Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 used for drooling, also known as sialorrhea. It is being investigated as a treatment for drooling in patients with Parkinson's disease. The drug is currently in Phase 2 clinical development and is not yet approved by the FDA.
Botulinum Toxin Type B is being developed by Supernus Pharmaceuticals, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol SUPN on the NASDAQ exchange.
Botulinum Toxin Type B is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied for the treatment of drooling, specifically in patients with Parkinson's disease.
Botulinum Toxin Type B has one completed clinical trial, identified as NCT00515437. This was a Phase 2, randomized, double-blind, placebo-controlled study that enrolled 54 participants. The trial was conducted in the United States and evaluated the drug for the treatment of sialorrhea in Parkinson's disease patients.
Yes, Botulinum Toxin Type B is the same as MYOBLOC. The clinical trial NCT00515437, which studied the drug for drooling in Parkinson's disease patients, is titled 'A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients.'