sNDA Submitted for Amitiza for Opioid-Induced Constipation

Sucampo and Takeda Pharmaceuticals announced the filing of a supplemental new drug application (sNDA) with the FDA seeking approval for a new indication for Amitiza (lubiprostone) for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.

The filing is based on results from three Phase 3, well-controlled studies of 12 weeks' duration in patients taking opioids chronically for non-cancer pain, as well as a long-term, open-label safety study, which provide additional support for use in this population.

Lubiprostone is a chloride channel activator currently indicated for the treatment of chronic idiopathic constipation (CIC) in adults and for irritable bowel syndrome with constipation (IBS-C) in women ≥18 years of age.

For more information call (877) 825-3327 or visit www.sucampo.com or www.tpna.com.