Nektar Therapeutics and AstraZeneca announced that the FDA has accepted its New Drug Application (NDA) for naloxegol, in opioid-induced constipation (OIC) for adult patients with chronic non-cancer pain. Naloxegol is an investigational peripherally-acting mu-opioid receptor antagonist (PAMORA).
The NDA filing was based on data from the Phase 3 KODIAC program, consisting of four clinical trials designed to evaluate the safety and efficacy of naloxegol for the treatment of OIC. Two pivotal Phase 3 studies, KODIAC-04 (n=652) and KODIAC-05 (n=700), both 12-week, multicenter, randomized, double blind, placebo-controlled pivotal trials evaluated 12.5mg and 25mg 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 may be the first once-daily oral peripherally acting mu-opioid receptor antagonist for patients with OIC. Naloxegol was developed using Nektar’s oral small molecule polymer conjugate technology.