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news.Sucampo Pharmaceuticals and Takeda Pharmaceuticals USA have received FDA priority review status for Amitiza (lubiprostone) for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.
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Amitiza, a chloride channel activator, is indicated for the treatment of chronic idiopathic constipation (CIC) in adults and for irritable bowel syndrome with constipation in 18 year and older women by the FDA in the US.
Sucampo chairman, chief scientific officer, and chief executive officer Dr. Ryuji Ueno said opioid-induced constipation is one of the most common adverse reactions of opioid medications.
"The priority review of this sNDA application underscores that the management of OIC is an unmet need of patients with chronic pain and highlights the need for new therapies to address this condition," Dr. Ueno added.
With the issuance of priority review designation, Sucampo and Takeda anticipate the regulatory agency’s decision by January 2013.
Amitiza is approved for chronic constipation (apart from constipation caused by organic diseases) in Japan, for CIC in Switzerland and the UK.