Two Investigational Studies Published in Neurology Show Elan Pharmaceuticals' Botulinum Toxin Type B Injectable Solution May Help Cervical Dystonia Patients.
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.
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|Date:||Dec 2, 1999|
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