Medication Monitor

Generic Name (Trade Name—Company)
January 26, 2018


(Trulance—Synergy Pharmaceuticals)
FDA approves plecanatide for once-daily treatment of IBS-C

FDA has approved plecanatide 3 mg tablets for once-daily treatment of irritable bowel syndrome with constipation (IBS-C) in adults. Plecanatide was previously approved for the treatment of adults with chronic idiopathic constipation (CIC).

Plecanatide is the only prescription medication for adults with CIC and now IBS-C that can be taken once daily, with or without food, at any time of the day. It is packaged in 30-day calendar blister pack.

Plecanatide demonstrated efficacy and safety in the treatment of more than 4,700 patients across both CIC and IBS-C clinical trials. Postmarketing data showed a diarrhea rate of less than 0.5% and no reports of severe diarrhea requiring hospitalization since the launch of the plecanatide CIC indication.

With the exception of a single amino acid substitution for greater binding affinity, plecanatide is structurally identical to human uroguanylin and is the only treatment thought to replicate the pH-sensitive activity of uroguanylin.