BETHESDA, Md. (AP) – Sucampo Pharmaceuticals Inc. said its bowel drug lubiprostone met its goal in a late-stage clinical trial, and it will file for marketing approval of the drug later this year.
Sucampo is studying lubiprostone as a treatment for bowel dysfunction caused by the use of opioid drugs like morphine and codeine. It said patients who took lubiprostone in the trial had greater improvement in bowel frequency rates and other symptoms through the 36-week trial. Opioid bowel dysfunction includes ailments like constipation and infrequent or difficult bowel movements. Many patients who take opioid drugs are affected.
The trial included 439 patients with chronic pain not caused by cancer. Sucampo said the most common side effects included diarrhea, nausea, upper respiratory infection, and back pain. The company plans to present more results from the trial at a future medical conference.
Sucampo also said it plans to ask the Food and Drug Administration to approve lubiprostone by mid-year. It will request a six-month priority review instead of the standard 10-month review.
Date: April 5, 2012
Source: Associated Press
Filed Under: Drug Discovery