NAPSR News: AstraZeneca and Nektar Therapeutics Receive FDA Approval for MOVANTIK™

WASHINGTON - Sept. 16, 2014 - PRLog -- AstraZeneca  and  Nektar Therapeutics have announced FDA approval of MOVANTIK™ (naloxegol) tablets C-II to treat opioid-induced constipation in adult patients with chronic, non-cancer pain. Opioids relieve chronic pain and in this case, function by binding mu-receptors in the gastrointestinal tract thus reducing the gastrointestinal tract’s motility, resulting in difficult bowel movements.  MOVANTIK™  is a peripherally acting opioid receptor antagonist and is intended to decrease the constipating effects of opioids

“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 supported by a robust clinical programme.”

The approval from the FDA comes from the KODIAC clinical programme encompassing four studies: KODIAC-4, -5, -7 and -8. Safety and efficacy of MOVANTIK was assessed in the KODIAC-4 and -5 studies which were were both placebo controlled, double-blind, 12 week studies.

MOVANTIK is part of the exclusive worldwide licence agreement between AstraZeneca and Nektar Therapeutics. The therapy was developed utilizing Nektar's oral small molecule polymer conjugate technology. The official launch of MOVANTIK™ is expected to happen in the first half of 2015.

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