Botulinum toxin type B

Overview

Neurotoxin produced by fermentation of clostridium botulinum type B. The protein 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.

Indication

For the treatment of patients with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.

Associated Conditions

Cervical Dystonia
Chronic Sialorrhea

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy and Safety Study of MYOBLOC® in the Treatment of Sialorrhea in Pediatric Subjects	2021/10/27	NCT05097079	Phase 3	Not yet recruiting	Supernus Pharmaceuticals, Inc.
Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa	2017/04/06	NCT03103074	Not Applicable	Completed	University Hospital of North Norway
Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adults	2015/11/20	NCT02610868	Phase 3	Completed	Supernus Pharmaceuticals, Inc.
Myobloc Atrophy Study	2014/01/31	NCT02052024	Phase 4	Completed	Georgetown University
Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects	2013/11/25	NCT01994109	Phase 3	Completed	Supernus Pharmaceuticals, Inc.
Pilot Study to Assess the Efficacy of Botulinum Toxin B on Pain and Disability in Subjects With Acute Low Back Pain	2006/10/06	NCT00384579	Phase 4	Terminated	United States Department of Defense
"DOES MYOBLOC™ IMPROVE FUNCTIONAL HAND USE IN YOUNG CHILDREN WITH A HYPERTONIC UPPER EXTREMITY?"	2005/10/13	NCT00238641	Phase 1	Completed	Stanford University
Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Dose-Response, Study of E2014 in Patients WIth Spasmodic Torticollis	2005/09/14	NCT00165776	Phase 2	Completed	Eisai Co., Ltd.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Myobloc	Solstice Neurosciences, LLC	10454-711	INTRAMUSCULAR	5000 [USP'U] in 1 mL	12/20/2023
Myobloc	Solstice Neurosciences, LLC	10454-710	INTRAMUSCULAR	2500 [USP'U] in 0.5 mL	12/20/2023
Myobloc	Solstice Neurosciences, LLC	10454-712	INTRAMUSCULAR	10000 [USP'U] in 2 mL	12/20/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MYOBLOC	solstice neurosciences, llc, a subsidiary of mdd us operations, llc	02252295	Solution - Intramuscular	5000 UNIT / ML	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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