Hetero's Generic Eluxadoline Receives Approval in the U.S.
Sun Pharma's Generic Eluxadoline Receives Approval in the US
Zydus Cadila’s US subsidiary Zydus Pharmaceuticals (USA) Inc has nreceived tentative approval from the US Food and Drug Administration n(FDA) to market Eluxadoline tablets in the strengths of 75 mg and 100 nmg, the company notified via a statement.
FDA Confirms Paragraph IV Patent Challenge of Viberzi 206940 (Eluxadoline) Tablets 75 mg and 100 mg
Allergan plc (NYSE: AGN) announced additional results of a prespecified prospective pooled subgroup analysis from the two Phase 3 studies (IBS-3001 and IBS-3002), which evaluated the efficacy and safety of Viberzi in nearly 2,500 IBS-D patients, of whom 36 percent reported use of loperamide in the 12 months prior to study randomization. These data demonstrate Viberzi® (eluxadoline) safely and effectively treats the IBS-D symptoms of abdominal pain and diarrhea irrespective of prior use of loperamide.1 These analyses also demonstrated efficacy and safety in patients with loperamide rescue medication use compared to the overall population during the two studies. The American Journal of Gastroenterology published these results, Eluxadoline Efficacy in IBS-D Patients Who Report Prior Loperamide Use, in the June issue.
Following the death of two patients without a gallbladder on Allergan’s irritable bowel drug Viberzi (eluxadoline), the US Food and Drug Administration (FDA) on Wednesday warned about the increased risk of serious pancreatitis in such patients.
Allergan CEO Brent Saunders is tired of hearing from investors that chin-fat buster Kybella’s launch isn’t going as well as, say, that of IBS-D med Viberzi or schizophrenia treatment Vraylar. So in a Monday presentation at the J.P. Morgan Healthcare Conference, he did his best to set the record straight.
The plan? Rev up growth in the underperforming GI business by adding reps who will focus on potential primary care physician prescribers of IBS-D med Xifaxan and oral opioid-induced constipation med Relistor, Valeant said this week. The way the company sees it, it can reach “a significant majority” of likely Xifaxan and oral Relistor PCPs with the effort, which it will roll out “over the coming weeks.”
According to new survey results, patients could use the help on that front: 65% of those afflicted with IBS-D experience GI symptoms for at least a year before speaking with a physician, and 46% wait at least three years. And Dixon counts herself among those who waited longer than they needed to.