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The Food and Drug Administration (FDA) has approved Pizensy (lactitol; Sebela) for oral solution, an osmotic laxative, for the treatment of chronic idiopathic constipation (CIC) in adult patients.
The approval was based on efficacy data from two phase 3, double-blind, clinical trials (Study 1, Study 2). In Study 1, patients (N=594) were randomized to receive Pizensy or placebo for 6 months, while in Study 2, treatment with Pizensy was compared with lubiprostone 24mcg for 12 weeks. The primary end point for both studies was the proportion of patients with ≥3 complete spontaneous bowel movements (CSBMs) in a given week and an increase of ≥1 CSBM over baseline in the same week for ≥9 out of the 12 weeks, including ≥3 of the last 4 weeks.
Results from Study 1 showed that treatment with Pizensy was associated with a statistically significantly greater efficacy responder rate of 25% compared with 13% for placebo for weeks 9-12 (95% CI, 6.0-18.5; P <.05); this response was sustained during weeks 13 to 24. Moreover, improvements in the mean frequency of CSBMs/week were seen at week 1 with improvement generally maintained through week 12; the Pizensy group had a mean increase of 0.8 CSBM/week from baseline to week 12 over the placebo group. In Study 2, the frequency of CSBMs/week for Pizensy-treated patients was consistent with results from Study 1.
With regard to safety, Pizensy was assessed in a 12-month, open-label, uncontrolled study in 298 adults. The most common adverse reactions observed were upper respiratory tract infection, flatulence, diarrhea, increased blood creatinine phosphokinase, abdominal distension, and increased blood pressure.
Pizensy will be supplied as a powder for oral solution as 280 grams and 560 grams of lactitol in multi-dose bottles, as well as 28 unit-dose packets each containing 10 grams of lactitol. The product can be mixed with the patient’s fluid of choice and is taken once daily, preferably with meals. Patients can also adjust their dose based on stool consistency.
Pizensy is expected to be available in the second half of 2020.
For more information visit sebelapharma.com.
