Merck-Cardiome heart rhythm drug meets study goals

Merck & Co. and Cardiome Pharma Corp. said Friday that their drug candidate Brinavess met its goal in a late-stage clinical study, as it was better at restoring a steady heartbeat than an older drug use for the same purpose.

The trial compared Brinavess to the standard drug, amiodarone, as a treatment for atrial fibrillation. Atrial fibrillation is a condition in which the upper chambers of the heart beat rapidly and ineffectively. Merck and Cardiome said more than half the patients treated with Brinavess had a normal heart rhythm within 90 minutes, compared to about 5 percent of the amiodarone patients.

The companies said 51.7 percent of Brinavess patients had a normal heart rhythm within that time, and the median time to normal heart rhythm was 11 minutes. They said 5.2 percent of the patients who were treated with amiodarone met that goal. After 90 minutes, 53.4 percent of the Brinavess patients had no symptoms, compared to 32.8 percent of the amiodarone group.

Brinavess is an intravenous version of vernakalant, a drug Merck and Cardiome have been developing together. The companies have filed for approval in the U.S. and the European Union, and they are also working on an oral form of the drug. If approved, Brinavess would compete with Sanofi-Aventis' drug Multaq, which was approved in 2009.

A total of 232 patients were treated in the study, and Merck and Cardiome said the Brinavess patients also had a greater quality of life improvement based on a survey. The most common side effects of Brinavess were a bad taste in the mouth, coughing, sneezing, atrial fibrillation, nausea, dizziness, and high blood pressure.

Results from the trial were presented at a Heart Rhythm Society meeting in Denver.

0 التعليقات:

  ©Template by Dicas Blogger.