Approved for Use in Neurology
Botulinum Toxin RelatoxÒ manufactured by the Federal State Unitary Enterprise NPO Microgen, Russian Ministry of Health, is currently being introduced into the clinical practice. It is approved in neurology for treatment of upper limb muscle spasticity after ischaemic stroke.
It is of note, that Relatox is the first botulinum toxin manufactured in Russia, a strong rival to international analogues Botox and Disport. In 2012 it passed all required clinical trials, received certificates of quality and marketing authorization in Roszdravnadzor, and in 2014 it was released to the market.
The technology of RelatoxÒ is based on original technology of purification of natural botulinum toxin type A complex with hemagglutinin, enabling achievement of high purification grade: protein – 95%, nucleic acids – about 86%. It meets the WHO requirements.
Clinical trials in six large sites in Russia supported safety and efficacy of the drug. The drug is comparable to international similar drugs. It is affordable in terms of price, and available to a large number of adult patients.
Alexey Ershov, head of medicinal device authorization administration at NPO Microgen remarked that currently clinical trials of safety and efficacy in children with spastic forms of ICF and safety and efficacy in axillary hyperhidrosis are ongoing.
Therefore indications of RelatoxÒ are expanding.