From rxpgnews.com
RSD1235 holds promise in preventing recurrent atrial fibrillation
By Cardiome Pharma Corp.
May 6, 2006, 00:55
Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today reported additional results, including QT data, from a Phase 1 study for RSD1235 (oral) for the prevention of recurrence of atrial fibrillation. Initial results from this study were announced in a press release dated August 31, 2005.
The study's trial design tested tolerability and pharmacokinetics of RSD1235 (oral) with repeat oral dosing in healthy volunteers. Orally- administered RSD1235 was found to be safe and well-tolerated across all dose levels. Dose proportional increases in plasma levels of RSD1235 were seen with steady state plasma levels reached within 3-4 days. The maximum dose given for 7 days was 900mg twice daily (1,800mg/day), yielding blood levels of RSD1235 approaching peak blood levels seen in IV dosing. The formulation provided sustained blood levels of drug over an interval deemed suitable for chronic- use oral therapy. No clinically relevant changes were found in clinical laboratory, vital signs or ECG measurements, and there were no serious adverse events.
QT interval is a measure of the time required for depolarization and repolarization of the heart for each heartbeat. Prolongation of the QT interval can be associated with life-threatening drug-induced side effects such as Torsades de Pointes, and has traditionally presented a significant challenge for antiarrhythmic therapy. QT interval was not significantly changed when measured at maximal plasma levels (Cmax) following 7 days of treatment with RSD1235 (oral).
----------------------------------------------------
Dose QT at Baseline QT at Cmax(x)
------------------------------------------------------------
300mg b.i.d. 396 +/- 25 msec 394 +/- 13 msec
------------------------------------------------------------
600mg b.i.d. 402 +/- 19 msec 405 +/- 18 msec
------------------------------------------------------------
900mg b.i.d. 413 +/- 19 msec 408 +/- 25 msec
------------------------------------------------------------
(x) Approximate time of Cmax on Day 7 (2 hours after dosing)
Cardiome expects the data from this study to be presented at a future scientific conference.
A Phase 2a pilot study for RSD1235 (oral) was initiated 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. It is expected that the majority of patients enrolled will have experienced atrial fibrillation for greater than 30 days and less than 180 days in duration. The study will enroll approximately 180 patients across 75 centres in Canada, U.S. and Europe. Interim results from the study for the 300mg 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 anticipates initiating a Phase 2b study of oral RSD1235 in the second half of 2006.
All rights reserved by www.rxpgnews.com