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FDA approves Relistor tablets for OIC in adults with chronic noncancer pain
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The FDA has approved 450 mg once daily Relistor tablets for the treatment of opioid-induced constipation in adults with chronic noncancer pain, the manufacturer announced.
“Opioid-induced constipation represents a long-lasting and potentially debilitating side effect of opioid therapy for millions of patients suffering from chronic pain,” Joseph C. Papa, CEO of Valeant, said in a press release. “We believe oral Relistor represents a new alternative treatment for OIC, and we look forward to introducing the more convenient oral formulation as soon as practicable.”
Relistor (methylnaltrexone bromide) subcutaneous injection was previously FDA approved for OIC in adults with advanced illness receiving palliative care in 2008, and for OIC in adults with chronic noncancer pain in 2014.
The approval for Relistor tablets follows the results of a phase 3 clinical trial of adults with chronic noncancer pain, in which 200 were randomly assigned to receive 450 mg Relistor tablets and 201 to receive placebo for 28 days. The primary endpoint was achieved, with the Relistor group achieving significant improvements in rescue-free bowel movement within 4 hours. There was also a higher proportion of responders in the treatment group, the safety profile was comparable to placebo, and the overall efficacy of the tablets was comparable to previous reports of efficacy for the subcutaneous injections in patients with chronic noncancer pain.
“Relistor has a unique mechanism of action that binds to mu-opioid receptors without impacting the opioid-mediated analgesic effects on the central nervous system,” Richard L. Rauck, MD, medical director of the Center for Clinical Research, president of the Carolinas Pain Institute, president of the Sceptor Pain Foundation and immediate past president of the World Institute of Pain, said in the press release. “This represents a true breakthrough in the treatment of OIC, and addresses a large and growing need in the field of pain management.”
Valeant plans to begin U.S. sales of Relistor tablets in Q3 of this year.
Disclosures: Papa is employed by Valeant. Healio Gastroenterology was unable to confirm Rauck’s relevant financial disclosures at the time of publication.