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  5. Drug Trial Snapshot: PIZENSY
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Drug Trial Snapshot: PIZENSY

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the PIZENSY Prescribing Information for complete information.

PIZENSY (lactitol)
Pi zen’ zee
Braintree Laboratories, Inc.
Approval date: February 12, 2020


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

PIZENSY is used to treat a type of constipation called chronic idiopathic constipation (CIC) in adults.

Idiopathic means that the cause of the constipation is unknown.

How is this drug used?

PIZENSY is a powder. The content of two packets or bottle caps should be mixed with a common beverage and taken once a day. The content of one packet or bottle cap can be taken once a day if the patient develops persistent loose stools with intake of two packets or bottle caps.

What are the benefits of this drug?

More patients who received PIZENSY experienced an increase in the number of complete spontaneous bowel movements (CSBMs) to at least 3 bowel movements per week than those who received placebo.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: PIZENSY worked similarly in men and women.
  • Race: PIZENSY worked similarly in White and Black or African American patients. The number of patients in other races was limited; therefore, differences in response among all races could not be determined.
  • Age: PIZENSY worked similarly in patients younger than 65 years and 65 years or older.

What are the possible side effects?

The most common side effects of PIZENSY are upper respiratory infections, gassiness, diarrhea, increased blood creatinine phosphokinase (a type of enzyme), belly distention and increased blood pressure.

Were there any differences in side effects among sex, race and age?

  • Sex: The occurrence of side effects was similar in men and women.
  • Race: The occurrence of side effects was similar in White and Black or African American patients. The number of patients in other races was limited; therefore, differences in side effects among all races could not be determined.
  • Age: The occurrence of side effects was similar in patients younger than 65 years and 65 years or older.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved PIZENSY based on evidence from a clinical trial (Trial 1/ NCT02819297) of 594 patients with CIC. This trial was conducted in the USA.

The FDA also considered other supportive evidence including data from Trial 2 (NCT02481947) which compared PIZENSY to previously approved drug (lubiprostone) for CIC, and Trial 3 (NCT02819310) in which patients used PIZENSY for one year as well as data from published literature.

The figure below summarizes how many men and women were in the clinical trial 1.

Figure 1. Demographics by Sex

Pie chart summarizing how many men and women were in the clinical trial. In total, 454 women (76%) and 140 men (24%) participated in the clinical trial.

FDA Review

Figure 2 below summarizes the percentage of patients by race in the clinical trial 1.

Figure 2. Demographics by Race

Pie chart summarizing the percentage of patients by race enrolled in the clinical trial. In total, 359 White (60%), 40 Asian (7%) and Black or African American 186 (31%) and 9 Other (2%))

*Includes American Indian or Alaska Native and Other
FDA Review

Figure 3 summarizes the percentage of patients by age enrolled in the clinical trial 1.

Figure 3. Demographics by Age

Pie charts summarizing how many individuals of certain age groups were enrolled in the clinical trial. In total, 435 (73%) were less than 65 years, 159 (27%) were 65 years and older.

FDA Review

Figure 4. Demographics by Ethnicity

Pie charts summarizing how many individuals of certain ethnicity were enrolled in the clinical trial. In total,  226 patients were Hispanic or Latino (38%), and 368 patients were not Hispanic or Latino (62%))

FDA Review

How were the trials designed?

The benefit and side effects of PIZENSY were evaluated in a clinical trial (Trial 1) of 594 patients with CIC. In this trial, patients received treatment with either PIZENSY or placebo once daily for 6 months. Neither the patients nor the health care providers knew which treatment was being given until after the trials were completed.

Based on the information from their electronic diaries, patients were evaluated for improvement in CSBMs during the first 12 weeks of the treatment.

The FDA considered additional data from 2 more trials for supportive evidence.

In the second trial (Trial 2) of three months duration, improvement in CSBMs was used to compare PIZENSY to the drug lubiprostone which was previously approved for CIC. The third trial (Trial 3) was used to collect the side effects in patients treated with PIZENSY for one year.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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