FDA Agrees to Review Naloxegol for Use in Opioid-Induced Constipation
11 to 18 Million Patients Affected (November 19)
The FDA has accepted a New Drug Application (NDA) for naloxegol (Nektar Therapeutics/AstraZeneca), an investigational peripherally acting mu-opioid receptor antagonist. Naloxegol has been studied in opioid-induced constipation in adults with chronic non-cancer pain, the most common side effect caused by chronic administration of prescription opioid pain medications.
The NDA filing was based on comprehensive data from the core phase III KODIAC program, which is comprised of four clinical trials designed to investigate the safety and efficacy of naloxegol for the treatment of opioid-induced constipation. Two pivotal phase III studies, KODIAC-04 (n=652) and KODIAC-05 (n=700), both 12-week, multicenter, randomized, double-blind, placebo-controlled pivotal trials, evaluated naloxegol 12.5 mg and 25 mg once daily. KODIAC-07, a 12-week safety extension of KODIAC-04, and KODIAC-08 (n= 534), was an open-label controlled, randomized, 52-week, long-term safety trial.
Opioids bind to specific proteins called opioid receptors. When the opioids bind to certain opioid receptors in the gastrointestinal (GI) tract, constipation may occur. Opioid-induced constipation is a result of increased fluid absorption and lower GI motility resulting from opioid receptor binding in the GI tract.
Globally, approximately 40% to 50% of patients taking opioids for long-term pain (from 28 to 35 million) develop opioid-induced constipation. Only about 40% to 50% of patients with the condition (from 11 to 18 million) achieve the desired treatment outcomes with current options, which include over-the-counter and prescription laxatives.[Source: Nektar Therapeutics; November 19, 2013.]