Approximately 620 patients participated in the Phase III trial.
The year-long study tested the effectiveness of naldemedine in treating opioid-induced constipation (OIC) in patients with chronic non-cancer pain (CNCP). The participants were eligible for the trial if they had four or fewer spontaneous bowel movement (SBMs) in the two-week qualifying period. Patients also had to have three or less SMBs during any week during that time period.
"We've seen these good results in earlier three-month studies of naldemedine, but now we have evidence of similar positive outcomes in patients on the treatment for one year," Shionogi Inc. SVP Clinical Development Dr. Juan Camilo Arjona Ferreira said. "This is encouraging news for chronic non-cancer pain patients with OIC, who suffer with this condition and are seeking safe and effective treatment options."
Patients treated with opioids for pain frequently suffer from severe constipation. After opioid treatment begins, fewer bowel movements, straining to pass bowel movements and hard stools are the primary symptoms of OIC. Other symptoms include loss of appetite, bloating, cramping and vomiting.
The New Drug Application (NDA) for naldemedine has been accepted for review by the U.S. Food and Drug Administration (FDA). Shionogi also submitted an NDA in Japan on March 30.
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