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Breaking News, Trials & Filings

Elite Begins Bioequivalence Study

Will test abuse-deterrent formulation

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Elite Pharmaceuticals has begun dosing of a pilot bioequivalence study in healthy volunteers for ELI-201, the company’s twice daily abuse deterrent oxycodone/naltrexone product.

A pivotal bioequivalence study for a second abuse deterrent product is scheduled to begin dosing in January 2014, and the pivotal bioequivalence study for ELI-201 is scheduled to begin dosing in March 2014. The bioequivalence studies for these opioid abuse deterrent products are being conducted under the direction of Camargo Pharmaceutical Services.

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