13th Jun 2014 06:17
LONDON (Alliance News) - AstraZeneca PLC said late Thursday the US Food and Drug Administration's Analgesic Drug Products Advisory Committee has recommended the FDA not require cardiovascular outcomes trials for a class of drugs including AstraZeneca's movantix treatment.
Movantix is a mu-opioid receptor antagonist for the treatment of opioid-induced constipation in patients with chronic non-cancer pain.
Opioids assist with chronic pain relief by binding mu-receptors in the brain, but also bind nu-receptors in the bowel, which means patients taking opioids for chronic pain can develop opioid-induced constipation.
A majority of the committee voted in favour of not requiring cardiovascular outcomes trials for this class of drugs, suggesting instead post-approval data collection on cardiovascular safety.
The FDA is not bound by the committee's recommendation, but will take its advice in consideration in reviewing approvals for investigation medicines.
"We look forward to the outcome of the FDA?s review of the New Drug Application for movantix and the potential to provide patients with chronic non-cancer pain affected by opioid-induced constipation with an additional treatment option,? said Executive Vice President of Global Medicines Development and Chief Medical Officer Briggs Morrison in a statement.
Movantix is also under review with health agencies in the EU and Canada.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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