Kos Pharmaceuticals Submits FDA Application for New Niaspan Form That Lowers Flushing Effect
CRANBURY, N.J. - Drug maker Kos Pharmaceuticals Inc. said Wednesday that it submitted a drug application to the Food and Drug Administration for a new form of its Niaspan cholesterol medication that cuts down on flushing, the drug's most common side effect.
In clinical trials, up to 88 percent of people taking Niaspan experienced flushing, characterized by redness, warmth, itching, or a tingling sensation that can occur on the face, neck, chest, and back.
The company said its new version, Niaspan CF, was shown to reduce the severity of flushing by 42 percent, and duration by 43 percent, when compared to regular Niaspan.
Niaspan is a proprietary formulation of extended-release niacin that raises levels of high density lipids, or "good" cholesterol.
Kos plans to launch Niaspan CF in the first quarter of 2007.
Shares of Kos rose 10 cents to $39.08 in afternoon trading on the Nasdaq.
CRANBURY, N.J. - Drug maker Kos Pharmaceuticals Inc. said Wednesday that it submitted a drug application to the Food and Drug Administration for a new form of its Niaspan cholesterol medication that cuts down on flushing, the drug's most common side effect.
In clinical trials, up to 88 percent of people taking Niaspan experienced flushing, characterized by redness, warmth, itching, or a tingling sensation that can occur on the face, neck, chest, and back.
The company said its new version, Niaspan CF, was shown to reduce the severity of flushing by 42 percent, and duration by 43 percent, when compared to regular Niaspan.
Niaspan is a proprietary formulation of extended-release niacin that raises levels of high density lipids, or "good" cholesterol.
Kos plans to launch Niaspan CF in the first quarter of 2007.
Shares of Kos rose 10 cents to $39.08 in afternoon trading on the Nasdaq.
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