The First Russian Botulinum Toxin is Approved for Use in Neurology

19.09.2016
Botulinum toxin Relatox® is now indicated for use in neurology for the treatment of the upper limb muscle spasticity after ischemic stroke. These changes were approved by the Ministry of Health of the Russian Federation and entered into force on September 19, 2016. Clinical trials were successfully passed in 6 largest research centers of the Russian Federation. According to the trial results, Relatox® proved its safety and effectiveness in the treatment of the upper limb muscle spasticity after ischemic stroke, similar to foreign analogues.

In Russia, this method has already been introduced into clinical practice in many institutions. Currently, four botulinum toxin type A drugs of several foreign manufacturers are authorized in the Russian Federation. “The development and introduction into clinical practice of the domestic botulinum toxin type A will make this method of treatment of spasticity accessible to the population of the Russian Federation,” said Aleksey Yershov, Head of the Registration and Medical Research Department of SPA Microgen. “At the moment, the company is conducting clinical trials on the safety and efficacy of the drug in children with spastic forms of cerebral palsy and in axillary hyperhidrosis. The work on the expansion of indications for Relatox® continues.”

The patented Relatox® technology is based on the original method of purification of the natural botulinum toxin type A complex with hemagglutinin, which makes it possible to obtain a drug with a protein purification degree of 95 % and about 86 % of nucleic acid purification degree, which meets the WHO requirements. In addition, specified culture medium allows to receive more purified product with high activity.

Spasticity is one of the leading symptoms that is mostly characteristic for such diseases as traumatic brain injury, multiple sclerosis, cerebral palsy, spinal injury, stroke, etc. Spasticity began to present a particularly serious problem due to a sharp increase in cerebrovascular pathology. In the Russian Federation, the number of patients with the history of stroke (or survived during the first month) reaches about 400,000 people annually, of which almost a third develop spasticity. The WHO data indicates that the prevalence of post-stroke spasticity is 0.2 %, that is 200 people per 100,000 inhabitants, all over the world (the MONICA Project, Stegmayr, 1997; www.wemove.org/spa).

No more than 20 % of survived patients completely recover after stroke. Most patients have the varying degrees of severity of neurological deficit, most often motor one. Recovery of impaired functions of the limbs, even partially, allows for the quicker social adaptation of such patients, but requires the doctor's experience, high qualifications and familiarity with the latest medical and diagnostic capabilities provided by brain science and high technologies. Among motor post-stroke disorders, spasticity — a symptom characterized, primarily, by an increase in muscle tone — is a serious problem.
Spasticity can exacerbate motor disorder and often aggravates in the first months after stroke. In the absence of treatment, this can lead to the development of contractures, limb deformities, pressure ulcers, pain, etc. Patients with spasticity are often not able to perform a lot of everyday activities, they become dependent on other family members and/or caregivers. They have reduced social activity, self-esteem, disrupted spatial representation of the body; they often experience pain, depression, etc. Maintaining such patients requires the development of evidence-based, long-term, comprehensive rehabilitation programs, taking into account the etiopathogenetic central and peripheral mechanisms.

High efficacy of botulinum toxin type A, confirmed by numerous studies, including multicenter, controlled studies, meta-analyzes, and approved by the relevant national associations (for example, the European Consensus 2009), is a great achievement in the treatment and rehabilitation of patients with post-stroke spasticity.