Comparative analysis of the effectiveness of Botulinum toxin type A — hemagglutinin preparations of the Relatox and Botox complex in the treatment of patients with primary idiopathic blepharospasm

Article

Author: Gusev, V.V. ; Lvova, O.A. ; Makarov, E.A.

Objective. To analyze the effectiveness of Relatox (Botulinum toxin type A — hemagglutinin complex) in comparison with Botox in the treatment of primary idiopathic blepharospasm. Material and methods. The study included clinical data for 21 patients with blepharospasm who were treated by botulinum therapy with Botox and Relatox for 3 years. The research method is a one-step retrospective analysis of medical data. Injections were carried out with a 3-month interval. On the 6th cycle, the drug was switched to Relatox. The clinical efficacy of the drugs was assessed using an 8-point Jankovich evaluation scale: the average values before the injection and 14 days after it were compared for each procedure. Results. Mean Jankovich scale scores decreased 2.5-fold for all cycles by the second week after the procedure (4.95 pre-injection vs. 1.8 post-injection), and the mean paired Student’s T-criterion for all injections was 7.14 (with a critical value of 2.021 and a significance level of p=0.05). The mean paired Student’s T-criterion for Botox was –6.63 and for Relatox –7.5 (with a critical value of 2.021 and a significance level of p=0.05), indicating a high efficacy of both drugs, slightly higher for Relatox. Conclusion. A consistent trend of increasing efficacy with regular botulinum toxin injections and greater efficacy of Relatox compared to Botox in the treatment of patients with primary idiopathic blepharospasm has been demonstrated.

01 Jan 2024·S.S. Korsakov Journal of Neurology and Psychiatry

Safety and efficacy of Relatox in comparison with Dysport in the treatment of focal spasticity of the upper limb in patients after stroke and traumatic brain injury (results of a prospective simple blind randomized comparative study in parallel groups)

Article

Author: Pogoreltseva, O A ; Korenko, A N ; Abramov, V G ; Zakharov, D V ; Novikov, S A ; Kostenko, E V ; Konovalova, Z N ; Orlova, O R ; Dudin, V A ; Yakovleva, P N ; Krasavina, D A ; Khatkova, S E

OBJECTIVEEvaluation of the safety and effectiveness of Relatox, botulinum toxin type A in patients with focal spasticity (FS) of the upper limb as a result of a cerebrovascular accident (CVA) or traumatic brain injury (TBI).MATERIAL AND METHODSA multicenter, prospective, single-blinded, randomized, comparative clinical study included 210 patients of both sexes aged 18-75 years after moderate to severe TBI and CVA in seven sites in the Russian Federation. The patients were randomized into two groups. Group 1 patients (n=105) with focal spasticity of the upper limb received Relatox injections into the muscles of the target pathological patterns (flexion of the elbow, hand, or fingers); Group 2 patients (n=105) received Dysport injections (reference agent). The drugs were injected with electromyographic (EMG) or ultrasound (US) control at a dose of no more than 400 Units of Relatox or 1000 Units of Dysport. Botulinum therapy was administered to patients for the first time or repeatedly, but not earlier than 3 months after CVA or TBI and 3 months (12 weeks) after the previous injection. At 4 and 12 weeks, spasticity was assessed using the Modified Ashworth Scale (MAS) for the muscles of the target spasticity pattern of the upper limb, the severity of disability was used to assess the Disability Assessment Scale (DAS), the severity of pain was evaluated using to the Numerical Pain Rating Scale (NPRS), and the satisfaction with treatment was measured by the Patient Global Impression of Improvement (PGI-I). The rate of adverse events (AEs) was reported.RESULTSA decrease in spasticity (decrease in MAS values) was shown in both groups without statistically significant intergroup differences at 4 weeks after injection for the muscles of the leading spasticity pattern of the upper limb (efficacy was assessed jointly for all target patterns) compared to the total score at the screening visit. The effect persisted for 12 weeks (more pronounced in the Relatox group). A significant decrease in pain severity according to the NPRS scale without significant intergroup differences was reported in both groups (slightly greater in Relatox group patients). The decrease in the mean DAS score with a statistically significant intergroup difference in hygiene, dressing, and overall well-being according to the PGI-I overall improvement scale was also greater in patients who received Relatox. Few local and systemic AEs were reported in both groups, with no intergroup differences. There were no significant deviations in laboratory parameters.CONCLUSIONThe results indicate the safety, good tolerability, and efficacy of Relatox in patients with focal spasticity of the upper limb after focal brain damage due to CVA or TBI, comparable and even slightly longer in duration than those of Dysport, which supports its widespread use in the rehabilitation.

01 Jan 2024·S.S. Korsakov Journal of Neurology and Psychiatry

Investigation of general toxic effects of Relatox in comparison with Dysport

Article

Author: Kurochkina, K G ; Koveshnikova, E I ; Novik, T S ; Chukina, S I

OBJECTIVETo evaluate the toxic effects of the agent Relatox on mature outbred rats and mice in an acute experiment in comparison with the registered analogue Dysport.MATERIAL AND METHODSBased on the aim of experiment, the acute toxic effects of Relatox and Dysport were assessed on two animal species: rats and mice at intraperitoneal and intramuscular administration at dose levels that made it possible to calculate the toxicological parameter values (initially 10-150 U/kg with subsequent usage of additional doses 20 U/kg to 300 U/kg depending on the agent and route of administration). The LD₅₀ values and other acute toxic parameters were calculated using probit analysis.RESULTSThe manifested intoxication picture was observed following administration of both agents, in which neurological symptoms specific to botulinum toxin came to the fore: muscle paresis and local paralysis, which were the result of the mode of therapeutic action of the toxin. The observed picture of intoxication, monitoring of the dynamics of body weight gains, as well as data of macroscopic analysis of organs and tissues indicate a complete analogy of animal responses to both agents administration. However, the mortality rates of animals differed when administered at different doses as well as the established LD₅₀ values of Relatox and Dysport.CONCLUSIONSBoth agents were more toxic when administered intraperitoneally than intramuscularly. Species or gender sensitivities were no detected for both agents. LD₅₀ values of Relatox and Dysport established based on the results of an acute experiment, should be considered taking into account the differences (approximately 2.5-3-folds) in the specific activity of these agents.

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Indication	Country/Location	Organization	Date
Muscle Spasticity	Russia	National Immunobiological Co. JSC	01 Jan 2014

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