Oral Treatment for Opioid-Induced Constipation Approved

by U.S. Medicine

July 5, 2013

DEERFIELD, IL – Lubiprostone, marketed as Amitiza by Sucampo Pharmaceuticals Inc. and its partner Takeda Pharmaceuticals USA Inc., has been approved by the Food and Drug Administration (FDA) as the first oral treatment for opioid-induced constipation in adults with chronic noncancer pain.

The drug is a specific activator of ClC-2 chloride channels in the intestinal epithelium, and, through activation of apical ClC-2 channels in the intestinal epithelium, bypasses the antisecretory action of opiates.The new approval came after a Supplemental New Drug Application that received a priority review. The drug already is approved in the United States for the treatment of chronic idiopathic constipation in adults, also at a dose of 24 μg twice daily, and irritable bowel syndrome with constipation in women 18 years of age and older at a dose of 8 μg twice daily.

FDA approval was based on results from 12-week, Phase 3 studies in patients taking opioids, including morphine, oxycodone and fentanyl for chronic noncancer pain and a long-term open-label safety study. Two of the Phase 3 studies met the overall efficacy endpoint, although a third study did not, according to a Sucampo press release.

The manufacturer points out that the effectiveness of the drug in patients taking diphenylheptane opioids, such as methadone, hasn’t been established and that concomitant use of these opioids might interfere with its effectiveness.

Opioid-induced constipation is a common adverse effect of long-term opioid use because the binding of opioids to peripheral opioid receptors in the gastrointestinal (GI) tract results in absorption of electrolytes, such as chloride, with a subsequent reduction in small intestinal fluid. Activation of enteric opioid receptors also results in abnormal GI motility. 

Related Articles

New Agents Extend Options for Increased Survival in Metastatic Prostate Cancer

Accounting for nearly a third of all cancer diagnoses, prostate cancer is the most frequently diagnosed cancer in the VHA, where past research has suggested that the malignancy is caught earlier than in other healthcare systems.

Personalized Medicine Brightens Outlook for Most Common Kidney Cancer

In the past five years, 10 new system therapies have been approved for renal cell carcinoma (RCC), the most common type of kidney cancer.

U.S. Medicine Recommends

More From pharmacy


EMR Alert Helps Reduce Opioid/Benzodiazepine Co-Prescribing Risk at VAMCs

Since the launch of the Opioid Safety Initiative in 2012, the VA has implemented a number of steps designed to reduce the use of opioids and the risk of addiction and overdose among veterans.


VA Takes the Lead to Prevent Spread of Multi Drug-Resistant Organisms

The VA is leveraging its position as the country’s largest integrated healthcare system to slow the development and spread of multidrug-resistant organisms (MDRO).


Military E-Prescriptions Exceed 50% Goal Set Three Years Ago

FALLS CHURCH, VA — As of January 2018, 54% of prescriptions filled by MTFs were submitted electronically, exceeding the initial goal of 50% set when the e-prescribing program first rolled out three years ago.


San Diego Revises Alert System in Wake of Administration of Compromised Flu Vaccine

In the fall, failure of a pharmacy refrigerator and its monitoring system resulted in 1,540 veterans and staff receiving potentially ineffective shots.


Shortage of Supplies Might Have Delayed Medical Procedures at VAMCs

In response to complaints that clinicians at VAMCs lack adequate medical and surgical products to care for veterans, VA conceded it needs to make its product formulary more robust.

Facebook Comment

Subscribe to U.S. Medicine Print Magazine

U.S. Medicine is mailed free each month to physicians, pharmacists, nurse practitioners, physician assistants and administrators working for Veterans Affairs, Department of Defense and U.S. Public Health Service.

Subscribe Now

Receive Our Email Newsletter

Stay informed about federal medical news, clinical updates and reports on government topics for the federal healthcare professional.

Sign Up