The FDA has expanded the indication for oral lubiprostone (Amitiza) to include opioid-induced constipation in chronic, non-cancer pain patients, according to a statement from the drug’s manufacturers.
Lubiprostone is the first oral medication approved for the treatment of opioid-induced constipation in adult patients with chronic, non-cancer pain.
This is the third indication for the drug, which is also approved in the U.S. to treat chronic idiopathic constipation in adults and irritable bowel syndrome with constipation in adult women.
In the United States, more than 200 million prescriptions are filled for opioid use annually, and approximately 40% to 80% patients taking opioids chronically for non-cancer pain report constipation.
The supplemental new drug application for lubiprostone received priority FDA review. Approval was based on results from three phase III, placebo-controlled trials of patients receiving opioids including morphine, oxycodone, and fentanyl for noncancer pain. Two of the Phase III studies met their overall efficacy endpoint.
Lubiprostone is contraindicated in patients with known or suspected GI obstruction and in those with severe diarrhea. The drug’s efficacy in patients taking diphenylheptane opioids, such as methadone, has not been established.
Adverse events include nausea, diarrhea, headache, abdominal pain, abdominal distension and flatulence, as well as dyspnea within an hour of the first dose.
The safety of lubiprostone in pregnant patients has not been evaluated, and data from animal studies suggest it may cause fetal harm.
The drug is manufactured by Sucampo Pharmaceuticals and Takeda Pharmaceuticals U.S.A.