Currently Enrolling Trials
Pizensy (lactitol) is an osmotic laxative.
Pizensy is specifically indicated for the treatment of chronic idiopathic constipation in adults.
Pizensy is supplied as an off-white crystalline powder for oral solution. The recommended daily dosage is 20 grams (mixed with 4 to 8 ounces of water, juice, coffee, tea, or soda), preferably with meals. The dosage should be reduced to 10 grams daily in patients who have persistent loose stools.
Mechanism of Action
Pizensy (lactitol) exerts an osmotic effect, causing the influx of water into the small intestine leading to a laxative effect in the colon.
Adverse effects associated with the use of Pizensy may include, but are not limited to, the following:
- upper respiratory tract infections
- increased blood creatinine phosphokinase
- abdominal distension
- increased blood pressure
Clinical Trial Results
The FDA approval of Pizensy was based on a 6-month placebo-controlled trial, a 3-month active-controlled trial, and a 1-year uncontrolled safety study. 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. Significantly more patients using lactitol responded to treatment compared with placebo (25% vs 13%). A responder was defined as those patients who had at least three complete spontaneous bowel movements (CSBM) in a given week and an increase of at least one CSBM from baseline in the same week for at least 9 weeks out of the first 12-week treatment period and at least 3 of the last 4 weeks.