Elite Pharmaceuticals' once-daily ELI-154 outperforms two doses of OxyContin in phase 1 trial

By Lisa Kerner

Charlotte, N.C., June 27 - Elite Pharmaceuticals, Inc. said results from a second pilot phase 1 pharmacokinetic study demonstrated that once-daily oxycodone HCI (ELI-154) provided sustained blood levels over a 24-hour period when compared to two doses of OxyContin in the same period.

In addition, ELI-154 achieved similar levels of drug in the early and latter parts of the 24-hour period.

The study of 19 healthy males evaluated one 40 mg dose of ELI-154 administered at time zero and a 20 mg dose of OxyContin given at time zero and in 12 hours.

"We are very pleased with the continued positive clinical results of our pain products; first with our phase 1 study of ELI-216 and now with ELI-154," chairman and chief executive officer Bernard Berk said in a company news release.

"We are committed to advancing the development activities of both of these products and are looking forward to initiation of the phase 2 study, as soon as practically possible."

Located in Northvale, N.J., Elite is a specialty pharmaceutical company developing oral controlled-release products.

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