Relistor Tablets Launched by Valeant, Progenics

Valeant and Progenics Pharmaceuticals have just launched an oral formulation of methylnaltrexone bromide (Relistor) in the United States.

Relistor now comes in 450 mg once-daily tablets approved by the FDA to treat opioid-induced constipation (OIC) in adults with chronic noncancer pain. Relistor subcutaneous injection (12 mg and 8 mg) is also available to treat OIC in patients with advanced illness and chronic noncancer related pain.

“This new method of delivery for Relistor offers health care professionals a novel alternative to address the treatment of OIC—a growing need in pain management,” said Valeant Chief Executive Officer Joseph C. Papa in a press release.

Relistor tablets are contraindicated in individuals with known or suspected gastrointestinal (GI) obstruction, as well as those with an increased risk of recurrent obstruction. Instances of GI perforation have been reported in adults with OIC and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract.

For this reason, health care professionals should take into account the overall risk-benefit profile when recommending Relistor to patients with these conditions or other conditions that might result in impaired integrity of the GI tract wall. Health care professionals should also monitor for the development of severe, persistent, or worsening abdominal pain, and discontinue Relistor use in patients who develop this symptom.

Concomitant use of Relistor with other opioid antagonists should be avoided because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.

The most common adverse effects associated with Relistor tablets are abdominal pain, diarrhea, headaches, abdominal distention, hyperhidrosis, anxiety, muscle spasms, rhinorrhea, and chills.