The FDA has set a target action date under the Prescription Drug User Fee Act ("PDUFA") of July 14, 2016.
SequestOxTM 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.
"The FDA’s decision to grant Priority Review to the SequestOxTM submission is an important milestone for Elite and an important step toward providing a new treatment option for physicians and patients that may deter some of the common methods of opioid abuse," said Nasrat Hakim, President and Chief Executive Officer of Elite.
"I am pleased with the targeted PDUFA date and we look forward to the FDA’s review of our submission."
About Elite’s Abuse Deterrent Technology
Elite’s proprietary abuse deterrent technology, ART, is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol dependence 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.
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. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to the same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers.
Elite’s pharmacological approach to abuse-deterrence can be applied to a wide range of opioids used today in pain management.