Form(ulation) follows function

A clinical study of two formulations of marketed drug Linzess linaclotide supports Ironwood Pharmaceuticals Inc.’s hypothesis that pain in irritable bowel syndrome with constipation is not due to constipation alone, but also to hypersensitive nerves in the colon. The work could lead to new indications for linaclotide, and better management of abdominal pain for patients with and without constipation.

In December, Ironwood announced top-line data from a Phase IIb study showing that two formulations of linaclotide relieved pain better than placebo in patients with IBS-C. One formulation enhanced the analgesic activity of the molecule while preserving its activity on constipation. The other formulation was designed to reduce pain but have little or no activity on constipation, and the study showed this to be the case...