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.
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
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.
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.
KODIAC-4 and -5 were published in the New England Journal of
on 19 June 2014. Naloxegol is also
under regulatory review by the European Medicines Agency (EMA).
MOVANTIK™ (naloxegol) tablets C-II
(naloxegol) is the first FDA approved once-daily peripherally-acting mu-opioid
receptor antagonist (PAMORA) specifically designed for the treatment of
opioid-induced constipation (OIC) in adult patients with chronic non-cancer
pain. In the Phase III clinical studies, MOVANTIK was administered as a
once-daily tablet and was designed to block the binding of opioids to opioid
receptors in tissues such as the gastrointestinal (GI) tract.
part of the exclusive worldwide licence agreement announced on 21 September 2009 between AstraZeneca and Nektar
Therapeutics. MOVANTIK was developed using Nektar's oral small molecule polymer