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.
The primary efficacy analysis was based on the first 12 weeks of the 6-month treatment period among 594 patients, with 291 in the lactitol arm and 303 in the placebo arm.
The most common adverse reactions encountered were upper respiratory tract infections, flatulence, diarrhea, increased blood creatinine phosphokinase, abdominal distension, and increased blood pressure.
The clinical trials for lactitol were conducted under widely varying conditions, meaning adverse reaction rates observed cannot be directly compared to rates in the clinical trials of another drugs and may not reflect the rates observed in practice.
The drug is minimally absorbed systemically following oral administration. However, it is unknown whether the minimal systemic
development and health benefits of breastfeeding should be considered along with the mother's clinical need for lactitol.
In addition to this lactitol has been found to be safe and effective in children.
For prescribing information online