Elite Pharmaceuticals to Begin Study of Oxycodone Product

Elite Pharmaceuticals has reached an agreement with the FDA under a special protocol assessment on a Phase III trial of ELI-216, the company’s abuse-deterrent Oxycodone product.

The study is a randomized-withdrawal, placebo-controlled, double-blind trial whose primary objective is to evaluate the safety and efficacy of ELI-216 controlled-release capsules administered once daily compared with placebo in the treatment of chronic pain associated with osteoarthritis, Elite said. The drug is formulated to deter illegal use.

This study will enroll approximately 150 patients in each treatment group.