Cardiome, Astellas announce open-label study of atrial fibrillation drug

By E. Janene Geiss

Philadelphia, Oct. 19 - Cardiome Pharma Corp. and its co-development partner Astellas Pharma US announced Wednesday the initiation of an open-label safety study of intravenous RSD1235 for acute treatment of atrial fibrillation.

According to a company news release, the study, called ACT 4, will evaluate the safety of intravenous RSD1235 in approximately 120 atrial fibrillation patients.

RSD1235 is the intravenous formulation of an investigational drug being evaluated for the acute treatment of recent-onset atrial fibrillation.

There is no placebo or active control group in the study, which is being conducted by Astellas and carried out at approximately 30 centers in the United States, Canada and Europe, officials said.

ACT 4 is primarily a safety study and it is anticipated that the added safety data will supplement the pivotal ACT 1 and ACT 3 trial results, which showed promising efficacy and safety results, officials said.

"Our objective for this additional study is to ensure that we submit the most robust NDA possible within our stated timeline. With this study, we can enlarge our safety database and accomplish that goal efficiently," Bob Rieder, president and chief executive officer of Cardiome, said in the release.

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

Astellas, a U.S. subsidiary of Tokyo-based Astellas Pharma Inc., is a pharmaceutical company.

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