Elite Pharma files NDA at FDA for SequestOX (ELI-200) to treat moderate to severe pain.

Elite Pharmaceuticals, Inc.has announced that the New Drug Application (NDA) for SequestOX (ELI-200), Elite's lead opioid abuse-deterrent candidate for the management of moderate to severe pain where the use of an opioid analgesic is appropriate, has been accepted and granted priority review by the FDA.

The FDA has set a target action date under the Prescription Drug User Fee Act ("PDUFA") of July 14, 2016. SequestOx is an immediate-release Oxycodone Hydrochloride containing sequestered Naltrexone which incorporates 5 mg, 10 mg, 15 mg, 20 mg and 30 mg doses of oxycodone into capsules.