Merz Pharmaceuticals Announces Approval of Post-stroke Upper Limb Spasticity Indication for Xeomin(R) in the EU
FRANKFURT, Nov. 18 Today, Merz Pharmaceuticals announced XeominŽ, the first botulinum toxin type A free from complexing proteins has been granted an extension of indication for post-stroke spasticity of the upper limb presenting with flexed wrist and clenched fist in adults in various European countries. XeominŽ was already granted approval for post-stroke spasticity of the upper limb in early 2009 in Canada, Mexico and Argentina. This important extension of indication is based on the Kanovsky study, the largest randomized, placebo-controlled, double-blind trial with a botulinum toxin in upper limb post-stroke spasticity to date.
Data results published last month in Clinical Neuropharmacology, revealed that Merz Pharmaceuticals' NT 201 (botulinum toxin type A free from complexing proteins), also known by the brand name XeominŽ in Europe and Canada, was statistically significantly more efficacious than placebo for the treatment of patients with post-stroke upper limb spasticity. The Phase III study assessed the impact of NT 201 on muscle tone, functional disability and caregiver burden in patients with post-stroke upper limb spasticity, utilizing a randomized, placebo-controlled, double-blind design.
NT 201 is high in biologic activity and has a low protein load. It has been approved for marketing in Europe since 2005 to treat various movement disorders, and recently approved in Canada for the management of blepharospasm, cervical dystonia of a predominantly rotational form and post-stroke spasticity of the upper limb.
In the Phase III trial, a higher proportion of patients receiving NT 201 were responders in terms of improvement in the wrist flexors four weeks after treatment. Responders were defined as patients with at least 1 point of improvement in the Ashworth Scale Score.
Dr. Alexander Gebauer, Chief Scientific Officer, Head of Global R&D, Merz Pharmaceuticals, Frankfurt, Germany, said, "In addition to the impact it has on the day-to-day life activities, post-stroke spasticity can cause significant pain and discomfort to patients. The positive outcomes presented in this study suggest NT 201 may give promise to patients in search of a treatment option for post-stroke spasticity."
According to the National Stroke Association, 58 percent of stroke survivors experience post-stroke spasticity and only 51 percent of those are receiving treatment for that condition. Aside from pain and significant discomfort, post-stroke muscle spasticity can negatively impact mobility, ability to carry out personal hygiene, and other activities of daily living. In this study, significant improvements were shown in each of the four domains of the Disability Assessment Scale (DAS), including dressing, limb position, hygiene and pain, among patients treated with NT 201.
About Phase III Study
The Phase III study, conducted at 23 sites in Europe, included patients who, at least 6 months prior to enrollment, had experienced a stroke resulting in focal spasticity of the wrist and finger flexors (scores of greater than or equal to 2 on the Ashworth Scale). Participants were required also to have DAS scores of 2 or higher (at least moderate disability) in their chosen therapeutic target domain: dressing, limb position, hygiene or pain.
Medications to treat spasticity such as centrally-acting muscle relaxants and/or benzodiazepines and physical and occupational therapy regimens were permitted if they had been stable in the 2 weeks before screening, but no treatment changes were allowed during the study.
While treatment of the wrist and finger muscles was mandatory, other spastic upper limb muscle groups were treated as individually needed according to the investigator's clinical judgment. The maximum intended dose of study medication was 400 U. Follow-up was for up to 20 weeks.
In an intention-to-treat analysis among a total of 148 patients (NT 201=73; placebo=75), a larger proportion of NT 201 patients (mean 63.9%) were rated as responsive in each of five treatment muscle groups at week 4 as compared with patients receiving placebo (mean 35.72%). For the primary endpoint of wrist flexor treatment, the odds ratio (OR) of 3.97 favored NT 201 treatment significantly (95% confidence interval, 1.9-8.3; P <0.001). Significant ORs in favor of NT 201 ranging from 3.16 to 13.43 (P< 0.009) were observed for all other flexor muscle groups at week 4. Statistically significant results in favor of NT 201 were observed at all post-injection visits until week 12 in the principal therapeutic target (P less than or equal to 0.005), and in global assessment of efficacy by investigators, patients and caregivers (P < 0.001 for each). After 8 weeks of treatment, at least 50% of NT 201 patients were still responders in all muscle groups.
In Carer Burden Scale assessments (a measure of the impact on the physical care provider of hygiene and daily care tasks), significant advantages for NT201 were shown at week 4 in the tasks of putting the affected arm through a sleeve (p=0.021) and for cleaning the palm of the affected hand (p=0.028).
Adverse events, documented for 21 patients (28.8%) in the NT 201 group and in 20 patients (26.7%) in the placebo group were mostly mild in intensity. The majority (71%) of adverse events, including diarrhea, headache, hyperglycemia, contusion and hypercholesterolemia, resolved by the final visit.
About Post-stroke Spasticity
According to the National Stroke Association, 58 percent of stroke survivors experience post-stroke spasticity and only 51 percent of those are receiving treatment for that condition. Spasticity has been defined as a motor disorder characterized by a velocity-dependent increase in muscle tone with exaggerated tendon jerks, resulting from hyper excitability of the stretch reflex.
Merz Pharmaceuticals, LLC, a wholly owned, U.S. subsidiary of the Merz Group of Companies was established in 1995 and develops and commercializes prescription products for Neurology, Dermatology, Podiatry and the #1 non-prescription product for scars, Mederma.
With a 101 year heritage, Merz (KGaA) is known worldwide for its development of original compounds and formulations for medical professionals and consumers in 90 countries. Globally, Merz is a leader in the development of pharmaceuticals for the treatment of neurological and psychological disorders as well as for aesthetic medicine, including products for the treatment of wrinkles and aging skin, hair loss and acne. Research is concentrated in fields that have a strong need for therapeutic innovation such as Alzheimer's disease, Parkinson's disease, tinnitus, chronic pain conditions, addictions, and neuromuscular disturbances.
SOURCE Merz Pharmaceuticals
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