RELISTOR injection provided reliable and rapid relief1,10

In a clinical study of adult CNCP patients with OIC

PERCENTAGE OF PATIENTS

STUDY DESIGN: Study 2 was a 4-week, multicenter, double-blind, randomized, placebo-controlled, phase 3 study. The efficacy of RELISTOR injection was evaluated in 312 patients with CNCP for which they were taking opioids. All patients had OIC, defined as <3 SBMs per week and at least one additional symptom of constipation.1

†A responder was defined as a patient with 3 or more SBMs per week for each of the 4 weeks in the double-blind period.1

  • RELISTOR injection increased the number of weekly SBMs vs placebo1,10
  • SBM‡ achieved within 4 hours of first dose1,10
    • – 33% of patients taking RELISTOR 12-mg injection (n=150)1,10
    • – 10% placebo (n=162)1,10
    • – Significant difference (P<.001)10

‡SBM is defined as bowel movement without the use of any laxative in previous 24 hours.1

Significantly more patients taking RELISTOR injection experienced an SBM§ within 4 hours of the first dose1,12,13

In 2 clinical studies of OIC in adult patients with advanced illness, including many patients with active cancer

PERCENTAGE OF PATIENTS

STUDY DESIGNS: IN ADULT PATIENTS WITH ADVANCED ILLNESS

STUDY 4 was a multicenter, double-blind, randomized, placebo-controlled study; 154 patients with advanced illness and OIC received a single subcutaneous dose of RELISTOR injection or placebo.1,12

STUDY 5 was a 2-week, multicenter, double-blind, randomized, placebo-controlled trial followed by a subsequent 3-month, open-label extension study. The efficacy of RELISTOR was evaluated in 133 patients.1,13

  • In adult patients with advanced illness, RELISTOR injection delivered rapid SBMs1,12,13,§
  • In Study 5, significantly more patients in the RELISTOR injection cohort (52%; n=62) experienced laxation within the first 4 hours after at least 2 of the first 4 doses vs 9% for placebo (n=71; P<.0001)1,13

Approximately 50% of patients who had an SBM within 4 hours of first dose in Studies 4 and 5 experienced an SBM§ within 30 minutes12,13

§SBM is defined as laxation without the use of a rescue laxative.12,13

§SBM is defined as laxation without the use of a rescue laxative.12,13

RELISTOR injection has a well-established safety profile in patients with advanced illness and CNCP1

Adverse reactions in a 4-week, double-blind, placebo-controlled period of clinical study of RELISTOR injection in adult patients with OIC and CNCP (Study 2)1

||Adverse reactions occurring in at least 1% of patients receiving RELISTOR injection 12 mg subcutaneously once daily and at an incidence greater than placebo.1

Includes: abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort, and abdominal tenderness.1

  • The safety of RELISTOR injection was also evaluated in Study 3, a 48-week, open-label, uncontrolled trial in 1034 adult patients with OIC and CNCP1
    • – The adverse reactions seen in this study were similar to those observed during the 4-week, double-blind period of Study 2

Adverse reactions from all doses in double-blind, placebo-controlled clinical studies of RELISTOR injection in adult patients with OIC and advanced illness (Studies 4 and 5)1

#Adverse reactions occurring in at least 5% of patients receiving all doses of RELISTOR injection (0.075, 0.15, and 0.3 mg/kg) and at an incidence greater than placebo.1

**Includes: abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort, and abdominal tenderness.

  • Adverse reactions of abdominal pain, diarrhea, hyperhidrosis, anxiety, rhinorrhea, and chillsmay reflect symptoms of opioid withdrawal1
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IMPORTANT SAFETY INFORMATION
  • RELISTOR tablets and injection are contraindicated in patients with known or suspected mechanical gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.
INDICATIONS
  • RELISTOR® is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
IMPORTANT SAFETY INFORMATION
  • RELISTOR tablets and injection are contraindicated in patients with known or suspected mechanical gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.