FDA approves Movantik for treatment of Opioid-Induced Constipation in patients with Chronic Non Cancer Pain. - AstraZeneca

AstraZeneca has announced that the 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. Opioids play an important role in chronic pain relief and millions of patients are treated with them in the United States each year. They work by binding to mu-receptors in the central nervous system, but they also bind to mu-receptors in the gastrointestinal tract, which can result in patients suffering from OIC.

The FDA approval of Movantik was based on data from the KODIAC clinical programme, 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 open label, long-term safety study.

Movantik is expected to be available to patients in the first half of 2015.