A New Botulinum Toxin Potentially Bioequivalent to OnabotulinumtoxinA: Are There Any Differences at All?

Yang, Gi-Hyeok; Jung, Hyun Ho

doi:10.1111/dsu.12073

Cited by 9 publications

(8 citation statements)

References 25 publications

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“…Because of their different properties, their comparability has been a subject of debate [ 10 ]. Neuronox (Medytox Inc, Ochang-eup, Cheongwon-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea), also known as Meditoxin in Korea, is a newly manufactured BoNT-A (Neu-BoNT/A) that was developed to provide features close to onabotulinum toxin A [ 11 ]. Neuronox was tested in a murine model, and its effect on muscle force generation was equivalent to BOTOX [ 12 ].…”

Section: Introductionmentioning

confidence: 99%

Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial

et al. 2015

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BackgroundBotulinum toxin type A is widely used for treating spasticity. Neuronox (Neu-BoNT/A), a newly manufactured botulinum toxin a, has not yet been investigated for its efficacy and safety in the treatment of post-stroke upper limb spasticity.ObjectiveWe evaluated the efficacy and safety of Neuronox (Neu-BoNT/A) compared with BOTOX (onabotulinum toxin A) for treating post-stroke upper limb spasticity.Methods In total, 196 stroke patients with moderate to severe upper limb spasticity were randomly assigned to either Neuronox or BOTOX intervention. The wrist flexors were mandatory and elbow, finger, and thumb flexors were optional muscles to be injected. Assessments were performed at baseline and 4, 8, and 12 weeks after the intervention. The primary outcome measure was the change from baseline of the Modified Ashworth Scale (MAS) at the wrist flexors at week 4. Secondary outcome measures included the change of MAS at each visit, response rate, Disability Assessment Scale (DAS), Carer Burden Scale, and Global Assessment of treatment benefit.Results Primary outcome measures were -1.39±0.79 and -1.56±0.81 in the Neuronox and BOTOX groups, respectively. The difference was within the noninferiority margin of 0.45 (95% upper limit=0.40). There were no significant differences between the groups in the secondary outcome and safety measures, except the change of the MAS at the elbow flexors at week 12 (-0.88±0.75 in the Neuronox group, -0.65±0.74 in the BOTOX group; P=0.0429). Both groups showed significant improvements in the MAS, DAS, and Carer Burden Scale at weeks 4, 8, and 12.Conclusion Neuronox showed equivalent efficacy and safety compared with BOTOX for treating post-stroke upper limb spasticity.Trial RegistrationClinicalTrials.gov NCT01313767

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Section: Introductionmentioning

confidence: 99%

Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial

et al. 2015

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“…The BoNT-A used in this study was Neuronox ® , also known in Korea as Meditoxin ® (Medytox Inc., Ochang-eup, Cheong-won-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea). Neuronox ® and Meditoxin ® are equivalent to BOTOX [ 32 ] and have been found to be safe with similar efficacy as has been proven in previous studies in children with CP [ 33 ] and in stroke patients [ 34 ]. Electromyography was used to record the hyperactivity of the muscle to be injected before starting the injection.…”

Section: Methodsmentioning

confidence: 89%

Botulinum Toxin Type A Injection for Cervical Dystonia in Adults with Dyskinetic Cerebral Palsy

Kim

et al. 2018

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We aimed to evaluate the efficacy and safety of injecting botulinum toxin A (BoNT-A) into the neck muscles to treat cervical dystonia (CD) in patients with dyskinetic cerebral palsy (CP). This was a randomized, double-blinded, placebo-controlled trial with cross-over design. We prospectively enrolled adults with dyskinetic CP who were over 20 years old and had been clinically diagnosed with CD for more than one year. The primary outcome measure was the change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) at four weeks from the baseline TWSTRS. Seventeen patients were initially enrolled, but one patient was excluded after the final evaluation because of a violation of the study protocol. At four weeks, the BoNT-A injections showed significant improvement in TWSTRS total scores compared to the saline injections (p = 0.0286 for ANCOVA). At 12 weeks, the BoNT-A injections resulted in greater improvements in TWSTRS total scores than the saline injections without statistical significance (p = 0.0783 for ANCOVA). Dysphagia occurred in three out of 16 patients: two after BoNT-A and one after saline. The dysphagia was transient and improved naturally within two weeks without any special treatment. BoNT-A injection for CD in adults with dyskinetic CP is relatively safe and improves pain and disability.

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“…The botulinum toxin type A and B [ 3 , 4 ] injections were equally effective and safe in adult CD patients, whereas side effects such as dry mouth and sore throat from BoNT-B were higher than from BoNT-A treatment [ 5 ]. Of those BoNTs, Ona-BoNT-A is the best known, dominating the botulinum toxin market since it was first approved and marketed in the United States in 1989, and Abo-BoNT-A has ranked second in the toxin market [ 6 ]. An alternative BoNT, Neu-BoNT-A, structurally similar to Ona-BoNT-A, could reduce the cost of treatment and be convenient in dosing and safety [ 6 ].…”

Section: Introductionmentioning

confidence: 99%

“…Of those BoNTs, Ona-BoNT-A is the best known, dominating the botulinum toxin market since it was first approved and marketed in the United States in 1989, and Abo-BoNT-A has ranked second in the toxin market [ 6 ]. An alternative BoNT, Neu-BoNT-A, structurally similar to Ona-BoNT-A, could reduce the cost of treatment and be convenient in dosing and safety [ 6 ]. The only difference between the two brands is that Ona-BoNT-A is a vacuum-dried preparation, whereas Neu-BoNT-A is freeze-dried [ 7 ].…”

Section: Introductionmentioning

confidence: 99%

Low-Dose Neubotulinum Toxin A versus Low-Dose Abobotulinum Toxin A Injection for the Treatment of Cervical Dystonia: A Multicenter, 48-Week, Prospective, Double-Blinded, Randomized Crossover Design Study

Kongsaengdao

Arayawithchanont

Samintharapanya

et al. 2021

Toxins

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Various types of botulinum toxin (BoNT) have been studied to treat cervical dystonia (CD). Although high-dose BoNT has proven efficacy, it increases the risk of adverse events. For this reason, this study was planned to identify the non-inferiority efficacy, tolerability, and safety of low-dose neubotulinum toxin A (Neu-BoNT-A) versus low-dose abobotulinum toxin A (Abo-BoNT-A) in CD treatment. The 48-week, prospective, randomized, controlled crossover design study of CD treatment, with 50-unit Neu-BoNT-A and 250-unit Abo-BoNT-A injections at 12-week intervals, was conducted over a 24-week treatment period. This study used the following standardized rating scales to assess the efficacy of BoNT: the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS); health-related quality of life (HRQoL); the Cervical Dystonia Impact Profile (CDIP-58); the Short Form 36 health survey questionnaire (SF-36); and, for the depressive symptoms of CD patients, the Center for Epidemiological Studies-Depression Scale (CES-D) and the Patient Health Questionnaire-9 (PHQ-9). Fifty-two CD patients were enrolled from October 2019 to January 2021. The mean scores of the TWSTRS total at the post-treatments in both Neu-BoNT-A and Abo-BoNT-A had a significant reduction from baseline (p = 0.008 and 0.002, respectively). However, the mean changes of the TWSTRS total at the 12- and 24-week treatments between the two treatment groups were not significantly different (p = 0.284 and 0.129, respectively). The mean scores of the HRQoL questionnaires (the CIDP-58 and the SF-36) and the depressive symptoms (the CES-D and the PHQ-9) in both treated groups at the post-treatments did not significantly decrease from baseline and were comparable. Two patients treated with Abo-BoNT-A (250 units) reported cervical tension and benign paroxysmal positional vertigo (BPPV). There were no serious adverse events reported. Though both low-dose BoNT-As were effective at improving clinical symptoms without significant side effects, both treatments did not predict change in quality of life and depression. With the non-inferiority criteria, low-dose Neu-BoNT-A has a similar efficacy, safety, and tolerability to Abo-BoNT-A.

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A New Botulinum Toxin Potentially Bioequivalent to OnabotulinumtoxinA: Are There Any Differences at All?

Cited by 9 publications

References 25 publications

Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial

Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial

Botulinum Toxin Type A Injection for Cervical Dystonia in Adults with Dyskinetic Cerebral Palsy

Low-Dose Neubotulinum Toxin A versus Low-Dose Abobotulinum Toxin A Injection for the Treatment of Cervical Dystonia: A Multicenter, 48-Week, Prospective, Double-Blinded, Randomized Crossover Design Study

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