First brand alternative for opioid-induced constipation medication Amitiza® – lubiprostone – now on the market
The first brand alternative of Amitiza® – lubiprostone 8 mcg and 24 mcg capsules – is now available. Endo International plc announced that lubiprostone will be marketed under one of its operating companies, Par Pharmaceutical, Inc., on January 4, 2021.
Amitiza is approved by the U.S. Food and Drug Administration for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain and for chronic idiopathic (meaning the cause is unknown) constipation. The standard oral dose for these conditions is 24 mcg two times per day. Amitiza is also approved for the treatment of irritable bowel syndrome with constipation (IBS-C) in women 18 years of age and older. The standard oral dose for IBS-C is 8 mcg two times per day.
Impact on workers’ compensation and auto no-fault
Amitiza (lubiprostone) is classified as a miscellaneous gastrointestinal agent, rather than a laxative. Therefore, it is considered second-line therapy and not recommended until after non-pharmacologic therapies have been established and first-line medications have failed to alleviate OIC symptoms. According to treatment guidelines, non-pharmacologic treatment should begin at the onset of symptoms, after ruling out other causes, and include an increase in dietary fiber intake, adequate hydration, regular exercise and establishing a toileting routine.
First-line medications recommended to supplement non-pharmacologic therapy include:
- Osmotic laxatives (e.g., polyethylene glycol or lactulose)
- Stimulant laxatives (e.g., bisacodyl or senna)
- Stool softeners (e.g., docusate) can be helpful when combined with one of the laxatives above
Given the FDA-labeled indications and treatment guideline recommendations, our Pharmacy and Therapeutics Committee determined in 2019 that Amitiza 24 mcg requires prior authorization and Amitiza 8 mcg is excluded on our global workers’ compensation, auto and standard injury-based formularies. With that said, lubiprostone will follow this same plan design.
For more information about Amitiza, please click here.
If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.
- Endo International plc. Press Releases. Endo Launches Authorized Generic Version of Amitiza® (lubiprostone) Capsules in the United States. January 4, 2021. Available at https://investor.endo.com/news-releases/news-release-details/endo-launches-authorized-generic-version-amitizar-lubiprostone.
- Crockett SD, et al. American Gastroenterological Association Institute Guideline on the Medical Management of Opioid-Induced Constipation. Gastroenterology. 2019;156(1):218–226.
- ODG by MCG Treatment Guidelines [database online]. An MCG Health Company. Accessed on February 9, 2021.
- Amitiza® (lubiprostone) [package insert]. Bedminster, NJ: Sucampo Pharmaceuticals, Inc.; November 2020.