DUBLIN, Dec. 14, 2015 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, announced today that VIBERZI™ (eluxadoline), the company's first-in-class treatment for irritable bowel syndrome with diarrhea (IBS-D), is now available by prescription in the U.S.
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"We are excited about the launch of VIBERZI, which addresses an unmet need among IBS-D patients seeking a treatment to manage their symptoms proactively," said William Meury, President and Executive Vice President, Branded Pharma at Allergan. "This introduction reaffirms Allergan's commitment to providing a new treatment option that serves to help gastroenterologists reach better outcomes for their patients."
IBS-D is a multifactorial disorder marked by recurrent abdominal pain or discomfort and diarrhea that affects as many as 15 million adult Americans, impacting both women and men equally.,[ii],[iii] There are few prescription treatment options available for IBS-D, particularly options that relieve both the diarrhea and abdominal pain associated with IBS-D.
VIBERZI is an oral medication that relieves the core symptoms of IBS-D, diarrhea and abdominal pain. Symptom relief was maintained throughout treatment in two pivotal clinical trials.
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.[iv]
VIBERZI (eluxadoline) is a twice daily, oral medication indicated for use in adults suffering from irritable bowel syndrome with diarrhea (IBS-D).
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