Nektar Therapeutics (NASDAQ: NKTR) reported today that partner AstraZeneca today announced that the US Food and Drug Administration (FDA) approved MOVANTIK™ (naloxegol) tablets as the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC), in adult patients with chronic, non-cancer pain.
Opioids play an important role in chronic pain relief and millions of patients are treated with them in the United States each year. They work by binding to mu-receptors in the central nervous system, but they also bind to mu-receptors in the gastrointestinal tract, which can result in patients suffering from OIC.
"As the first once-daily oral PAMORA approved in the U.S., MOVANTIK provides a new treatment option for a common and potentially debilitating side effect experienced by adult patients treated with opioids," said Howard W. Robin, President and CEO of Nektar Therapeutics. "Further, the approval of MOVANTIK represents a significant milestone in Nektar's evolution as it is the first oral small molecule medicine to be created with our proprietary polymer chemistry platform."
The FDA approval of MOVANTIK was based on data from the KODIAC clinical programme, which is comprised of four studies: KODIAC-4, -5, -7 and -8. KODIAC-4 and -5 were both placebo controlled, double-blind, 12 week studies assessing safety and efficacy, while KODIAC-7 was a 12 week safety extension to KODIAC-4, and KODIAC-8 was a 52 week open label, long-term safety study.
In line with the recommendation from the FDA Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) that took place in June 2014, AstraZeneca has agreed to conduct a post-marketing, observational epidemiologic cardiovascular safety study for MOVANTIK.
MOVANTIK is expected to be available to patients in the first half of 2015. MOVANTIK is currently a schedule II controlled substance because it is structurally related to noroxymorphone. During the review of the New Drug Application, the FDA evaluated the abuse potential of MOVANTIK and the approved labelling indicates that MOVANTIK has no risk of abuse or dependency. AstraZeneca submitted a petition for the descheduling of MOVANTIK to the US Drug Enforcement Administration (DEA) in March 2012, which was accepted for review and will be considered by the DEA as part of the process for addressing the descheduling request.
Results from KODIAC-4 and -5 were published in the New England Journal of Medicine on 19 June 2014. Naloxegol is also under regulatory review by the European Medicines Agency (EMA).