New Drug Application for Amitiza Approved

Amitiza new drug application approved by FDA to treat constipation from opioids

/ Author:  / Reviewed by: Joseph V. Madia, MD

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals USA, Inc. announced today that the FDA has approved Sucampo’s supplemental new drug application (sNDA) for AMITIZA® (lubiprostone) (24 mcg twice daily) as the first and only oral medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain.

The effectiveness of AMITIZA in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (eg, methadone) has not been established.

This is the third indication for AMITIZA, which is also approved in the US for the treatment of chronic idiopathic constipation (CIC) in adults (24 mcg twice daily) and irritable bowel syndrome with constipation (IBS-C) in adult women (8 mcg twice daily).

There are more than 200 million prescriptions for opioid use in the US annually, and a substantial number of these prescriptions are for non-cancer chronic pain. Scientific literature indicates that approximately 40-80% of patients taking opioids chronically for non-cancer pain report constipation.

“This approval from the FDA, which received priority review status, provides the first and only oral treatment option for opioid-induced constipation in adult patients with chronic, non-cancer pain.

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, Chairman, Chief Scientific Officer, and Chief Executive Officer, Sucampo.

“With this third indication for AMITIZA, we are pleased to be able to provide physicians an important new option to help treat the unmet needs of their patients.”

Opioid-based medicines are widely used in the management of chronic pain, with OIC being a common adverse effect of chronic opioid use. Some patients may discontinue opioid therapy and thereby endure pain rather than suffer from the constipation the opioids cause.

“We are pleased with the FDA approval of this new indication for AMITIZA,” said Charlie Baum, Vice President, US Medical Affairs, Takeda. “It is critical that we continue to identify and respond to the needs of physicians and their patients with OIC.”

AMITIZA is a specific activator of ClC-2 chloride channels in the intestinal epithelium. AMITIZA, via activation of apical ClC-2 channels in the intestinal epithelium, bypasses the antisecretory action of opiates.

This approval is based on results from Phase 3, well-controlled studies of 12 weeks’ duration in patients taking opioids (among them morphine, oxycodone, and fentanyl) chronically for non-cancer 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 endpoint, while a third Phase 3 study did not.

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Review Date: 
April 23, 2013