SAN FRANCISCO, Dec. 9, 2014 /PRNewswire/ -- Nektar
Therapeutics (NASDAQ:NKTR) reported partner AstraZeneca today
announced that MOVENTIG® (naloxegol) has been granted
Marketing Authorisation by the European Commission (EC) for the
treatment of opioid-induced constipation (OIC) in adult patients
who have had an inadequate response to laxative(s). MOVENTIG is the
first once-daily oral peripherally-acting mu-opioid receptor
antagonist (PAMORA) to be approved in the European Union (EU).
Opioids play an important role in chronic pain relief and 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.
Briggs Morrison, Executive Vice
President, Global Medicines Development & Chief Medical
Officer, AstraZeneca, said: "Constipation is one of the most common
side effects for those using opioid pain medication. We're very
pleased to have received marketing authorisation for MOVENTIG, as
it allows us to offer a new treatment option for the millions of
patients across Europe who suffer
from opioid-induced constipation and haven't responded to
laxatives."
The approval of MOVENTIG was based on data from the KODIAC
clinical programme, which was 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.
The EC marketing authorisation applies to all member states of
the EU, Iceland, Norway and Lichtenstein. Today's announcement
follows the approval on 16 September
2014 of MOVANTIKTM (naloxegol) tablets by the US
Food and Drug Administration, as the first once-daily PAMORA for
the treatment of OIC in adult patients with chronic non-cancer
pain.
About
MOVENTIG® (naloxegol)
MOVENTIG
is a peripherally-acting mu-opioid receptor antagonist (PAMORA)
specifically designed for the treatment of opioid-induced
constipation (OIC) in adult patients on prescription opioid pain
medicines. In Phase III clinical studies, MOVENTIG 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.
The KODIAC clinical programme was comprised of four studies:
KODIAC-4, -5, -7 and -8. KODIAC-4 and -5 were identically designed,
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 long-term safety
study.
MOVENTIG is part of the exclusive worldwide licence agreement
announced on 21 September 2009
between AstraZeneca and Nektar Therapeutics. MOVENTIG was developed
using Nektar's oral small molecule polymer conjugate
technology.
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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SOURCE Nektar Therapeutics