Elite Pharmaceuticals has started dosing first patients in a pivotal bioequivalence study of ELI-201, an abuse deterrent oxycodone/naltrexone product.
The primary objective of the open-label, single-dose, partially randomised crossover trial is to compare the bioavailability and establish bioequivalence of ELI-201 40mg controlled-release capsules to 40mg OxyContin controlled-release tablet.
Secondary objectives of the trial are to determine the bioavailability of oxycodone from ELI-201 under fasted and fed conditions and evaluate the safety and tolerability of the product.
Elite president and CEO Nasrat Hakim said: "We are pleased to have initiated our third key bioequivalence trial this year for Elite’s abuse-deterrent opioid products.
"Elite has a range of abuse deterrent products that use Elite’s proprietary pharmacological abuse deterrent technology and this is one of several abuse deterrent products currently under development by Elite.
"Our plans for the second half of this year include completing In Vitro Lab Abuse studies and In Vivo Human Abuse Liability studies and filing an NDA for ELI-200."
The bioequivalence trials are being carried out in partnership with Camargo Pharmaceutical Services.
Elite’s abuse deterrent technology is a multi-particulate capsule which contains an opioid agonist and naltrexone, an opioid antagonist.
Naltrexone is an opioid receptor antagonist used to manage alcohol and opioid dependence. The product passes through the body unreleased while the opioid agonist releases over time providing therapeutic pain relief.