Convenient once-daily RELISTOR dosing1
RELISTOR is available as an oral tablet for adult patients with opioid-induced constipation (OIC) with chronic non-cancer pain (CNCP), including patients with chronic pain related to prior cancer or its treatment who do not require frequent (eg, weekly) opioid dosage escalation.1
RELISTOR tablets
Convenient once-daily RELISTOR dosing1
RELISTOR is available as an oral tablet for adult patients with opioid-induced constipation (OIC) with chronic non-cancer pain (CNCP), including patients with chronic pain related to prior cancer or its treatment who do not require frequent (eg, weekly) opioid dosage escalation.1
RELISTOR helps restore gut function and can increase the number of spontaneous bowel movements (SBMs)1,2
RELISTOR helps restore gut function and can increase the number of spontaneous bowel movements (SBMs)1,2
Secondary endpoint, responder analysis: Significantly more patients taking RELISTOR experienced at least 3 SBMs per week1,2,*
SIGNIFICANT
DIFFERENCE
P=.0052
Percentage of patients
SIGNIFICANT
DIFFERENCE
P=.00522
Percentage of patients
@lchValue>
*Responder is defined as a patient with 3 or more SBMs per week, with an increase of 1 or more SBMs per week over baseline, for 3 or more out of the first 4 weeks of the treatment period. All patients had OIC, defined as less than 3 SBMs per week and at least 1 additional symptom of constipation.1,2
†Three RELISTOR 150-mg tablets (450 mg total) once daily in the morning with water on an empty stomach at least 30 minutes before the first meal of the day.1
‡SBM is defined as a bowel movement without the use of any laxative in the previous 24 hours.1
*Responder is defined as a patient with 3 or more SBMs per week, with an increase of 1 or more SBMs per week over baseline, for 3 or more out of the first 4 weeks of the treatment period. All patients had OIC, defined as less than 3 SBMs per week and at least 1 additional symptom of constipation.1,2
†Three RELISTOR 150-mg tablets (450 mg total) once daily in the morning with water on an empty stomach at least 30 minutes before the first meal of the day.1
‡SBM is defined as a bowel movement without the use of any laxative in the previous 24 hours.1
Primary endpoint results:
More patients met the primary endpoint of mean percentage of dosing days that resulted in an RFBM within
4
during weeks 1 to 42,§
of dosing days in the RELISTOR 450 mg/day treatment group (n=200)2
VS
of dosing days in the placebo group (n=201)2
Percentages indicative of the number of patients who met the primary endpoint (P<.0001)2
RFBM, rescue-free bowel movement.
§The primary endpoint was the mean percentage of dosing days resulting in a SBM within 4 hours of dosing during the 4-week, double-blind period compared with placebo.2
Additional finding (non-primary or secondary endpoint)
- 24% of patients experienced a SBM within 4 hours of the first dose of RELISTOR (450 mg/day) oral tablets vs placebo (8%)2
- SBM within 4 hours was an exploratory endpoint only and, therefore, results should be interpreted with caution2
Convenient once-daily oral therapy1
- Three (3) 150-mg tablets (450 mg total)
- RELISTOR therapy should be continued only during opioid use1
Not actual size.
@lchValue>
RELISTOR subcutaneous injection provides OIC treatment for patients with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care1
RELISTOR tablets have a well-established safety profile1
Most common adverse reactions
In the 4-week, double-blind, placebo-controlled period of the clinical study in patients with OIC and CNCP (n=401) (Study 1)1
ADVERSE REACTIONS|| | RELISTOR TABLETS (n=200) |
PLACEBO (n=201) |
---|---|---|
ABDOMINAL PAIN¶ | 14% | 10% |
DIARRHEA | 5% | 2% |
HEADACHE | 4% | 3% |
ABDOMINAL DISTENTION | 4% | 2% |
VOMITING | 3% | 2% |
HYPERHIDROSIS | 3% | 1% |
ANXIETY | 2% | 1% |
MUSCLE SPASMS | 2% | 1% |
RHINORRHEA | 2% | 1% |
CHILLS | 2% | 0% |
ADVERSE REACTIONS|| | |
---|---|
ABDOMINAL PAIN¶ | |
RELISTOR TABLETS (n=200) |
14% |
Placebo (n=201) | 10% |
DIARRHEA | |
RELISTOR TABLETS (n=200) |
5% |
Placebo (n=201) | 2% |
HEADACHE | |
RELISTOR TABLETS (n=200) |
4% |
Placebo (n=201) | 3% |
ABDOMINAL DISTENTION | |
RELISTOR TABLETS (n=200) |
4% |
Placebo (n=201) | 2% |
VOMITING | |
RELISTOR TABLETS (n=200) |
3% |
Placebo (n=201) | 2% |
HYPERHIDROSIS | |
RELISTOR TABLETS (n=200) |
3% |
Placebo (n=201) | 1% |
ANXIETY | |
RELISTOR TABLETS (n=200) |
2% |
Placebo (n=201) | 1% |
MUSCLE SPASMS | |
RELISTOR TABLETS (n=200) |
2% |
Placebo (n=201) | 1% |
RHINORRHEA | |
RELISTOR TABLETS (n=200) |
2% |
Placebo (n=201) | 1% |
CHILLS | |
RELISTOR TABLETS (n=200) |
2% |
Placebo (n=201)) | 0% |
||Adverse reactions occurring in at least 2% of patients receiving 3 RELISTOR 150-mg tablets (450 mg total) 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
- Adverse reactions of abdominal pain, diarrhea, hyperhidrosis, anxiety, rhinorrhea, and chills may reflect symptoms of opioid withdrawal1
- For additional Important Safety Information, please see the sidebar to the right
REFERENCES: 1. RELISTOR [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals. 2. Rauck R, Slatkin NE, Stambler N, et al. Randomized, double-blind trial of oral methylnaltrexone for the treatment of opioid-induced constipation in patients with chronic noncancer pain. Pain Pract. 2017;17(6):820-828.