You are here

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.]

Recent Headlines

WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs