FDA OKs Plecanatide for IBS with Constipation – APhA submits compounding comments to FDA. – (866) 348-2889
Officials with the FDA have approved plecanatide (Trulance, Synergy) for the once-daily treatment of irritable bowel syndrome with constipation (IBS-C) in adults, according to a Synergy press release. It is the second approved indication for the treatment.
Plecanatide was initially approved for the treatment of adults with chronic idiopathic constipation (CIC) and is the only prescription medication available for adults with CIC, and now IBS-C, that be taken once-daily with or without food.
The approval is based on the phase 3 IBS-C program, which included 2, 12-week trials evaluating the efficacy and safety of plecanatide in adult patients with IBS-C. More than 2100 patients received a once-daily tablet (3 mg or 6 mg doses) or a placebo. A 2-week, post treatment follow-up period was included in both trials.
In both trials, patients who received plecanatide experienced significantly reduced abdominal pain and improvement in stool frequency, stool consistency, and straining with bowel movements during the 12-week treatment period as compared to placebo.