New Data On Xeomin(R) (IncobotulinumtoxinA) To Be Presented At The 15th International Congress Of Parkinson's Disease And Movement Disorders (MDS)By Merz Pharmaceuticals, PRNE
Tuesday, June 7, 2011
FRANKFURT, Germany, June 8, 2011 -
- Data Show XEOMIN Improves Symptoms Of Cervical Dystonia And
Blepharospasm When Administered Across And Beyond The Standard Dosing Regimen
Merz Pharmaceuticals today announced that new data on Xeomin(R)
(incobotulinumtoxinA), a botulinum toxin type A free from accessory
(complexing) proteins, will be presented at the Movement Disorder Society's
(MDS) 15th International Congress of Parkinson's Disease and Movement
Disorders in Toronto, Canada. The studies found that repeated injections of
XEOMIN were safe and effective in the treatment of blepharospasm and cervical
dystonia (CD) when administered at flexible dosing regimens, including more
or less frequently than the standard dosing interval of 12 weeks.
Blepharospasm, also referred to as benign essential blepharospasm, and
CD, also known as spasmodic torticollis, are rare conditions that possibly go
undiagnosed or misdiagnosed. Botulinum toxin is the only FDA-approved
medication for the treatment of these conditions.
The first poster presented at the meeting, titled "IncobotulinumtoxinA
(NT-201) injections are safe and effective in adult subjects with
blepharospasm across dosing intervals in a repeated dose-study," concludes
that XEOMIN was safe and effective in the treatment of blepharospasm across
dosing regimens, including injection intervals of up to 10 weeks, 10 to 12
weeks and more than 14 weeks (the approved reinjection frequency is 12 weeks
or more). [Poster 609, June 8, 2011, 9 a.m. - 6 p.m.; Poster Presentation,
1:30 p.m. - 3 p.m.].
Additionally, the poster titled, "IncobotulinumtoxinA (NT-201) injections
are safe and effective in adult subjects with cervical dystonia across dosing
intervals in a repeated dose-study," concludes that XEOMIN was safe and
effective in the treatment of CD when administered according to a flexible
dosing regimen, including up to 10 weeks, 10 to 12 weeks and more than 14
weeks (the approved reinjection frequency is 12 weeks or more).[Poster 625,
June 8, 2011, 9 a.m. - 6 p.m.; Poster Presentation, 1:30 p.m. - 3 p.m.]
"These findings are supportive of a flexible dosing schedule for XEOMIN,
which can be determined according to individual needs," said Matthew Brodsky,
M.D., Director of the Neurotoxin Injection Program and Movement Disorders
Program at Oregon Health & Science University, Portland, Ore. "Cervical
dystonia and blepharospasm are variable chronic conditions that affect each
patient differently, so it's important that physicians work with their
patients to determine appropriate treatment regimens and dosing schedules on
a case by case basis."
In both studies, there were no significant differences in the overall
occurrence of treatment-emergent-adverse-events among groups (using
About The Studies
Patients with CD or blepharospasm who completed a placebo-controlled,
double-blind study (up to 20 weeks) evaluating the safety and efficacy of
XEOMIN, could enter an open label extension (OLEX) phase for blepharospasm
treatment or an extension phase (EP) for CD treatment.
Blepharospasm patients (n=102) who entered the OLEX phase were treated
with XEOMIN (up to 50 Units) for up to 69 weeks. Repeated injection intervals
were chosen at the discretion of the physician and patient, based on the
Jankovic Rating Scale (JRS) Severity subscore. In the subgroup analysis the
JRS Sumscore (Severity and Frequency Subscores) was the primary outcome
measure and all JRS Sumscores were significantly improved after each
injection (p<0.001) in each group (using paired t-test).
Cervical dystonia patients (n=214) who entered the EP were treated with
XEOMIN (111 in 240 Units group; 103 in 120 Units group) for up to 68 weeks.
Inter-injection intervals were chosen at the discretion of the physician and
patient, based on Toronto Western Spasmodic Rating Scale (TWSTRS) Total
score. In the subgroup analysis the primary efficacy outcome measure was
TWSTRS Total scores, which were significantly improved after each injection
(p<0.001) in each group (using paired t-test).
In nature, Clostridium botulinum produces the toxin in association with
accessory (complexing) proteins. Manufacturers isolate the therapeutically
active botulinum neurotoxin together with the accessory (complexing)
proteins. XEOMIN (incobotulinumtoxinA) is manufactured using a proprietary
process that isolates in an additional purification step the therapeutic
component and eliminates accessory proteins.
More than 127,000 patients have been treated with XEOMIN worldwide since
2005. XEOMIN is approved in 21 countries worldwide for the treatment of
cervical dystonia and blepharospasm and in 17 countries for the treatment
post stroke upper limb spasticity. It is currently not approved in the U.S.
for the treatment of spasticity.
XEOMIN is the only botulinum toxin product that does not require
refrigeration prior to reconstitution.
Merz Pharmaceuticals GmbH (www.merz.com):
Merz Pharmaceuticals, a member of the MerzPharma Group of companies, is
an innovative and international specialty healthcare company specializing in
the research, development and marketing of pharmaceuticals for the treatment
of neurological and psychiatric diseases. In addition to developing
XEOMIN(R), the company has developed memantine (Axura(R)) — the first drug
for the treatment of moderate to severe Alzheimer's disease. The company also
focuses on the development of innovative therapies within the therapeutic
areas of hepatology, metabolic disease and dermatology.
XEOMIN is a registered trademark of MerzPharma GmbH & Co KGaA.
Lauren Munroe at Medical Dynamics, +1-212-537-9495
Tags: canada, Frankfurt, Germany, June 8, Merz Pharmaceuticals