Navigation Links
FDA approves Merz Pharmaceuticals' Xeomin (incobotulinumtoxinA) for the treatment of cervical dystonia and blepharospasm
Date:8/2/2010

GREENSBORO, N.C., Aug. 2 - Merz Pharmaceuticals today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Xeomin (incobotulinumtoxinA), a botulinum toxin type A for the treatment of adults with cervical dystonia or blepharospasm. According to an epidemiology study conducted in Rochester, Minnesota, the prevalence of focal dystonia, which includes cervical dystonia and blepharospasm, is estimated at 295 per million people in the U.S.

"This is an important regulatory milestone for XEOMIN and is key to establishing our neurology business in the U.S.," said Jack Britts, President and CEO of Merz Pharmaceuticals, LLC. "We at Merz understand, and are committed to, addressing the complexities of treating and living with these neurological disorders."

The FDA approval of XEOMIN is based on the results of two pivotal U.S. clinical trials involving adult patients diagnosed with either cervical dystonia or blepharospasm. Additionally, active comparator studies conducted in Europe evaluating XEOMIN versus Botox (onabotulinumtoxinA) were included among the data submitted in support of the registration filing in these conditions.

XEOMIN is the only botulinum toxin that does not require refrigeration prior to reconstitution. Merz believes this may simplify product distribution and storage, and help ensure product integrity at the time of injection. XEOMIN will be available in 50-unit and 100-unit vials allowing dosing flexibility for administration.

About Dystonia

Dystonias are neurological movement disorders in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures. These movements, which are involuntary and sometimes painful, may affect a single muscle (focal), a group of muscles such as those in the arms, legs, or neck (segmental), or even the entire body (generalized). Symptoms can be mild or severe and dystonias may be markedly disabling.

Although dystonia is thought to be rare, it is possibly undiagnosed or misdiagnosed due to lack of specific clinical criteria. While focal dystonia, such as blepharospasm or cervical dystonia, can affect people at any age, most people first experience symptoms in middle age.

According to an epidemiology study conducted in Rochester, Minnesota, focal dystonia, which includes cervical dystonia, and may be characterized by twisting of the neck, and blepharospasm, or excessive eyelid spasm is estimated to affect 295 per million people in the U.S. Dystonias can be disabling, painful and often interfere with patients' daily activities.

About XEOMIN

In nature, Clostridium botulinum produces the toxin in association with ancillary complexing proteins. Manufacturers utilize this naturally occurring protein complex to produce therapeutic botulinum toxin products. Now Merz introduces XEOMIN (incobotulinumtoxinA) which employs a proprietary manufacturing process that isolates the therapeutic component and eliminates these ancillary complexing proteins. XEOMIN has been formulated to have high biologic activity with a low protein load.

XEOMIN is a botulinum toxin type A that is free from complexing proteins. It is FDA approved for the treatment of adults with cervical dystonia, to decrease the severity of abnormal head position and neck pain in both botulinum toxin-nave and previously treated patients and blepharospasm in adults previously treated with Botox (onabotulinumtoxinA). Please see important safety information below.

More than 84,000 patients have been treated with XEOMIN worldwide since 2005. The U.S. is the 20th country to approve XEOMIN for the treatment of cervical dystonia and blepharospasm.

Important Safety Information About XEOMIN

WARNING: Distant Spread of Toxin Effect

The effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms. See full prescribing information for complete boxed warning.

WARNINGS AND PRECAUTIONS

  • The potency Units of XEOMIN are not interchangeable with other preparations of botulinum toxin products. Therefore, units of biological activity of XEOMIN cannot be compared to or converted into units of any other botulinum toxin products.

  • Spread of toxin effects may cause swallowing and breathing difficulties that can lead to death. Immediate medical attention may be required in cases of respiratory, speech or swallowing difficulties. Use with caution in patients with compromised respiratory function or dysphagia. Concomitant neuromuscular disorders may exacerbate clinical effects of treatment.

  • Hypersensitivity reactions have been reported with botulinum toxin products (anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea). If serious and/or immediate hypersensitivity reactions occur, further injection of XEOMIN should be discontinued and appropriate medical therapy immediately instituted.

  • Cervical Dystonia: Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscles are at greater risk of dysphagia. Limiting the dose injected into the sternocleidomastoid muscle may decrease the occurrence of dysphagia.

  • Blepharospasm: Injection of XEOMIN into the orbicularis oculi muscle may lead to reduced blinking and corneal exposure with possible ulceration or perforation. Lower lid injections should not be repeated if diplopia occurred with previous botulinum toxin injections.

ADVERSE REACTIONS

Cervical Dystonia: The most commonly observed adverse reactions (≥5% of patients and > placebo) were: dysphagia, neck pain, muscle weakness, injection site pain, and musculoskeletal pain.

Blepharospasm: The most commonly observed adverse reactions (≥5% of patients and > placebo) were: eyelid ptosis, dry eye, dry mouth, diarrhea, headache, visual impairment, dyspnea, nasopharyngitis, and respiratory tract infection.


'/>"/>

Contact: Dawn Sciortino
DSciortino@rxmedyn.com
212-537-9495
Medical Dynamics
Source:Eurekalert

Related medicine news :

1. Early detection of cancer: The FDA approves procedure discovered by EPFL researchers
2. FDA approves first human neural stem cell clinical trial to treat brain tumors
3. FDA Approves Stemedica IND for Ischemic Stroke Clinical Trial
4. New York State Office of Mental Health Approves New High Performance Polycarbonate Sheet for Use in All Facilities
5. House of Representatives Approves Health-Care Reform Bill
6. Congress Approves Bill Curbing Internet Tobacco Sales in Victory for Kids and Taxpayers
7. New Jersey Approves Initiative to Expand the Number of Wound Care Certified Professionals
8. Golden Meditech Shareholders Approves of Name Change
9. The American Association of Anatomists approves guidelines for body donation programs
10. Kaiser Permanente Approves $170 Million in Community Benefit Grants in 2009
11. The malicious use of pharmaceuticals: An under-recognized form of child abuse
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/29/2016)... , ... April 29, 2016 , ... Regenerative Medicine ... Places to Work employee satisfaction survey, earning them second place for Tampa’s Best Places ... 25-49 employees. , “This is a great accomplishment for our team,” says RMS ...
(Date:4/29/2016)... ... April 29, 2016 , ... The infertility specialists at HRC ... Ghazal, and Dr. Daniel A. Potter -- are proud of the recent release of ... (SART). In April, SART published the latest verified data for 375 U.S. ...
(Date:4/29/2016)... , ... April 29, 2016 , ... ... to promote their animal line of probiotics, Petbiotics ™, as they fondly ... turnout of animal rescue groups networking for their non-profit organizations. Animal rescues across ...
(Date:4/29/2016)... MO (PRWEB) , ... April 29, 2016 , ... ... health and hospice software, outsourced billing and coding services, and Deyta Analytics, recently ... recognizes hospices providing the highest level of quality as measured from the caregiver’s ...
(Date:4/29/2016)... ... April 29, 2016 , ... Intellitec Solutions is ... of Microsoft Dynamics GP for one their long-term care clients. Working together with ... GP with key clinical management systems, and delivered a fully integrated accounting and ...
Breaking Medicine News(10 mins):
(Date:4/27/2016)... , April 27, 2016 Shire plc ... Jeff Poulton , Chief Financial Officer, will present at the ... Boston, MA on Wednesday, May 04, 2016, 10:00 ... will be available on the Presentations and Webcasts section of ... of the webcast will be available on this same website ...
(Date:4/27/2016)... , April 27, 2016 ... over USD 2.14 billion by 2022, according to ...      (Logo: http://photos.prnewswire.com/prnh/20150105/723757 ) ... advancement affecting the efficiency and accuracy delivered by ... persistent demand for novel urinalysis instruments and consumables. ...
(Date:4/26/2016)... , April 26, 2016 Diplomat Pharmacy, ... of Jennifer Hagerman , Pharm D., to Vice ... growing role at Diplomat, Hagerman will continue to lead ... company that delivers custom education and training to Diplomat ... specialty pharmacy industry. Diplomat University also houses the quality ...
Breaking Medicine Technology: