12/2/99 Bus. Wire 17:39:00
Business Wire
Copyright (c) 1999, Business Wire
Thursday, December 2, 1999
Two Investigational Studies Published in Neurology Show Elan Pharmaceuticals'
Botulinum Toxin Type B Injectable Solution May Help Cervical Dystonia Patients
SO. SAN FRANCISCO--(BW HealthWire)--Dec. 2, 1999--
Results May Provide Hope for Sufferers
of Debilitating Movement Disorder
Elan Pharmaceuticals, Inc. ("Elan"), announced the results of two pivotal
investigational studies published in the October 22 issue of 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, was
evaluated for its ability 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 Phase 3 multi-center, randomized, double-blind, placebo-controlled
clinical trials. For both studies, the primary measurement of efficacy was the
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score from
baseline to Week 4. This measurement scale is composed of three subscales:
severity, disability, and pain. The secondary supportive measurement of
efficacy was the Patient Global Assessment at Week 4.
The first trial was limited to patients who were subjectively thought, in the
opinion of the investigator, to respond to previous injections of Botulinum
Toxin Type A but had lost their responsiveness. A total of 77 patients were
randomly assigned to receive either 10,000 U Botulinum Toxin Type B Injectable
Solution (n=39) or placebo (n=38). Patients were assessed at baseline and again
at weeks 2, 4, 8, 12, and 16. The mean improvements in TWSTRS total scores
between baseline and week 4 were 11.1 for 10,000 U vs. 2.0 for placebo. The
mean values for Patient Global Assessment of Change at Week 4 were 60.2 for
10,000 U and 39.5 for placebo, on a 100-mm scale.
The second trial included patients who subjectively appeared, in the opinion
of the investigator, to respond to Botulinum Toxin Type A. A total of 109
patients were randomly assigned to either receive Botulinum Toxin Type B
Injectable Solution (10,000 U (n=37), 5000 U (n=36)) or placebo (n=36).
Patients were assessed at baseline and again at weeks 2, 4, 8, 12, and 16. The
mean improvements in TWSTRS total scores between baseline and Week 4 were 11.7
for 10,000 U, 9.3 for 5000 U, and 4.3 for placebo. The mean values for Patient
Global Assessment of Change at Week 4 were 64.6 for 10,000 U, 60.6 for 5000 U,
and 43.6 for placebo, on a 100-mm scale.
Both 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 the first study were dry
mouth (17 of 39 patients receiving active drug vs. 1 of 38 patients receiving
placebo) and dysphagia or difficulty swallowing (11 of 39 patients receiving
active drug vs. 2 of 38 patients receiving placebo). Among patients in the
second study, the most frequently reported adverse events were dry mouth (9 of
37 patients receiving 10,000 U; 5 of 36 patients receiving 5000 U; and 1 of 36
patients receiving placebo) and dysphagia or difficulty swallowing (8 of 37
patients receiving 10,000 U; 4 of 36 patients receiving 5000 U; and 1 of 36
patients receiving placebo). The reported side effects in both studies were
generally mild to moderate, transient and self-resolving.
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 some 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 a
leader in the field of botulinum toxin therapy," said Paul Goddard, President
and Chief Executive Officer of Elan. "We are proud to be developing a 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.
CONTACT: Elan Pharmaceuticals David H. Mason, Jr., M.D., 800/537-
8899 17:24 EST DECEMBER 2, 1999
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