The U.S. Food and Drug Administration has announced last Thursday its approval of Synergy Pharmaceuticals’s oral treatment for chronic idiopathic constipation (CIC).
The one-a-day tablet, Trulance, is New York-based Synergy’s first to obtain regulatory clearance. It works in the upper gastrointestinal tract to stimulate intestinal fluid secretion and support regular bowel movement.
Treatment Option For Adults
“No one medication works for all patients suffering from chronic gastrointestinal disorders,” said Dr. Julie Beitz, Drug Evaluation III director at the agency’s Center for Drug Evaluation and Research, highlighting the need for new therapies to help doctors select the most appropriate one for their patients.
The FDA added, however, that the safety and effectiveness of Trulance are yet to be established in patients less than age 18.
CIC specifically afflicts 14 percent of the global population, and it is marked by difficult and infrequent bowel movements with a largely unknown cause.
The newly approved drug, whose chemical name is plecanatide, met the safety and efficacy goals of two late-phase studies in December on irritable bowel syndrome patients who have constipation (IBS-C). The two trials covered 1,775 adults and ran for 12 weeks.
Trulance, however, is not advisable for those ages 6 to 18, particularly in children less than 6 years old due to the danger of serious dehydration. Its most common side effect is diarrhea.
Trulance is expected to compete with Linzess of Ironwood Pharmaceuticals, another CIC drug approved in the United States last 2012. Sold by Allergan Plc in North America as well as in Europe, Linzess generated $464.7 million in global sales in nine months ending last Sept. 30.
Constipation In Focus
Recently, U.S. regulators also granted priority review to Swiss pharmaceutical Roche’s Tecentriq immunotherapy treatment for a kind of bladder cancer. Tecentriq (atezolizumab) was given approval in May 2016 as treatment for patients of urothelial carcinoma, the most common form of bladder cancer, and it was the first treatment given the green light for the disease in more than three decades.
About 42 million today suffer from constipation, the National Institutes of Health stated. Its short-term effects include abdominal pain, bloating, and small amounts of blood or whitish mucus found in the stool.
Chronic, long-term constipation leads to more harmful effects, with earlier research demonstrating an association between chronic constipation and cardiovascular disease. Constipation has also been linked to hemorrhoids and anal fissures.
One may become constipated upon intake of antacid drugs containing calcium or aluminum, dietary changes, onset of neurological disorders like Parkinson’s, and heavy intake of dairy products. It is also commonly caused by not getting enough water or fiber in one’s diet.
Fiber, for instance, promotes movement in the digestive tract and greater stool bulk, so one is encouraged to get plenty of it through consumption of vegetables and fruits. Good fiber sources include carrots, apples, and beans, as well as prunes and bran cereals for constipation patients.
A separate study early this month revealed that inflammatory bowel disorders such as Crohn’s disease and ulcerative colitis in children may be treated through diet regulation instead of complex medication with steroids and drugs that potentially carry long-term side effects.