Elite Pharmaceuticals has completed the enrolment of patients and dosing in the Phase III efficacy trial for ELI-200, an abuse-deterrent opioid product.
The Phase III study is designed to assess the efficacy and safety of abuse deterrent ELI-200 to treat adults with moderate to severe pain following surgery.
Elite Pharmaceuticals president and CEO Nasrat Hakim said: "I am very pleased that we have completed enrolment, surgeries, and dosing for Elite’s Phase III trial for ELI-200.
"We expect the NDA submission for ELI-200 near year’s end, and in preparation for an ELI-200 launch in 2016, we are expanding our facility and working with our sales partner, Epic Pharma, on pre-launch activities."
The company has enrolled 163 patients at five clinical sites and plans to reveal the top-line efficacy and safety data from the trial by the end of this year.
The firm’s abuse deterrent technology ART is a multi-particulate capsule that contains opioid agonist and opioid antagonist naltrexone, which is primarily used in the management of alcohol dependence and opioid dependence.
Naltrexone has been developed 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.
When the product is taken as intended, the naltrexone will pass through the body unreleased and the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed.
The opioid antagonist will be released, when the multi-particulate beads are crushed or dissolved, said the company.