Xyrem shows promising results:
Orphan Medical Narcolepsy Drug Shows Demonstrates Positive Benefits:
Jan 20 (Reuters Health) - Orphan Medical said on
Wednesday that its sodium oxybate (Xyrem) oral solution showed measurable benefits in treatment of two primary symptoms of narcolepsy in two separate studies.
to the Minneapolis, Minnesota-based firm, a 68.6%
reduction in the median number of cataplexy attacks was seen in patients who received 9.0 g of Xyrem compared with baseline. Orphan Medical said this improvement was "highly statistically significant" compared with placebo.
patients who received the drug experienced a
reduction in excessive daytime sleepiness, as measured by the Epworth Sleep Scale, the company reported. Some of the patients "...experienced reductions to the point of normal sleepiness."
intends to initiate a Phase IIIb, 18-month
controlled trial early this year to validate the results using additional measures of daytime sleepiness. According to the company, the US Food and Drug Administration has indicated that the additional study might permit additional labeling claims but does not need to be included in its Xyrem New Drug Application submission.
Orphan Medical CEO John H. Bullion said, "We expect to submit a New Drug Application to the Food and Drug Administration later this year. Since the FDA has already indicated that Xyrem qualifies for priority review status, we hope to obtain FDA approval to begin marketing Xyrem during the first half of 2001."
estimated that 125,000 people in the US are
narcoleptic, with approximately 75,000 of these patients having cataplexy symptoms.
Orphan Medical were down 5/8 at 6-3/4 in early
Wednesday afternoon trade.
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