Clinical trials have been completed and Drug Master File has been filed to the Ministry of Health of the RF to introduce changes into the instruction for medical use: extending the age of application of the first Russian Botulinum toxin type A Relatox®. Upon registration, the drug will be approved for use in children with ICP for the indications of upper and lower limb muscle spasticity at the age of 2 to 13 years old. Earlier it was used in adults and children at the age of 13 to 17 years old for this indication. The clinical trial “Assessment of safety and efficiency of Relatox® in children with spastic forms of infantile cerebral paralysis at the age of 2-6 and 7-12 years old” was initiated in 2014. The developers of the drug hope that the extension of the age for the drug use will occur at the end of this or at the beginning of the next year already.
It is recognized that the average number of children suffering from this disease in the world is 1.7 to 7 per 1,000 healthy ones. The possibility to use this drug in young children is a rather expected event, since rehabilitation and treatment of children diagnosed with ICP and the duration of recovery process directly depends on the age; the earlier the treatment is initiated, the more efficient it is.
In Russia, Relatox® is the first and still the only BTA officially registered and approved for the treatment of upper limb and a wide number of lower limb muscle spasticity in children diagnosed with ICP at the age 13 to 18 years old. This is an essential advantage of the drug, since this allows specialists treating and rehabilitating children with ICP without violation of legislation and avoiding the risk related to BTA dose titration.
The drug developed by SPA Microgen JSC has been successfully used both in cosmetology, and for neurological indications: for mimic wrinkles correction, treatment of blepharism, upper limb muscle spasticity after a stroke, in hyperhidrosis. Relatox® is the first Russian Botulinum toxin-based medicinal product used in the treatment of spastic forms of infantile cerebral paralysis (ICP). In 2019, scientists of SPA Microgen started clinical trials of the toxin to expand the scope of its use in the treatment of cervical dystonia, chronic migraine, and urological conditions.