Manufactured by Synergy Pharmaceuticals Inc., Trulance will compete directly with Lizness, produced by Alergan PLC and Ironwood Pharmaceuticals Inc., which already has a strong hold in the market.
The approval followed intensive review by the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. The safety and effectiveness of Trulance was evidenced by two 12-week placebo-controlled clinical trials that included 1,775 adult patients.
The participants in the trials were required to have been diagnosed with constipation at least six months prior to the beginning of the study and to have continuing symptoms in the three months leading up to its start. Patients who were randomly assigned Trulance during the study were more likely to experience improvement in their symptoms.
“No one medication works for all patients suffering from chronic gastrointestinal disorders,” Dr. Julie Beitz, director of the Office of Drug Evaluation II in the FDA Center for Drug Evaluation and Research, said in a statement. “With the availability of new therapies, patients and their doctors can select the most appropriate treatment for their condition.”
The National Institute of Health reports that 42 million people in the U.S. are affected by constipation each year. A diagnosis of chronic idiopathic constipation is reserved for those patients who experience persistent symptoms with no known structural or biochemical causation. Taken once daily orally, Trulance stimulates the secretion of intestinal fluid and supports healthy bowel function.