Navigation Links
New Data On Xeomin® (IncobotulinumtoxinA) To Be Presented At The 15th International Congress Of Parkinson's Disease And Movement Disorders (MDS)
Date:6/8/2011

FRANKFURT, Germany, June 8, 2011 /PRNewswire/ -- Merz Pharmaceuticals today announced that new data on Xeomin® (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 chi-square test).

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).

About XEOMIN®

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®, the company has developed memantine (Axura®) -- 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.


'/>"/>
SOURCE Merz Pharmaceuticals
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Merz Pharmaceuticals Xeomin® (incobotulinumtoxinA) for the Treatment of Cervical Dystonia and Blepharospasm
2. Xeomin® (incobotulinumtoxinA) - a Botulinum Toxin Free From Accessory Proteins - Now Available in the U.S.
3. Xeomin® (incobotulinumtoxinA) Data To Be Presented At The 71st Annual Assembly Of The American Academy Of Physical Medicine And Rehabilitation
4. Merz Pharmaceuticals Introduces Comprehensive Programs to Provide Patients With Financial Assistance for Xeomin® (incobotulinumtoxinA)
5. Merz Pharmaceuticals Announces New Centers for Medicare and Medicaid Billing Q-Code for Xeomin® (incobotulinumtoxinA)
6. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
7. Pre-clinical Data on Recent Advances with HIV VLP Vaccine Presented at AIDS Vaccine 07 Conference
8. New Study Presented at WorldSleep 2007 Demonstrates Ramelteon Has Sustained Efficacy Over Six Months in Adults With Chronic Insomnia
9. Genasense(R) Data in Melanoma to be Presented in Opening Session at First Worldwide Melanoma Center Meeting of the European Association of Dermato-Oncology
10. Ozarelix Phase 2 Data Presented at 29th Congress of the Societe Internationale dUrologie
11. GeoVax Successful HIV/AIDS Vaccine Trial Data Presented at AIDS Vaccine 2007 Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/2/2016)... Leading Economies with Fastest Real GDP Annual Percentage Change, 2015  ... India 7.3, , Source: IMF and TechSci Research   ... Brazil , Russia , India ... registered the fastest GDP growth during the first decade of the 21 st ... Brazil and Russia , along with ...
(Date:5/2/2016)... 2016  Celsion Corporation (NASDAQ: CLSN ), ... from the first cohort of patients in its ... Study) combining GEN-1, the Company,s DNA-based immunotherapy, with ... newly-diagnosed patients with advanced ovarian cancer who will ... In the first three patients dosed, GEN-1 plus ...
(Date:4/29/2016)... India , April 29, 2016 ... Pipeline Review, H1 2016" market research report that ... complete with comparative analysis at various stages, therapeutics ... route of administration (RoA) and molecule type, along ... releases. It also reviews key players involved in ...
Breaking Medicine Technology:
(Date:5/4/2016)... ... May 04, 2016 , ... ... Nurses (WOCN) Society™ and Canadian Association for Enterostomal Therapy (CAET) will be ... saving and planning tools to attendees and exhibitors for the 2016 WOCN Society ...
(Date:5/4/2016)... ... 2016 , ... All-Star Insurance of Northeast TX has announced ... their local community. The agency pledges to select a new beneficiary every 60 ... bring awareness to important local causes with fundraising and other support, by forming ...
(Date:5/4/2016)... ... May 04, 2016 , ... Slepkow Slepkow & ... one of the top website design companies to create a state of the ... to the law firm's main practice areas. These practice areas include: real estate, ...
(Date:5/4/2016)... , ... May 04, 2016 , ... ... foundational nutrients that supports cellular and metabolic health. This synergistic combination of omega-3 ... free-form curcumin, along with 150 mg of reduced glutathione and 200 mg of ...
(Date:5/4/2016)... ... ... Natalie Jill is a well respected lifestyle mentor and fitness ... of her new book: Natalie Jill’s 7 Day Jump Start: Unprocess Your Diet . ... a new healthy lifestyle featuring simple recipes using MitoXcell’s raw cacao formula. , ...
Breaking Medicine News(10 mins):