FDA approves new drug for chronic idiopathic constipation
The US Food and Drug Administration (FDA) has approved Lactitol as new treatment for chronic idiopathic constipation (CIC).
Chronic idiopathic constipation is a diagnosis given to those who experience persistent constipation and for whom there is no structural or biochemical explanation.
Lactitol (Pizensy) the approved drug is an osmotic laxative indicated for the treatment of CIC in adults for a recommended dosage of 20 grams orally daily.
The approval has been granted to the Braintree Laboratories.
The FDA suggests reducing the dosage to 10 grams daily for persistent loose stools.
The approval was based on results of a 6-month placebo-controlled trial, a 3-month active-controlled trial, and a 1-year uncontrolled safety study.
The efficacy of the drug was assessed using a responder analysis and change-from-baseline in the complete spontaneous bowel movements endpoint, using information provided by patients after each bowel movement using an electronic diary.
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