle, while voiding involves contracting the bladder muscle and relaxation of the urethral muscle. Studies of isolated human bladder smooth muscle have shown that selective activation of the beta-3 adrenergic receptor results in smooth muscle relaxation. Therefore, beta-3 stimulation can increase bladder capacity and reduce the symptoms of OAB.
乐动体育Overactive Bladder (OAB) is a clinical condition characterized by the sudden urge to urinate that is difficult to control, referred to as urgency, with or without accidental urinary leakage, and usually with increased frequency of urination. Accidental urinary leakage resulting from urgency is referred to a urge urinary incontinence (UUI). More than 30 million Americans over the age of 40 suffer from bothersome symptoms of OAB. Anticholinergic drugs have been the standard of pharmacologic care for OAB. However, anticholinergics are associated with poor tolerability and increasing safety concerns.Source: