The US Food and Drug Administration (FDA) has approved a new treatment for chronic idiopathic constipation (CIC).
The approval allows Braintree Laboratories to move forward with lactitol (Pizensy), an osmotic laxative indicated for the treatment of CIC in adults for a recommended dosage of 20 grams orally daily.
The FDA suggests reducing the dosage to 10 grams daily for persistent loose stools.
The approval is based on an 807-patient, six-month placebo-controlled trial, a three-month active-controlled trial, and a one-year uncontrolled safety study.
In clinical testing, the most common adverse reactions were upper respiratory tract infections, flatulence, diarrhea, increased blood creatinine phosphokinase, abdominal distension, and increased blood pressure.
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.
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