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Hyponatremia drug reaches phase III


A pharmaceutical company has announced its drug for congestive heart failure patients who suffer from hyponatremia is to go into phase III trials.

Biogen Idec said lixivaptan will go up against a placebo in around 650 patients in the US and Europe.

In previous clinical studies, people treated with the compound showed improvement in serum sodium concentrations, decreases in body weight, and increases in urine volume.

THE BALANCE (Treatment of HyponatrEmia BAsed on LixivAptan in NYHA Class III/IV Cardiac Patient Evaluation) study is a multi-centre, randomised, double-blind trial.

Dr Barry Ticho, vice president of cardiology at Biogen, said: “We are excited to see lixivaptan enter into phase III studies as it is Biogen Idec’s lead cardiology program.

“Lixivaptan has the potential to address significant unmet needs for heart failure patients as well as other clinical conditions associated with hyponatremia.”

Dr Cesare Orlandi, senior chief medical officer at Cardiokine, which is running the trial, added: “This multinational study utilises a novel design and addresses the needs of an important subset of the heart failure population.

“THE BALANCE study is the first of several planned trials for lixivaptan. We anticipate initiating pivotal studies in SIADH later this year.”

Biogen and Cardiokine expect to jointly develop lixivaptan, but Biogen will be responsible for its commercialisation, and Cardiokine will have an option for copromotion in the US.

Copyright © PA Business 2008

Biogen Idec

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