* Drug backed for condition tied to excess water
* Reviewer recommends against use in heart failure patients
* Cornerstone shares up 5.4 pct
WASHINGTON, Sept 11 A clinical reviewer from the
U.S. Food and Drug Administration on Tuesday recommended the
agency approve Cornerstone Therapeutics Inc's drug to
treat low sodium levels due to a condition that causes the body
to have excess water.
However, the reviewer, Dr. Nancy Xu, said the drug
lixivaptan should not be approved for heart failure patients,
which Cornerstone had also sought.
Cornerstone shares were up 5.4 percent at $6.61 in morning
trading on Nasdaq.
The FDA staff review comes ahead of an advisory panel of
outside experts, which will vote on whether to recommend the
drug on Thursday. The FDA will make a final decision later,
taking into account the panel's recommendations.
Lixivaptan, from Cornerstone unit Cardiokine Inc, is meant
to treat low sodium levels in the blood, known as hyponatremia.
Although most people with the condition -- the most common
electrolyte disorder in the United States -- have no symptoms,
in severe cases it can cause swelling of the brain, respiratory
arrest and death.
The condition affects up to six million Americans, according
to the company, and is often tied to congestive heart failure.
Cornerstone had been seeking approval to use the drug in two
conditions that can cause low sodium levels: congestive heart
failure and syndrome of inappropriate antidiuretic hormone
secretion (SIADH), which causes the body to develop excess water
and is caused by improper chemical signals.
Xu recommended against the drug's use in heart failure
patients because it was linked to more deaths during a clinical
trial compared to placebo -- though it was uncertain whether the
drug actually caused the deaths.
"There is currently insufficient information about the drug
to determine whether the product is safe for use," she wrote in
documents posted online on Tuesday.
She also said the drug's side effects in SIADH, such as low
blood pressure, were not as great a concern.
Currently, low sodium levels tied to SIADH are treated with
tolvaptan, made by Japanese drugmaker Otsuka Holdings Co
, or by restricting how much water people drink, which
is difficult to do precisely, the FDA reviewer said.