The first botulinum toxin type-A free from complexing proteins has been approved for the treatment of spasticity in the EU.
Merz Pharmaceuticals’ Xeomin 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.
Xeomin is already approved for post-stroke spasticity of the upper limb in Canada, Mexico and Argentina.
The extension of indication is based on the Kanovsky study, the largest randomised trial with a botulinum toxin in upper limb post-stroke spasticity to date. Data results published last month in Clinical Neuropharmacology revealed that Xeomin was significantly more efficacious than placebo for the treatment of patients with post-stroke upper limb spasticity.
Dr Alexander Gebauer, Chief Scientific Officer, Head of Global R&D, Merz Pharmaceuticals, Frankfurt, 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% of stroke survivors experience post-stroke spasticity and only 51% 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.
Merz Pharmaceuticals was established in 1995 and is a leader in the development of pharmaceuticals for the treatment of neurological and psychological disorders.