TMCnet News
FDA Approves MOVANTIK™ (naloxegol) Tablets C-II for the Treatment of Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer PainWILMINGTON, Del. --(Business Wire)-- AstraZeneca (NYSE: AZN) today announced that the US Food and Drug Administration (FDA) approved MOVANTIK™ (naloxegol) Tablets C-II as the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC), in adult patients with chronic, non-cancer pain. Millions of patients are treated with opioids in the United States. Opioids play an important role in chronic pain relief by binding to mu-receptors in the central nervous system, but they also bind to mu-receptors in the gastrointestinal tract, which may result in OIC. "The FDA approval of MOVANTIK provides a new treatment option for adult patients with chronic non-cancer pain suffering from opioid-induced constipation, a common side effect of opioid therapy," said Dr. Briggs Morrison, Executive Vice President, Global Medicines Development & Chief Medical Officer, AstraZeneca. "We are pleased to provide physicians and their patients with a once-daily oral treatment option supported by a robust clinical program." The FDA approval of MOVANTIK was based on data from the KODIAC clinical program, which is comprised of four studies: KODIAC-4, -5, -7 and -8. KODIAC-4 and -5 were both placebo controlled, double-blind, 12 week studies assessing safety and efficacy, while KODIAC-7 was a 12 week safety extension to KODIAC-4, and KODIAC-8 was a 52 week long-term, open-label, safety study. MOVANTIK is expected to be available to patients in the first half of 2015. MOVANTIK is currently a schedule II controlled substance because it is structurally related to noroxymorphone. During the review of the NDA, the FDA evaluated the abuse potential of MOVANTIK and the approved labeling indicates that MOVANTIK has no risk of abuse or dependency. AstraZeneca submitted a petition for the descheduling of MOVANTIK to the US Drug Enforcement Administration (DEA) in March 2012 which was accepted for review and will be considered by the DEA as part of the process for addressing the descheduling request. Results from KODIAC-4 and -5 were published in the New England Journal of Medicine (NEJM) on June 19, 2014. Important Safety Information for MOVANTIK
Please see full US Prescribing Information NOTES TO EDITORS About MOVANTIK™ (naloxegol) tablets C-II MOVANTIK™ (naloxegol) tablets C-II is the first FDA approved once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) specifically designed for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. In the Phase III clinical studies, MOVANTIK was administered as a once-daily tablet and was designed to block the binding of opioids to opioid receptors, in tissues such as the gastrointestinal (GI) tract. MOVANTIK is part of the exclusive worldwide license agreement announced on September 21, 2009 between AstraZeneca and Nektar Therapeutics. MOVANTIK was developed using Nektar's oral small molecule polymer conjugate technology. About AstraZeneca AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information about AstraZeneca in the US or our AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363). 3026006 Last updated 9/14
|