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Label indication MYOBLOC is an acetylcholine release inhibitor indicated for: Treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia in adults ( 1.1 ) Treatment of chronic sialorrhea in adults ( 1.2 ) 1.1 Cervical Dystonia MYOBLOC is indicated for the treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain associated with… FDA label
Also known as Botulinum Toxin Type B (Myobloc)
Botulinum Toxin Type B · 1 trial · 1 indication
9 point scale, 0 = no drooling, 9 = severe drooling
| Arm | Type | Description |
|---|---|---|
| Treatment 1 | EXPERIMENTAL | 1,500 Units (0.3 mL) MYOBLOC (0.3mL) with 500 Units (0.1 mL) injected into each parotid gland and 250 Units (0.05 mL) inject into each submandibular gland and will be compared to pooled placebo |
| Treatment 2 | EXPERIMENTAL | 2,500 Units of (0.5mL) MYOBLOC with 1,000 Units (0.2 mL) injected into each parotid gland and 250 Units (0.05mL) inject into each submandibular gland and will be compared to pooled placebo |
| Treatment 3 | EXPERIMENTAL | 3,500 Units of (0.7mL) MYOBLOC with 1,500 Units (0.3 mL) injected into each parotid gland and 250 Units (0.05mL) inject into each submandibular gland and will be compared to pooled placebo |
| Treatment 4 | PLACEBO_COMPARATOR | volume-matched placebo injected into each parotid gland and each submandibular gland |
| Name | Type | Description |
|---|---|---|
| Botulinum Toxin Type B (Myobloc) | BIOLOGICAL | - |
| Matched placebo to Myobloc | BIOLOGICAL | - |
Inclusion Criteria: * Parkinsons' Disease patients with Sialorrhea for at least 3 months Exclusion Criteria: * Patients with non-idiopathic PD parkinsonism * Patients previously exposed to botulinum toxins * Patients with a history of aspiration pneumonia, moderate/severe choking and/or moderate/...
Botulinum Toxin Type B is being studied for the treatment of drooling, also called sialorrhea, including in patients with Parkinson's disease. It is an investigational therapy in Phase 2 clinical development and is not approved for this use.
Botulinum Toxin Type B targets SNAP25, a protein involved in the release of neurotransmitters from nerve terminals. By acting on SNAP25, the drug is designed to reduce acetylcholine release and thereby decrease salivary gland secretion.
Botulinum Toxin Type B is being developed by Supernus Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker SUPN. The company is the sponsor of the clinical program evaluating the drug for drooling.
Botulinum Toxin Type B is in Phase 2 clinical development for drooling. It is an investigational product and has not been approved by the FDA for this indication.
Botulinum Toxin Type B has been evaluated in one completed Phase 2 trial, NCT00515437, titled A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients. The randomized, double-blind, placebo-controlled study enrolled 54 participants in the United States.
Yes, Botulinum Toxin Type B is also known as Myobloc. Myobloc is the brand name used for this botulinum toxin type B product in its clinical development for drooling.