The first patient has been enrolled in a phase III study of Amitiza® (lubiprostone) for treating opioid-induced bowel dysfunction (OBD), according to the drug’s manufacturers.
Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America said the programme consists of two 12-week double-blind studies, followed by a nine-month open-label safety extension study.
The double-blind studies are expected to test some 840 patients at up to 190 sites in the USA and Canada, and will evaluate the effects of lubiprostone as a treatment for constipation stemming from the use of painkillers such as morphine and codeine.
Lubiprostone is being reviewed by the FDA for irritable bowel syndrome with constipation.
Dr Egilius Spierings, associate clinical professor of neurology at Brigham and Women’s Hospital in Boston, USA, said: “Each year, millions of patients who suffer from chronic pain are treated with opiates.
“Many of these patients frequently develop severe constipation from these powerful analgesics.
“However, there are currently no approved prescription products available to treat this condition.
“This study is designed to determine whether lubiprostone can help many Americans who have constipation as a result of taking opioid-based drugs for chronic pain.”
Copyright © PA Business 2007