AstraZeneca’s naloxegol for opioid-induced constipation has been approved in the EU as Moventig, a few weeks after getting the go-ahead in the US.
Moventig is the first once-daily peripherally-acting mu-opioid receptor antagonist (PAMORA) to be approved in the EU, according to AZ, and has been approved to constipation in patients who do not respond to laxative therapy.
Constipation is a common side effect in patients taking opioid drugs to control chronic pain, and naloxegol acts by selectively blocking the effects of the drugs in the gastrointestinal tract whilst leaving them free to exert their pain-killing effects in the central nervous system.
Moventig – which is being sold as Movantik in the US – was approved on the back of AZ’s KODIAC clinical programme, which showed that the drug was superior to a placebo in restoring normal bowel movements in patients with opioid-induced constipation.
The launch of the product in the US was held up by deliberations at the US Drug Enforcement Administration (DEA), which recommended early last month that it should not be subject to any scheduling-related control as it had no risk of abuse. The verdict is subject to a 30-day comment period and a final verdict is expected imminently.
The FDA has also asked for a cardiovascular outcomes trial to be carried out post-registration, although there had been earlier suggestions that such a study should be a requirement for marketing approval.
Briggs Morrison, AZ’s chief medical officer, said the drug “offers a new treatment option for the millions of patients across Europe who suffer from opioid-induced constipation and haven’t responded to laxatives.”
The company has said previously it intends to launch naloxegol in both the US and Europe by the end of the first quarter of 2015 or early in the second quarter.
The EU approval is also a boost for Nektar Therapeutics, the company that invented and developed Moventig/Movantik and licensed the drug to AZ in 2009. Nektar stands to get $100m from AZ on the launch of the drug in the US and a further $40m upon launch in the EU, as well as up to $375m in sales milestones and double-digit royalties.
Nektar’s chief executive Howard Robin said last month that the launch of Movantik/Moventig will be “transformative” for the company, adding that he expects sales of the product to reach more than $1bn a year, given there are “millions of patients in the US and Europe that take opioids to manage their chronic pain.”
“We believe Movantik is not likely to face potential competition from other oral PAMORA therapies for at least two to three years,” he added.