Lactitol is produced by hydrogenation of lactose using Raney nickel catalyst. The product can be obtained as an anhydrous, monohydrate, or dihydrate. Two manufacturers, Danisco and Purac Biochem, produce about 10,000 tons/y.[1]
Lactitol is listed as an excipient in some prescription drugs.[3][4]
Lactitol is a laxative and is used to prevent or treat constipation,[5] e.g., under the trade name Importal.[6][7]
In February 2020, Lactitol was approved for use in the United States as an osmotic laxative for the treatment of chronic idiopathic constipation (CIC) in adults.[8][9][10]
Lactitol in combination with Ispaghula husk is an approved combination for idiopathic constipation as a laxative and is used to prevent or treat constipation.[medical citation needed]
Like other sugar alcohols, lactitol causes cramping, flatulence, and diarrhea in some individuals who consume it. These effects arise because humans lack a suitable beta-galactosidase in the upper gastrointestinal (GI) tract, and a majority of ingested lactitol reaches the large intestine,[11] where it then becomes fermentable to gut microbes (prebiotic) and can pull water into the gut by osmosis.[medical citation needed] For these reasons, medical advice is often sought before their use.
History
The U.S. Food and Drug Administration (FDA) approved Pizensy based on evidence from a clinical trial (Trial 1/ NCT02819297) of 594 subjects with CIC conducted in the United States.[10] The FDA also considered other supportive evidence including data from Trial 2 (NCT02481947) which compared Pizensy to previously approved drug (lubiprostone) for CIC, and Trial 3 (NCT02819310) in which subjects used Pizensy for one year as well as data from published literature.[10]
The benefit and side effects of Pizensy were evaluated in a clinical trial (Trial 1) of 594 subjects with CIC.[10] In this trial, subjects received treatment with either Pizensy or placebo once daily for 6 months.[10] Neither the subjects nor the health care providers knew which treatment was being given until after the trials were completed.[10]
In the second trial (Trial 2) of three months duration, improvement in CSBMs was used to compare Pizensy to the drug lubiprostone which was previously approved for CIC.[10] The third trial (Trial 3) was used to collect the side effects in subjects treated with Pizensy for one year.[10]
