SAN DIEGO — The Food and Drug Administration has accepted a regulatory application for an opioid painkiller made by Zogenix, the company said Monday.
The drug maker announced the FDA's acceptance of its application for Zohydro (hydrocodone bitartrate) extended-release capsules, designed for moderate to severe chronic pain. The company expects the FDA to decide whether or not to approve the drug by March 1, 2013.
"We are pleased with the decision by the FDA to accept our submission for filing and look forward to working with them throughout the regulatory process," Zogenix president and CEO Stephen Farr said.
Farr said that if the drug is approved, it will be classified by the Drug Enforcement Agency as a Schedule II controlled substance and will have a risk evaluation and mitigation strategy, or REMS, which he said would be consistent with the recently introduced FDA-approved REMS for extended-release and long-acting opioids.