FDA approves Relistor tablets to treat OIC in chronic non-cancer pain adults

Progenics Pharmaceuticals licensed development and commercialization rights for the product to Valeant Pharmaceuticals International.

Valeant anticipates to starts sales of Relistor tablets in the US in the third quarter of this year.

The approval was based on the data from a randomized, double-blind, phase 3 trial, which was carried out to assess once-daily dosing of 450 mg (n=200) methylnaltrexone (MNTX) tablets compared to placebo (n=201) in adults with chronic NCP.

In the 450 mg treatment group, MNTX tablets achieving the primary endpoint by showing statistically significant improvements in rescue-free bowel movement (RFBM) within 4 hours of administration over 28 days of dosing when compared to placebo treatment.

Valeant said the 450 mg treatment arm also achieved statistical significance for the first key secondary efficacy endpoint where a higher percentage of responders was observed with MNTX treatment as compared to placebo.

Efficacy of oral methylnaltrexone in the trial was comparable to that reported in clinical studies of subcutaneous methylnaltrexone in patients with chronic, non-cancer pain.

Valeant CEO Joseph Papa said: "Opioid-induced constipation represents a long-lasting and potentially debilitating side effect of opioid therapy for millions of patients suffering from chronic pain.

"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 Subcutaneous Injection (12 mg and 8 mg) was approved in 2008 to treat OIC in adults with advanced illness who are receiving palliative care. In 2014, it secured approval for the treatment of OIC in adults with chronic non-cancer pain.