FDA approves one-month formulation of leuprolide for prostate cancer

By Alicia Ault

NEW YORK (Reuters Health) – Atrix Laboratories Inc. said on Thursday that it had received US Food and Drug Administration (FDA) approval for its Eligard 7.5 mg prostate cancer drug.

Formerly known as Leuprogel One-Month Depot, Eligard is injected just under the skin, usually above the hip. There, it turns into a biodegradable implant, and the active ingredient, leuprolide acetate, is gradually released. The 7.5 mg dose is delivered over a one-month period.

Atrix CEO David Bethune said in a conference call Thursday that in clinical trials, Eligard substantially reduced testosterone levels in men with hormone-responsive prostate cancer.

Ramon Perez, an Atrix investigator at the Urology Health Center in New Port Ritchie, Florida, believes that urologists are looking forward to a new technology. "Eligard gets dissolved in a predictable fashion for a predictable amount of time, so there is no guessing here," he said, adding that would make patients feel better and help repress tumors.

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