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 www.relistor.com.
RELISTOR Development Programs
Subcutaneous Methylnaltrexone in chronic, non-malignant pain and OICA 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. About Salix 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.