FDA approves first oral agent for OIC in adults with chronic noncancer pain

FDA has approved a supplemental new drug application (sNDA) for lubiprostone (Amitiza, Sucampo Pharmaceuticals and Takeda Pharmaceuticals) 24 μg twice daily as the first oral medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, noncancer pain. 

The effectiveness of lubiprostone in the treatment of OIC in patients taking diphenylheptane opioids (eg, methadone) has not been established.

Opioid-based medicines are widely used in the management of chronic pain. OIC is a common adverse effect of chronic opioid use. Binding of opioids to peripheral opioid receptors in the gastrointestinal (GI) tract results in absorption of electrolytes, such as chloride, and subsequent reduction in small intestinal fluid. In addition, activation of enteric opioid receptors results in abnormal GI motility. Together, these processes result in OIC, which is characterized by infrequent and incomplete evacuation of stool, hard stool consistency, and straining associated with bowel movements.

“The FDA approval of Sucampo’s supplemental new drug application for Amitza reaffirms the Agency’s mission to ensure that new indications that are both credible and considered to be safe are made available to the general public,” said Formulary advisor Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, Webster, Texas. “The ability to allow for the release of effective and safe agents to the public is a goal that will continue to be a primary focus of FDA, and this is once again represented by the approval of this new drug application.”

This is the third indication for lubiprostone, which is also approved in the United States for the treatment of chronic idiopathic constipation (CIC) in adults (24 μg twice daily) and irritable bowel syndrome with constipation (IBS-C) in adult women (8 μg twice daily). There are more than 200 million prescriptions for opioid use in the United States annually, and a substantial number of these prescriptions are for noncancer chronic pain. Scientific literature indicates that approximately 40% to 80% of patients taking opioids chronically for noncancer pain report constipation.

This approval is based on results from phase 3, well-controlled studies of 12 weeks’ duration in patients taking opioids chronically for noncancer pain, as well as a long-term, open-label safety study, which provides additional support for use in this population. Two of the phase 3 studies met their overall efficacy end point, and a third phase 3 study did not.

“As a locally acting ClC-2 channel activator, Amitiza enhances chloride secretion together with intestinal fluid, which is important in its role in treating OIC,” said Ryuji Ueno, MD, PhD, PhD, chairman, chief scientific officer, and CEO, Sucampo, in a press statement.