FDA Approves Salix Pharmaceuticals’ Relistor sNDA for New Indication
Salix Pharmaceuticals has convinced the FDA to reverse its 2012 stance blocking the company’s sNDA for an expanded use of its opioid-induced constipation drug Relistor.
The agency’s decision to accept data submitted in the sNDA paves the way for the FDA to approve Relistor (methylnatrexone bromide) for treatment of OIC in patients taking opioids for non-cancer pain. The drug already is approved for OIC in palliative care patients for whom laxatives haven’t worked.
In July 2012, the FDA had requested that Salix conduct a large, controlled chronic administration cardiovascular safety trial for the new indication. Salix appealed the decision, claiming that enrolling enough patients in such a trial would be lengthy and costly and that preclinical, clinical and postmarketing data showed that the drug had an acceptable safety profile.
That position generally was confirmed at a June FDA advisory committee meeting, which determined that heart attacks resulting from one specific OIC drug were not sufficient to recommend large cardiovascular outcomes safety trials for all drugs in this class. The panelists recommended postmarketing observational studies instead.
Salix will submit additional information, including potential labeling and a proposal for at least one postmarketing observational cohort study to compare the incidence of major adverse cardiovascular events in chronic non-cancer pain patients taking Relistor versus a comparator drug, said Salix Chief Development Officer Bill Forbes on Monday.
The drugmaker bought Relistor’s global rights, excluding Japan, from Progenics in February 2011. The drug generated roughly $6.7 million in 2013. — Lena Freund
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.