Trulance received FDA approval for the treatment of chronic idiopathic constipation, according to press releases from the manufacturer and the FDA.
“The impact of chronic constipation on the lives of affected patients is often underestimated,” William D. Chey, MD, co-director of the Michigan Bowel Control Program at the University of Michigan and Healio Gastroenterology Peer Perspective Board member, said in a press release. “Trulance presents an exciting new treatment option for patients with chronic constipation. Its efficacy and safety profile, plus its negligible systemic absorption, are attractive attributes that make it a welcome addition to our treatment options.”
The FDA approved Trulance (plecanatide, Synergy Pharmaceuticals) at a 3-mg dose, taken orally once a day with or without food. The drug works in the upper GI tract to mimic uroguanylin and improve regular bowel function.
William D. Chey
Approval came after two randomized, double blind, placebo-controlled clinical trials in which efficacy was studied in more than 2,600 patients and safety in more than 2,700. Patients were diagnosed with chronic idiopathic constipation (CIC) due to producing less than three spontaneous bowel movements (SBM) per week in the previous 3 months.
The efficacy responder rate — defined as at least three complete SBM in a given week and at least one CSBM over baseline in the same week for at least 9 weeks — was greater in both studies compared with placebo (21% vs. 10% and 21% vs. 13%; both P < .005). Those treated with plecanatide showed improvement in stool frequency, stool consistency and straining.
The FDA and manufacturer noted diarrhea as the most common adverse reaction (5% vs. 1% in placebo). Due to the risk for dehydration and lack of safety and efficacy data, the FDA said plecanatide should not be used in pediatric patients aged younger than 6 years and avoided from age 6 to age 18.
“No one medication works for all patients suffering from chronic gastrointestinal disorders,” Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in the FDA press release. “With the availability of new therapies, patients and their doctors can select the most appropriate treatment for their condition.”
Synergy Pharmaceuticals said the medication will be available for CIC patients in the U.S. this quarter. It is also being studied in IBS-C, according to the company. – by Katrina Altersitz
Disclosures: Beitz is an employee of the FDA. Chey reports he is a consultant for Albreio, Allergan, Ardelyx, IM Health, Ironwood, Nestle, Prometheus, QOL Medical, Salix, Syn Biologic and Takeda, and has received grant or research support from Ironwood, Nestle, Perrigo and Prometheus.