Xyrem shows promising results:
Orphan Medical Narcolepsy Drug Shows Demonstrates Positive Benefits:
WESTPORT,
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.
According
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.
In addition,
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."
Orphan Medical
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."
The company
estimated that 125,000 people in the US are
narcoleptic,
with approximately 75,000 of these patients having cataplexy symptoms.
Shares in
Orphan Medical were down 5/8 at 6-3/4 in early
Wednesday
afternoon trade.