12/1/99 Worldwide Biotech (Pg. Unavail. Online)
1999 WL 26080007
Worldwide Biotech
Copyright 1999 Information Access Company. All rights reserved. COPYRIGHT 1999
Worldwide Videotex
Wednesday, December 1, 1999
Volume 11; Issue 12
ELAN'S NEW DRUG REDUCES SEVERITY OF CERVICAL DYSTONIA.
FULL TEXT
Elan Pharmaceuticals, Inc., South San Francisco, has announced the
results of two pivotal studies published in the journal Neurology which
could mean new hope for thousands of patients in the United States with
cervical dystonia (CD), a painful and disabling movement disorder. In
these studies, Elan's Botulinum Toxin Type B Injectable Solution,
evaluated under the name NeuroBloc(TM), was shown to reduce the pain,
severity and disability of CD. These studies were included in a Product
License Application, which was filed by Elan with the Food and Drug
Administration (FDA) in December 1998, and is currently under review.
Dystonia is the third most common movement disorder, causing painful
hyperactive contractions of muscle groups throughout the body. The most
prevalent form of the neurological condition is CD, which affects the
muscles of the neck and shoulders and can severely impact a patient's
quality of life. In the United States, an estimated 50,000 people have
CD and it affects approximately twice as many women as men.
Elan's Botulinum Toxin Type B Injectable Solution was evaluated in two
separate pivotal Phase 3 multi-center, double-blind clinical trials. The
first trial was limited to patients who were non-responders to botulinum
toxin type A. The second included patients who were thought to respond
to botulinum toxin type A. A statistically significant difference was
observed between patients receiving Elan's Botulinum Toxin Type B versus
placebo in reducing pain, severity and disability of CD. The trials also
demonstrated that in those patients responding to treatment, the median
duration of effect was 12 to 16 weeks. The most frequently reported
adverse events in these studies were dry mouth and dysphagia (difficulty
swallowing), which were generally mild to moderate, transient and self-resolving.
"Patients who no longer respond to botulinum toxin type A therapy are
particularly difficult to treat. In our study of this population, our
results showed Elan's Botulinum Toxin Type B provided relief of the
symptoms," said Mitchell F. Brin, MD, associate professor of Neurology,
director of the Movement Disorders Section at Mount Sinai Medical
Center, New York, and a principal investigator of the second study. "Our
findings show that this new botulinum toxin therapy potentially can help
CD patients regain control over this condition."
"This is one of the very first large multi-center trials to show a
statistically significant difference in patients with cervical dystonia
with an injection of botulinum toxin," said Allison Brashear, MD, an
assistant professor of Neurology at Indiana University School of
Medicine, and a principal investigator of one of the studies. "As a
potentially new therapeutic modality for overactive muscles, it shows
promise to broaden the armamentarium for physicians like myself to use."
"I think the results of the study are very encouraging for patients
with cervical dystonia," said Dr. Brashear. "Cervical dystonia is very
disabling and the pain and pulling and embarrassment can lead to
patients having a marked amount of disability." Adds Dr. Brashear, "My
patients with cervical dystonia follow the story very closely and are
anxious for another treatment."
Elan's Botulinum Toxin Type B is injected directly into the affected
muscles of patients and works by interrupting the transmissions between
the nerves and the muscles causing the affected muscle to relax. This
new botulinum toxin may provide patients with relief from the pain,
severity and disability of CD. If approved for marketing, this new toxin
will be supplied in a ready-to-use liquid formulation that requires no
reconstitution. It requires only normal refrigeration and is packaged in
three vial configurations of 2500, 5000 or 10,000 units, providing
maximum flexibility for physicians.
"The results of these important clinical trials demonstrate that Elan
is an innovator in the field of botulinum toxin therapy," said Paul
Goddard, president and CEO of Elan. "We are proud to be developing a
needed therapy that addresses a painful and debilitating condition
affecting thousands of people. Cervical dystonia is a very difficult
disease to study, so we are particularly encouraged by these positive findings. In fact, Elan has planned new clinical trials for other
neuromuscular conditions."
The studies were conducted by Elan Pharmaceuticals located in South
San Francisco. Elan Pharmaceuticals is a division of Elan Corporation,
plc. Elan Corporation, plc is a leading worldwide drug delivery and
biopharmaceutical company with its principal research and manufacturing
facilities in Ireland, the United States and Israel. Elan's shares trade
on the New York, London and Dublin Stock Exchanges.
For more information, call 800/537-8899.
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