Priority Review for Elite Pain Drug NDA

FDA has accepted for priority review an Elite Pharmaceuticals NDA for SequestOX (oxycodone hydrochloride and naltrexone), an opioid abuse-deterrent candidate for managing moderate to severe pain where the use of an opioid analgesic is appropriate. The agency has set a 7/14 user fee review target date.

The company says its proprietary abuse deterrent technology, ART, uses a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in managing alcohol and opioid dependence.  “When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases as intended providing therapeutic pain relief for which it is prescribed,” it says. “If the multi-particulate beads are crushed or dissolved, the opioid antagonist is designed to release and so block the effects of active opioid agonist.”