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Plecanatide was safe, effective for reducing pain in patients with IBS-C

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PHILADELPHIA — Plecanatide showed improvements in complete spontaneous bowel movements, abdominal pain and straining in a majority of patients with irritable bowel syndrome with constipation, according to a presenter at the ACG Annual Scientific Meeting. 

“Plecanatide was safe, well-tolerated and efficacious for the treatment of IBS-C patients,” Philip B. Miner, MD, of the Oklahoma Center for Clinical Research, said during his presentation. “It confirms the dose response pharmacology and predictable treatment response with efficacy and safety observed in the same dose range as in the CIC trials.”

In determining the safety and efficacy of plecanatide, 424 patients with irritable bowel syndrome with constipation (IBS-C) were randomly assigned to receive either a 0.3 mg (n=84), 1 mg (n=83), 3 mg (n=86) or 9 mg (n=85) oral tablets of plecanatide or placebo (n=85) once a day for 12 weeks.

The patients who received 1 mg, 3 mg and 9 mg of plecanatide showed improved rates of complete spontaneous bowel movements (CSBM) frequency on a weekly basis; increases of 2.12 for 1 mg, 2.74 for 3 mg and 2.44 for 9 mg, compared with placebo (P<.05 for each comparison).

The group of patients receiving 3 mg plecanatide reported the most improvement in FDA overall responder endpoint where abdominal pain improved by at least 30% and CSBM increased by at least one; overall intensity of abdominal pain from baseline; stool consistency; and straining. Patients in the 9 mg plecanatide group also showed improvement in the same areas as the 3 mg group.  

“Placebo and all of the doses of medication were significant in terms of changing the Bristol Stool Scale,” Miner said.

The most common adverse event experienced by patients in the plecanatide groups was diarrhea (9.4% of patients in the 1 mg group; 9.3% of patients in the 3 mg group; and 11.8% of patients in the 9 mg group).

For more information:

Miner PB. Abstract 14. Presented at: Annual ACG Scientific Meeting, Oct. 20-22, 2014; Philadelphia, PA.

Disclosure: Miner is a consultant for Synergy Pharmaceuticals, Inc.