EMA recommends new indication for Relistor in Europe

The Committee for Medicine Products for Human Use of the European Medicines Agency has adopted a positive opinion regarding a new indication for Relistor subcutaneous injection for opioid-induced constipation in adult patients who have insufficient response to laxatives, the manufacturer announced.

The committee has also recommended a 1-year extension of data/marketing protection for Relistor (Valeant Pharmaceuticals; Progenics Pharmaceuticals, [methylnaltrexone bromide]), amounting to 11 years from date of approval, acknowledging the drug “offers a major contribution to patient care in comparison to existing therapies,” the release said.

“The positive CHMP opinion brings Relistor one step closer to providing a treatment for the millions of patients in Europe who suffer from debilitating constipation while taking opioids for chronic noncancer pain,” Mark Baker, CEO of Progenics, said in the release. “Relistor offers a meaningful benefit to patients who are unable to manage their constipation with less effective laxative therapies.”

The committee’s positive opinion will be reviewed by the European Commission, upon whose approval Relistor is expected to be immediately available to patients using opioids to control chronic noncancer pain.

The committee’s opinion “recognizes the clinical benefit of Relistor, which treats the underlying cause of [opioid-induced constipation] without interfering with the centrally acting analgesic properties of the opioid,” Tage Ramakrishna, MD, chief medical officer of Valeant, said in the release. “We are committed to realizing the full potential of this important franchise, and if approved, we will work quickly to bring this needed medicine to European patients.”

Disclosure: Baker is an employee of Progenics. Ramakrishna is an employee of Valeant Pharmaceuticals.