New drug for irritable bowel syndrome (IBS)! β-3 epinephrine-can-pertasive agitant vibegron to treat IBS-related abdominal pain phase 2 clinical failure!

November 29, 2020 // -- Urovant Sciences recently published the top-line results of a clinical study evaluating vibegron's treatment of irritable bowel syndrome (IBS) pain phase 2a.
This was a randomized, double-blind, placebo-controlled clinical trial in female patients with irritable bowel syndrome (IBS) abdominal pain accompanied by IBS-D (diarrhea) and IBS-M (mixed IBS) and assessed the efficacy and safety of vibegron (75 mg) once a day.
the study included 222 female IBS patients at 35 clinical centers in the United States and 189 completed a 12-week study.
the study, respondents were defined as "the most severe abdominal pain in the last 24 hours" and were at least 30 percent lower than the weekly baseline average over a 12-week period.
results showed that in the main efficacy analysis, the study did not reach the main endpoint: 40.9 percent of IBS-D patients treated with vibegron after 12 weeks of treatment improved by at least 30 percent over 12 weeks, compared with 42.9 percent in the placebo group.
most important secondary endpoint showed that in week 12, the global improvement scale (GIS) response rate for IBS-D patients in the vibegron group was 42.4% and the placebo group was 33.3%, but this was not statistically significant in IBS-D, IBS-M, or the IBS population as a whole.
Urovant will continue to analyze all the data sets in this study.
the study, vibegron was well-to-do and did not lead to a worsening of IBS symptoms.
the vibegron group had a 0% stoppage rate due to adverse events and 2.7% in the placebo group.
the rates of severe adverse events in each treatment group were similar, with one severe adverse reaction each in the placebo group and the vibegron group, which the researchers believed were not related to the treatment.
vibegron reported adverse events in the placebo range (both groups were 33.3%).
in particular, the adverse events of irritable bowel syndrome in vibegron and placebo groups were 2.7 per cent, respectively, and the incidence of diarrhoeal adverse events in the 75mg vibegron group and placebo group was 0 per cent and 1.8 per cent, respectively.
IBS-related abdominal pain (photo source: qhms.com) Irritable bowel syndrome (IBS) is a group of persistent or intermittent seizures that change clinically with abdominal pain, bloating, bowel habits and/or stool symptoms, but lack gastrointestinal structure and abnormal intestinal dysfunction.
typical symptoms are abdominal pain and bloating associated with abnormal detocation, which are divided according to the main symptoms: diarrhea-led type;
, diet, cold and other factors can induce symptoms to relapse or worsen.
, about 30-40 million people in the U.S. have IBS symptoms, 30 percent of whom consult a doctor.
about 80 percent of patients use pain as a symptom of their IBS severity, and an estimated 7.2-9.6 million IBS patients have IBS-related pain.
for constipation-type irritable bowel syndrome and diarrhea-type irritable bowel syndrome, there are already therapeutic drugs on the market, but these drugs do not adequately address IBS-related pain.
, there are no drugs on the market specifically for IBS-related pain.
vibegron chemical structure (Photo source: newdrugapprovals.org) vibegron is a daily β-3 epinephrine-energy agitation agent developed to treat bladder hyperactive disorder (OAB) in patients with benign prostate hyperplus (OAB) and to treat abdominal pain associated with irritable bowel syndrome (IBS).
, vibegron's application for a new drug for OAB is currently under review by the FDA, with the prescription drug user charge law (PDUFA) targeting a target date of December 26, 2020.
approved, vibegron would be the first new brand of prescription drug to treat OAB in nearly a decade.
vibegron treatment of OAB NDA, based on the support of an extensive clinical development program involving more than 4,000 OAB patients.
in a key efficacy and safety study, 75mg vibegron once a day reached the end of all major and critical secondary efficacy and showed good safety.
Origin: Urovant Sciences Announces Topline Data from Phase 2a Study of Vibegron for The Treatment of Irritable Syndrome (IBS) Pain Not Meet Primary Endpoint