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Sebela Pharmaceuticals has announced the FDA approval of lactitol (Pizensy), an oral solution for treating chronic idiopathic constipation (CIC) in adults, according to their press release.
Lactitol is a simple monosaccharide sugar alcohol taken once per day that generates an osmotic effect in order to trigger the influx of water into the small intestine and consequently assuage CIC symptoms. The new treatment will be available later this year.
Lactitol is different from other CIC prescriptions in that rather than a solid form oral dose, lactitol offers the ability to mix the medication with a patient’s preferred fluid, including water, juice, coffee, tea, and soda. Lactitol also extends patients the freedom of choosing what time of day to take it, as well as allowing patients to adjust their dose of the product. During clinical trials, approximately 25% of participants had the option of reducing dosage.
CIC is a complex gastrointestinal disorder that affects approximately 33 million Americans and an estimated 14% of the population around the world. Nearly 4.7 million brand prescriptions were written for CIC-alleviating products last year. It is characterized by symptoms, of which there is no identifiable cause, that range from less than 3 bowel movements per week to hard-to-pass or incomplete bowel movements.
The FDA’s approval of lactitol stems from 3 phase 3 clinical trials conducted by Sebela. Over 1400 patients engaged in a 6-month, double-blind, placebo-controlled study, a 12-week, blind head-to-head study against lubiprostone (AMITIZA), and a 12-month, open-label, chronic use study.
During the first 12-week course of treatment, lactitol demonstrated significant efficacy compared with placebo, according to the study. Patients treated with the new solution experienced positive results in terms of stool frequency–measured by the number of spontaneous and complete spontaneous bowel movement during the course of a week–and stool consistency, as measured by using the Bristol Stool Form Scale.
The most frequent adverse effects (AEs) of lactitol observed during the clinical trials included upper respiratory tract infection (URI) at a 9% rate. Those treated with placebo were diagnosed with URIs at a 6% rate. Other less frequent AEs included flatulence and diarrhea, and the study expressed low discontinuation rates for lactitol at 4% compared with placebo at 3%, according to the data.
“The approval of Pizensy represents a major step forward in treatment options for CIC. Pizensy will be the only FDA approved product which the patient can self-titrate based on their own results for stool consistency,” said Jack A. Di Palma, MD, professor of medicine and fellowship program director of the division of gastroenterology at the University of South Alabama College of Medicine and past-president of the American College of Gastroenterology. “Pizensy will allow practitioners and patients to jointly take control of their condition using a product with the same proven and safe mechanism of action as we have seen in bowel prep products such as SUPREP® Bowel Prep Kit.”
1. Sebela Pharmaceuticals Announces FDA Approval of Pizensy™ for oral solution for the Treatment of Chronic Idiopathic Constipation in Adults [news release]. Sebela Pharmaceutical’s website. https://sebelapharma.com/press/pizensy-press-release.pdf. Accessed March 11, 2020.