LONDON (Alliance News) - AstraZeneca PLC Tuesday said the US Food and Drug Administration has approved its MOVANTIK (naloxegol) tablets C-II for the treatment of opioid-induced constipation, in adult patients with chronic, non-cancer pain.
According to AstraZeneca, opioids play an important role in chronic pain relief and millions of patients are treated with them in the US each year. The company said 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 opioid-induced constipation.
"The FDA approval of MOVANTIK provides a new treatment option for adult patients with chronic non-cancer pain suffering from opioid-induced constipation, a common side effect of opioid therapy," said Briggs Morrison, executive vice president, global medicines development & chief medical officer for AstraZeneca. "We are pleased to provide physicians and their patients with a once-daily oral treatment supported by a robust clinical programme," Morrison added.
MOVANTIK is expected to be available to patients in the first half of 2015, AstraZeneca said. 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," the company said.
AstraZeneca submitted a petition for the descheduling of MOVANTIK to the US Drug Enforcement Administration 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.
AstraZeneca shares Tuesday closed down 0.7% at 4551.5 pence.
By Samuel Agini; samagini@alliancenews.com; @samuelagini
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