MoviPrep® produces a watery stool leading to cleansing of the colon. The osmotic activity of polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid, when taken with 1 liter of additional clear fluid, usually results in no net absorption or excretion of ions or water.

The pharmacokinetics of MoviPrep® have not been studied in patients with renal or hepatic insufficiency.

Clinical Studies

The colon cleansing efficacy and safety of MoviPrep® was evaluated in two randomized, actively-controlled, multi-center, investigator-blinded, phase 3 trials in patients scheduled to have an elective colonoscopy.

In the first study, patients were randomized to one of the following two colon preparation treatments: 1) 2 liters of MoviPrep® with 1 additional liter of clear fluid split into two doses (during the evening before and the morning of the colonoscopy) and 2) 4 liters of polyethylene glycol plus electrolytes solution (4L PEG + E) split into two doses (during the evening before and the morning of the colonoscopy). Patients were allowed to have a morning breakfast, a light lunch, clear soup and/or plain yogurt for dinner. Dinner had to be completed at least one hour prior to initiation of the colon preparation administration.

The primary efficacy endpoint was the proportion of patients with effective colon cleansing as judged by blinded gastroenterologists on the basis of videotapes recorded during the colonoscopy. The blinded gastroenterologists graded the colon cleansing twice (during introduction and withdrawal of the colonoscope) and the poorer of the two assessments was used in the primary efficacy analysis.

The efficacy analysis included 308 adult patients who had an elective colonoscopy. Patients ranged in age from 18 to 88 years old (mean age about 59 years old) with 52% female and 48% male patients. Table 1 displays the results.

Table 1: Effectiveness of Overall Colon Cleansing in the Study of MoviPrep® vs 4 Liter Polyethylene Glycol plus Electrolytes Solution

In the second study, patients were randomized to one of the following two colon preparation treatments: 1) 2 liters of MoviPrep® with 1 additional liter of clear fluid in the evening prior to the colonoscopy and 2) 90 mL of oral sodium phosphate solution (90 mL OSPS) with at least 2 liters of additional clear fluid during the day and evening prior to the colonoscopy. Patients randomized to MoviPrep® therapy were allowed to have a morning breakfast; a light lunch; and clear soup and/or plain yogurt for dinner. Dinner had to be completed at least one hour prior to initiation of the colon preparation administration.

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