Actavis Announces FDA Acceptance for Filing of NDA for Eluxadoline

DUBLIN, Sept. 2, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Actavis' New Drug Application (NDA) for eluxadoline, an investigational drug for the treatment of diarrhea and abdominal pain in men and women with diarrhea predominant Irritable Bowel Syndrome (IBS-D).  Actavis' NDA for eluxadoline has been granted priority review status by the FDA.

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"The NDA filing of eluxadoline marks an important step forward for this potential first-in-class treatment, which demonstrates our commitment to helping patients suffering from this debilitating condition," said Paul Covington, MD, Senior Vice President, Clinical Operations & Development at Furiex Pharmaceuticals, a subsidiary of Actavis.  "We are pleased that the FDA has granted eluxadoline a priority review, setting the stage for us to bring this potential  new treatment option to patients promptly." 

The NDA submission for eluxadoline is based on the results of two Phase III clinical studies that met their primary endpoints. The 12- week efficacy portion of the studies demonstrated significant superiority over placebo in the composite endpoint of the simultaneous improvement in both pain and diarrhea at both 75mg and 100mg doses.

Eluxadoline was well-tolerated and the adverse events (reported in greater than 5% of eluxadoline-treated patients and at an incidence greater than placebo) consisted of constipation (7.4% (75 mg) and 8.6% (100 mg) vs 2.5% placebo),  nausea (8.1% (75mg) and 7.5% (100mg) vs 5.1% placebo) and abdominal pain (4.1% (75mg) and 5.0% (100mg) vs 2.7% placebo).  The studies consisted of approximately 2,500 patients. 

Pursuant to pre-NDA discussions with FDA, Actavis is planning to submit an amendment to the NDA with additional data from a study that was ongoing at the time of submission. As a result, it is expected that this will extend the Prescription Drug User Fee Act (PDUFA) date by three months.  The Company expects the PDUFA date to be in Q2 2015.

"There continues to be an unmet need for treatments to manage the chronic symptoms experienced by patients with IBS-D. If approved, eluxadoline could be a promising option for patients who continue to suffer from these symptoms," said Anthony Lembo, MD, Attending Physician, Beth Israel Deaconess Medical Center and Associate Professor of Medicine, Harvard Medical School.

About Eluxadoline

Eluxadoline is a novel, orally active investigational compound being developed for the treatment of diarrhea and abdominal pain in men and women with diarrhea predominant irritable bowel syndrome (IBS-D).  Eluxadoline is a combined mu opioid receptor agonist and delta opioid receptor antagonist which acts locally in the gastrointestinal tract and has low systemic absorption and bioavailability.  The dual opioid activity is designed to treat the symptoms of IBS-D while reducing the incidence of constipation that can occur with unopposed mu opioid receptor agonists.

About IBS-D

IBS-D is a functional bowel disorder characterized by chronic abdominal pain and frequent diarrhea, which affects approximately 15 million patients in the U.S.  Although the exact cause of IBS-D is not known, symptoms are thought to result from a disturbance in the way the gastrointestinal track and nervous system interact.

IBS-D can be debilitating and there are limited therapeutic options for managing the chronic symptoms. IBS-D is associated with economic burden in direct medical costs and indirect social costs such as absenteeism and lost productivity, along with decreased quality of life.

About Actavis

Actavis plc (NYSE:ACT), headquartered in Dublin, Ireland, is a unique specialty pharmaceutical company focused on developing, manufacturing and commercializing high quality affordable generic and innovative branded pharmaceutical products for patients around the world.

Actavis markets a broad portfolio of branded and generic pharmaceuticals and develops innovative medicines for patients suffering from diseases principally in the central nervous system, gastroenterology, women's health, urology, cardiovascular, respiratory and anti-infective therapeutic categories. The Company is an industry leader in product research and development, with one of the broadest brand development pipelines in the pharmaceutical industry, and a leading position in the submission of generic product applications. Actavis has commercial operations in more than 60 countries and operates more than 30 manufacturing and distribution facilities around the world.

For more information, visit Actavis' website at www.actavis.com.

Actavis Cautionary Statement Regarding Forward-Looking Statements

Statements contained in this communication that refer to Actavis' estimated or anticipated future results, including estimated synergies, or other non-historical facts are forward-looking statements that reflect Actavis' current perspective of existing trends and information as of the date of this communication. Actual results may differ materially from Actavis' current expectations depending upon a number of factors affecting Actavis' business. These factors include, among others, the timing and success of product launches; the difficulty of predicting the timing or outcome of product development efforts and regulatory agency approvals or actions, if any; market acceptance of and continued demand for Actavis' products; difficulties or delays in manufacturing; and such other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis plc's Annual Report on Form 10-K for the year ended December 31, 2013, Quarterly Report on Form 10-Q for the quarter ended June 30, 2014 and from time to time in Actavis' other investor communications. Except as expressly required by law, Actavis disclaims any intent or obligation to update or revise these forward-looking statements.

SOURCE Actavis plc