US FDA accepts AstraZeneca’s NDA for naloxegol
The US Food and Drug Administration has accepted the New Drug Application for naloxegol, an investigational peripherally-acting mu-opioid receptor antagonist (PAMORA) from Anglo-Swedish drug major AstraZeneca (LSE: ANZ), the company revealed this morning.
Naloxegol is part of the exclusive worldwide license agreement announced in 2009, between AstraZeneca and Nektar Therapeutics (Nasdaq: NKTR). Under the terms of the amended license agreement, AstraZeneca will make a $70 million milestone payment to Nektar within five business days of acceptance of the NDA by the FDA.
The drug has been studied in opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, the most common side effect caused by chronic administration of prescription opioid pain medicines. A Marketing Authorization Application for naloxegol was recently accepted by European Medicines Agency, which prompted a $25 million payment to Nektar (The Pharma Letter September 27).
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