Cardiome says oral RSD1235 safe, effective in trial

By Elaine Rigoli

Tampa, Fla., May 5 - Cardiome Pharma Corp. said data from a phase 1 study for RSD1235 (oral) for the prevention of recurrence of atrial fibrillation showed the product to be safe and well-tolerated across all dose levels.

Additionally, dose proportional increases in plasma levels of RSD1235 were seen with steady state plasma levels reached within three to four days, the company said in a news release.

The maximum dose given for seven days was 900 mg twice daily (1,800 mg/day), yielding blood levels of RSD1235 approaching peak blood levels seen in intravenous dosing, the release said.

The formulation provided sustained blood levels of drug over an interval deemed suitable for chronic-use oral therapy.

QT interval is a measure of the time required for depolarization and repolarization of the heart for each heartbeat.

A phase 2a pilot study for RSD1235 (oral) began in December 2005. The double-blind, placebo-controlled, randomized, dose-ranging study will measure the safety and efficacy of RSD1235 over 28 days of oral dosing in patients at risk of recurrent atrial fibrillation, the release said.

Interim results from the study for the 300 mg dosing group are expected in mid-2006. Final results, including data from a 600 mg twice-daily dose in the second stage, will be available by the end of 2006.

Cardiome is a product-focused cardiovascular drug-development company based in Vancouver, B.C.

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