Date: 2016-09-19
Type of information: Granting of a Market Authorisation in the EU
Product name: Viberzi® (US)/Truberzii® (UE)
Compound: eluxadoline
Therapeutic area: Gastrointestinal diseases - Digestive diseases
Action mechanism: Eluxadoline is a mu receptor agonist, a delta receptor antagonist, and a kappa receptor agonist.
Company: Actavis, now Allergan (Ireland) Aptalis Pharma (France)
Disease: irritable bowel syndrome with diarrhea
Latest news: * On 21 July 2016, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, * On December 14, 2015, Allergan announced that Viberzi® (eluxadoline) is now available by prescription in the U.S.
recommending the granting of a marketing authorisation for Truberzi®, intended for the treatment of adults with irritable bowel syndrome with diarrhoea (IBS-D). Truberzi® will be available as 75 and 100 mg film-coated tablets.
The benefits with Truberzi® in patients with IBS-D are its ability to increase days with no diarrhoea and to improve pain. The rate of patients with no diarrhoea and reduced pain for at least 50% of the days over a 26 week period was about 11.5 percentage points higher with Truberzi® 100 mg than with placebo, whereas the difference was about 7 percentage points with Truberzi® 75 mg. The most common side effects are constipation (7% and 8% of patients receiving 75 mg and 100 mg respectively), nausea (8% and 7% of patients receiving 75 mg and 100 mg respectively) and abdominal pain/abdominal distension (7% and 7% of patients receiving 75 mg and 100 mg respectively). Serious adverse reactions include pancreatitis (0.2% and 0.3% of patients receiving 75 mg and 100 mg respectively) and sphincter of Oddi spasm (0.2% of patients receiving 75 mg and 0.8% of patients receiving 100 mg).
On November 12, 2015 , the Drug Enforcement Agency (DEA) completed its review of Viberzi®(eluxadoline), and published its Final Rule placing Viberzi® into Schedule IV of the Controlled Substance Act. Schedule IV drugs, substances, or chemicals are defined by the DEA as drugs with a low potential for abuse and low risk of dependence.
* On May 27, 2015, the FDA approved Viberzi® (eluxadoline) for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women. Viberzi®, which contains a new active ingredient, is taken orally twice daily with food. Viberzi activates receptors in the nervous system that can lessen bowel contractions. The safety and effectiveness of Viberzi® for treatment of IBS-D were established in two double-blind, placebo-controlled clinical trials in which 2,425 patients were randomly assigned to receive Viberzi® or placebo. Results showed Viberzi® was more effective in simultaneously reducing abdominal pain and improving stool consistency than placebo over 26 weeks of treatment. The most common side effects in patients treated with Viberzi® include constipation, nausea and abdominal pain. The most serious known risk associated with Viberzi® is the risk of spasm in the sphincter of Oddi, the smooth muscle that surrounds the end portion of the common bile and pancreatic ducts, which can result in pancreatitis. Viberzi® should not be used in patients with a history of bile duct obstruction, pancreatitis, severe liver impairment, or severe constipation, and in patients who drink more than three alcoholic beverages per day.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2015-05-27
UE authorization: 2016-09-19
Favourable opinion UE: 2016-07-21
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
