The US Food and Drug Administration (FDA) has approved lubiprostone (Amitiza, Sucampo Pharmaceuticals Inc/Takeda Pharmaceuticals USA Inc), the first oral treatment for opioid-induced constipation in adults with chronic noncancer pain.
This was a Supplemental New Drug Application that received a priority review. This is the third indication for this drug, which is already approved in the United States for the treatment of chronic idiopathic constipation in adults, also at a dose of 24 μg twice daily, and irritable bowel syndrome with constipation in women 18 years of age and older, at a dose of 8 μg twice daily.
Approval was based on results from 12-week phase 3 studies in patients taking opioids, including morphine, oxycodone, and fentanyl, for chronic noncancer pain, and a long-term open-label safety study, a release from the companies notes. Two of the phase 3 studies met the overall efficacy endpoint, although a third study did not, they add.
The effectiveness of this drug in patients taking diphenylheptane opioids, such as methadone, hasn't been established, the release points out, and concomitant use of these opioids may interfere with its effectiveness.
Opioid-induced constipation is a common adverse effect of long-term opioid use because the binding of opioids to peripheral opioid receptors in the gastrointestinal (GI) tract results in absorption of electrolytes, such as chloride, with a subsequent reduction in small intestinal fluid. Activation of enteric opioid receptors also results in abnormal GI motility. Constipation occurs commonly in patients receiving opioids and can be severe enough to cause discontinuation of therapy.
Lubiprostone is a specific activator of CIC-2 chloride channels in the intestinal epithelium and bypasses the antisecretory action of opiates by activation of apical CIC-2 channels.
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