The NDA filing was based on comprehensive data from the core Phase III KODIAC programme, which is comprised of four clinical trials designed to investigate the safety and efficacy of naloxegol for the treatment of OIC. Two pivotal Phase III studies, KODIAC-04 (n=652) and KODIAC-05 (n=700), both 12-week, multicentre, randomized, double blind, placebo-controlled pivotal trials evaluated 12.5 mg and 25 mg doses of naloxegol, administered 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.
Naloxegol has the potential to be the first once-daily oral PAMORA for patients with OIC in
Naloxegol is part of the exclusive worldwide license agreement announced on
About Naloxegol
Naloxegol is an investigational peripherally-acting mu-opioid receptor antagonist (PAMORA), which has been specifically designed for the treatment of opioid-induced constipation (OIC), a condition caused by prescription opioid pain medicines. Naloxegol is a once-daily tablet designed to block the binding of opioids to the opioid receptors in the gastrointestinal (GI) tract without impacting the opioid receptors in the brain.
Naloxegol is part of the exclusive worldwide license agreement announced on
About Opioid-Induced Constipation
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 (OIC) is a result of increased fluid absorption and lower GI motility due to opioid receptor binding in the GI tract.
Globally, approximately 40—50% (28-35 million) of patients taking opioids for long-term pain develop OIC. About 40—50% (11-18 million) of those OIC sufferers achieve the desired treatment outcomes with current options that include over-the-counter and prescription laxatives.
About Nektar
Nektar's technology has enabled eight approved products in the U.S. or
Nektar is headquartered in
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation 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 please visit: www.astrazeneca.com
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