RELISTOR rapidly relieved OIC in 2 randomized, double-blind, placebo-controlled clinical studies
PROVEN RESPONSE: 62% and 48% of patients treated with RELISTOR had a bowel movement within 4 hours of the first injection.1
RAPID RESPONSE: Approximately 30% of patients reported a bowel movement within 30 minutes of a dose of RELISTOR in both studies.1
- In both studies, patients had advanced illness (a primary diagnosis of incurable cancer or other advanced illnesses, such as end-stage cardiovascular disease or end-stage COPD) with a life expectancy of less than 6 months and received care to control their symptoms. Prior to screening, patients had been receiving palliative opioid therapy (median daily baseline oral morphine equivalent dose = 172 mg).1
- Patients maintained their regular laxative regimen in addition to RELISTOR or placebo throughout the studies. Rescue laxatives were prohibited from 4 hours before to 4 hours after taking an injection of medication.1
STUDY 1: All patients had OIC (no bowel movement within 2 days) on stable laxatives for at least 3 days prior to treatment in a single-dose study.1,3
STUDY 2: All patients had OIC (either <3 bowel movements in the preceding week or no bowel movement within 2 days) on stable laxatives for at least 3 days prior to receiving either RELISTOR or placebo every other day for 2 weeks.1,3
STUDY 2: A double-blind, placebo-controlled study of RELISTOR given every other day for 2 weeks
- 52% of patients responded to at least 2 of 4 doses of RELISTOR given every other day for the first week vs 9% for placebo.1
- Response was consistent from dose 1 through 7 over the course of the 2-week double-blind period.1
Open-label experience
- In both studies, patients who completed the double-blind periods could enroll in open-label extensions in which RELISTOR was given as needed, but no more frequently than 1 dose in a 24-hour period, for up to 3 or 4 months.1,3,4
Next: Safety & Tolerability »
