By: Ed Susman
TORONTO, ONTARIO, CANADA – The new compound NT 201 (botulinum neurotoxin free from complexing proteins) appears to improve treatment of blepharospasm and cervical dystonia by at least 25%, researchers stated at the 62nd Annual Meeting of the American Academy of Neurology.
“The efficacy of NT 201 has been consistently demonstrated across several controlled clinical studies of patients with focal dystonia,” said Michael Marx, MD, Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany, speaking at several poster presentations.
In a pooled analysis of 4 studies — 2 on blepharospasm (n = 414) and 2 on cervical dystonia (n = 691) — Dr. Marx said that patients achieved a mean symptomatic improvement of approximately 25% over placebo, and more than half of patients reported at least moderate symptomatic improvement.
Dr. Marx tested 2 different injected doses of NT 201 against either placebo or botulinum toxin type A. In the placebo-controlled studies, the patient-evaluated global response to NT 201 was significantly superior to placebo (P < .001). Overall 53.4% of patients on NT 201 reported moderate, marked, or complete symptomatic improvement compared with 12% of placebo patients.
"Dystonia may affect any part of the body, including the arms, legs, trunk, neck, head, or face," Dr. Marx explained. "In focal dystonia, a single body region is affected. Cervical dystonia is characterised by involuntary contractions of the throat and neck; blepharospasm is characterised by involuntary contractions of the orbicularis oculi muscle of the eye."
Botulinum toxin has been shown to relax muscles and to be an effective treatment for dystonia. In studies that compared NT 201 with botulinum toxin type A, Dr. Marx noted, the investigative drug achieved at least noninferiority with the substance already in the marketplace.
NT 201 differs from other botulinum products in that the new compound is free from complexing proteins that could cause the creation of neutralising antibodies.
NT 201 is currently available in Argentina, Canada, Mexico, and 13 European nations.
Funding for this study was provided by Merz Pharmaceuticals.
- MFP Wire Services