Moventig (naloxegol) now available for patients in England and Wales with opioid-induced constipation
AstraZeneca has announced that MOVENTIG® (naloxegol) has been made available for adult patients with opioid-induced constipation (OIC) in England and Wales through the National Health Service (NHS).MOVENTIG® is the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) and is recommended by the National Institute for Health and Care Excellence (NICE) as a cost-effective treatment for adult patients with OIC who have had an inadequate response to laxatives.1 NICE also states that MOVENTIG® would be equally effective in people with cancer pain who have OIC.2 However, NICE recommends doctors consult the summary of product characteristics before prescribing as there is limited clinical experience of MOVENTIG® in this patient population1 and MOVENTIG® is contraindicated in adult patients with underlying cancer who are at heightened risk of gastro-intestinal (GI) perforation.1 The Committee however, is persuaded that MOVENTIG® is equally effective in this patient population.
Millions of patients are prescribed with opioid treatments each year and OIC is the most commonly reported side effect.3 The incidence of OIC in patients with chronic pain varies and has been suggested to be as high as 81%.4 Even though opioids play an important role in pain management5 by binding to mu-receptors in the central nervous system (CNS) providing analgesic effects, they can also bind to mu-receptors in the bowel, which can result in patients suffering from OIC.5,6,7
Dr Andrew Davies, Clinical Director Supportive & Palliative Care at Royal Surrey County Hospital said “Opioid induced constipation is a common problem, which can have a significant impact on quality of life. Current management options are somewhat limited, and so the release of a new targeted treatment is very welcome”.
OIC is also common in cancer patients who require regular opioid administration for pain and rates of the condition in patients receiving opioids and cancer treatment can range from 69-90%.8,9 Of those taking opioid analgesics, around 87% of patients require laxatives.10 Unlike conventional laxatives,6 MOVENTIG® binds to mu-receptors in the bowel, targeting the underlying cause of OIC5 at its source in the bowel without impacting opioid-mediated analgesic effects on the CNS.1
The licensing of MOVENTIG® was largely based on data from the KODIAC clinical programme, which was comprised of four studies: KODIAC-4,1 -5, 1 -71 and -8,1 enrolling more than 2000 adult patients. KODIAC-41 and -51 were identically designed, placebo controlled, double-blind, 12 week studies assessing safety and efficacy, while KODIAC-71 was a 12 week safety extension to KODIAC-4,1 and KODIAC-81 was a 52 week open label, long-term safety study. These pivotal trials demonstrated a consistent efficacy and safety profile of MOVENTIG®.
“Opioid-induced constipation is a common and often under-reported problem among patients on opioids. AstraZeneca are delighted to be able to offer MOVENTIG®, an innovative treatment option for adult patients with opioid-induced constipation, who have had an inadequate response to laxatives,” said Lisa Anson, President of AstraZeneca UK & Ireland. “MOVENTIG®will now be available for prescription through the NHS in England and Wales. This highlights the clinical benefit and cost-effectiveness provided by MOVENTIG®.
“On 8 December 2014, MOVENTIG® was granted Marketing Authorisation by the European Commission (EC). The EC marketing authorisation applies to all member states of the EU, Iceland, Norway and Liechtenstein. MOVENTIG® has also been made available to adult patients in Sweden, Denmark, Norway and Finland.