The new drug is an osmotic laxative for the treatment of chronic idiopathic constipation in adults.
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.
The efficacy of the medication 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 for 594 patients.
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 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.