AstraZeneca constipation drug gets EU nod
pharmafile | December 9, 2014 | News story | Sales and Marketing | AstraZeneca, KODIAC, NKTR-118, PAMORA, moventig, naloxegol
AstraZeneca’s opioid-induced constipation drug Moventig has been approved by the European Commission.
The first once-daily PAMORA tablet to be given the nod in Europe, Moventig (naloxegol) – or Movantik as it is known in the US – will be used to treat adult patients who have had an inadequate response to laxatives.
Data from AZ’s Phase III KODIAC trial showed Moventig blocked the binding of opioids to opioid receptors, in tissues such as the gastrointestinal (GI) tract.
“Constipation is one of the most common side effects for those using opioid pain medication, says Dr Briggs Morrison who is the executive VP and chief medical officer for medicines at AstraZeneca.
“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 condition affects twice as many women as men and is also more common in older adults and during pregnancy. Constipation is one of the most common GI problems, affecting about 42 million people in the US according to the National Institute of Diabetes and Digestive and Kidney Diseases.
This announcement follows the approval of the drug in the US which is expected to be made available for patients by the first half of next year.
The FDA green light back in September was based on data from four studies from the KODIAC clinical programme. At the time Morrison said: “We are pleased to provide doctors and their patients with a once-daily oral treatment supported by a robust clinical programme.”
Anti-constipation drug development
Initiating the start of AZ’s production of this recently approved drug was the deal the pharma company struck up with Nektar Therapeutics.
In an anti-constipation drug development contract worth more than $735 million in 2009, the agreement between the two firms commenced the production of a late stage investigational product for the treatment of opioid-induced constipation, NKTR-118 or naloxegol.
The early stage programme NKTR-119, which aimed to deliver pain relief products without constipation side effects was also developed through the agreed deal.
Tom Robinson
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