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Myobloc (Rimabotulinumtoxinb) - Summary

 
 



Distant Spread of Toxin Effect

Postmarketing reports indicate that the effects of MYOBLOC and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses.

 

MYOBLOC SUMMARY

Myobloc® (rimabotulinumtoxinB) injection is a sterile liquid formulation of a purified neurotoxin that acts at the neuromuscular junction to produce flaccid paralysis. The neurotoxin is produced by fermentation of the bacterium Clostridium botulinum type B (Bean strain) and exists in noncovalent association with hemagglutinin and nonhemagglutinin proteins as a neurotoxin complex. The neurotoxin complex is recovered from the fermentation process and purified through a series of precipitation and chromatography steps.

MYOBLOC is indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.


See all Myobloc indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Myobloc (Rimabotulinumtoxinb)

[A double-blind comparative study to evaluate the efficacy and safety of NerBloc® (rimabotulinumtoxinB) administered in a single dose to patients with cervical dystonia]. [Article in Japanese] [2013]
We conducted a single-dose, placebo-controlled, double-blind, dose-response study of NerBloc®(rimabotulinumtoxinB) in patients with cervical dystonia (placebo, 2,500 U, 5,000 U, 10,000 U). The primary endpoint, the change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-total score at 4 weeks post dose from baseline, showed a significant improvement in all treatment groups (2,500 U, 5,000 U, 10,000 U) compared with the placebo group...

RimabotulinumtoxinB effects on pain associated with cervical dystonia: results of placebo and comparator-controlled studies. [2010]
Response rate (RR) and mean improvement (MI) in the pain subscale of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS-PS) from two placebo-controlled studies and one comparator-controlled study were evaluated to examine the effect of rimabotulinumtoxinB (BoNT-B) on cervical dystonia (CD) pain...

Pilot study of the safety and efficacy of Myobloc (botulinum toxin type B) for treatment of axillary hyperhidrosis. [2005]
(botulinum toxin type B) in the treatment of bilateral axillary hyperhidrosis... CONCLUSION: Myobloc (botulinum toxin type B) proved to be safe and efficacious

Double-blind, randomized, placebo-controlled pilot study of the safety and efficacy of Myobloc (botulinum toxin type B) for the treatment of palmar hyperhidrosis. [2005]
placebo-controlled study to report on the safety and efficacy of Myobloc... CONCLUSION: Myobloc proved to be efficacious for the treatment of palmar

RimabotulinumtoxinB versus OnabotulinumtoxinA in the treatment of masseter hypertrophy: a 24-week double-blind randomized split-face study. [2013]
OnabotulinumtoxinA (BTX-A) in the treatment of masseter hypertrophy... CONCLUSION: Both BTX-A and BTX-B are effective in the treatment of masseter

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Clinical Trials Related to Myobloc (Rimabotulinumtoxinb)

Myobloc Atrophy Study [Active, not recruiting]
The present pilot study is designed to assess the extent to which BOTOX and MYOBLOC cause muscle atrophy in spastic patients. The primary objective is to assess whether there is statistically significant difference in muscle atrophy between the two groups over a one year period.

Efficacy and Safety Study of MYOBLOC� Followed by Open-Label Multiple-Treatment With MYOBLOC� in the Treatment of Troublesome Sialorrhea in Adult Subjects [Recruiting]
This study will evaluate the efficacy and safety of MYOBLOC in the treatment of Sialorrhea (drooling), which can be a symptom of many disease conditions. MYOBLOC will be injected directly into the salivary glands. MYOBLOC has been shown in previous trials to safely decrease saliva production, thereby demonstrating its potential as a safe and effective treatment for troublesome sialorrhea.

An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia [Completed]
Five hundred patients with a confirmed clinical diagnosis of Cervical Dystonia (CD)are planned for enrollment into this open label study. These patients will be Type B toxin naive patients with CD. During this study patients will receive repeat injections of MYOBLOC when deemed appropriate by the Investigator. However, it will be recommended that injections occur not more frequently than every 12 weeks. Total duration of exposure to MYOBLOC will be targeted for at least two years, with potential exposure for up to 7 years in patients with earliest enrollment

Study of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS) [Completed]
The purpose of this study is to determine the safety and efficacy of Myobloc in ALS patients who are having excessive drooling. The primary goal of the study is to determine if the patient perceives a benefit from the Myobloc in controlling excessive drooling.

A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients [Completed]

more trials >>


Page last updated: 2014-12-01

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