Clinical use of non-a botulinum toxins: botulinum toxin type B

Since 1999, botulinum neurotoxin type B (BT, BT-B) has been used as NeuroBloc® / MyoBloc ™ for cervical dystonia, hyperhidrosis, spasticity, cerebral palsy, unilateral facial spasm, disorders used to treat bladder function, Snoring, anorectal escape, anal fissure, piriformis syndrome, various pain conditions and application to cosmetics. In general, its therapeutic effect is comparable to that of BT type A (BT-A). However, the adverse effects of BT - B and BT - A are greatly different. BT - B produces more localized and systemic anticholinergic side effects such as dry mouth, difficulty adjusting, conjunctival irritation, difficulty sweating, difficulty swallowing, heartburn, constipation, urinary difficulty of the bladder, and drying of the nasal mucosa Have been found. In BT - B, the relationship between autonomic nervous effects and motor effects known from BT - A is essentially shifted to the autonomic nerve effect. Therefore, careful use of BT-B is necessary in patients with autonomic neuropathy and patients with anticholinergic therapy.

When NeuroBloc® / MyoBloc ™ was used to treat patients with cervical dystonia who failed antibody-induced BT-A therapy, 86% of patients will experience complete secondary treatment failure after 5 applications. If NeuroBloc® / MyoBloc ™ is used for treatment of patients with cervical dystonia without prior exposure to BT, 44% will fail completely in the second treatment after nine enforcement. Therefore, NeuroBloc (R) / MyoBloc (TM) is associated with substantial antigenic problems derived from specific low specific biological efficacy. Systemic anticholinergic action and high antigenicity limits the clinical application of NeuroBloc® / MyoBlocTM

According to post-marketing reports, the effects of MYOBLOC (botulinum toxin type B) and all botulinum toxin products spread out from the injection site and may cause symptoms consistent with the effects of botulinum toxin. These include weakness, general muscle weakness, diplopia, blurred vision, difficulty swallowing, pronunciation difficulties, dysarthria, urinary incontinence, and breathing difficulties. These symptoms were reported from hours to weeks after injection. Dysphagia and dyspnea may be life-threatening, and there are reports of death. In children undergoing hearing impairment treatment, the risk of symptoms may be the highest, but treatment with people with delirium and other diseases, especially those with fundamental symptoms that are likely to cause these symptoms Symptoms also occur in adults.

One unit of MYOBLOC (botulinum toxin type b) corresponds to the calculated median lethal dose of intraperitoneal dose (LD 50) in mice. This assay was specifically performed for the production of MYOBLOC (botulinum toxin type B) by Solstice Neurosciences. Due to the details of various mouse LD50 assays (eg, vectors, dilution protocol, laboratory protocol), it is not possible to combine MYOBLOC's biologically active unit (botulinum toxin type B) with other botulinum toxins or other toxin units. Comparisons or transformations to units are assessed by other specific assays. Thus, the difference in species sensitivity to different botulinum neurotoxin serotypes eliminates dose-activity relationships in animals from human dose estimates. The specific activity of MYOBLOC (botulinum toxin type B) is in the range of 70 to 130 units / ng