Important Safety Information for RELISTOR
- RELISTOR is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction
- If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician
- Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients. Use RELISTOR with caution in patients with known or suspected lesions of the GI tract
- Use of RELISTOR has not been studied in patients with peritoneal catheters
- The most common adverse reactions reported with RELISTOR compared with placebo in clinical trials were abdominal pain (28.5% vs. 9.8%), flatulence (13.3% vs. 5.7%), nausea (11.5% vs. 4.9%), dizziness (7.3% vs. 2.4%), diarrhea (5.5% vs. 2.4%), and hyperhidrosis (6.7% vs. 6.5%)
- Safety and efficacy of RELISTOR have not been established in pediatric patients
RELISTOR full Prescribing Information for the U.S. is available at
RELISTOR Development Programs
Subcutaneous Methylnaltrexone in chronic, non-malignant pain and OIC
A 1,034-patient, one-year, open-label, international, phase 3 safety study to evaluate the long-term safety and tolerability of methylnaltrexone bromide subcutaneous injection in chronic, non-malignant pain patients with opioid-induced constipation was completed in September 2010. Efforts are underway to submit a supplemental New Drug Application for this potential indication to the FDA in the first half of 2011.
Oral Methylnaltrexone in chronic, non-malignant pain and OIC
A 700-patient, international, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of oral methylnaltrexone to treat opioid-induced constipation in chronic, non- malignant pain patients was initiated in September 2010, and is anticipated to complete enrollment by year-end 2011.
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the prevention and treatment of gastrointestinal diseases. Salix’s strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete any required development and regulatory submission of these products, and market them through the Company’s gastroenterology specialty sales and marketing team.