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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 rimabotulinumtoxinB, botulinum toxin type B
MYOBLOC · 3 trials · 2 indications
TEAEs Related to Study Medication include TEAEs classified as Possibly, Probably and Definitely Related. Treatment Session (TS)
Treatment Session (TS) AESI includes: Aspiration, Aspirational pneumonia, Choking and Dysphagia.
Participants Analyzed does not match the Participant Flow because one participant discontinued prior to the first post-injection visit. Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).
Treatment Session (TS)
Change weight of expectorated saliva at a Week 4 post-injection visit.
CGI-C was assessed on a 7-point scale ranging from "very much improved" to "very much worse" with 1 assigned to "very much improved" and 7 assigned to "very much worse"; ranging from a minimum score of 1 and a maximum score of 7.
9 point scale, 0 = no drooling, 9 = severe drooling
| Arm | Type | Description |
|---|---|---|
| MYOBLOC Injection | EXPERIMENTAL | After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections over the course of 1 year. |
| MYOBLOC 2500 U | ACTIVE_COMPARATOR | Subjects will receive specified dose of MYOBLOC |
| MYOBLOC 3500 U | ACTIVE_COMPARATOR | Subjects will receive specified dose of MYOBLOC |
| Placebo | PLACEBO_COMPARATOR | Subjects will receive volume matched Placebo |
| 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 |
|---|---|---|
| MYOBLOC | DRUG | After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments via injections into the submandibular and parotid glands. Subjects will undergo safety and effectiveness assessments at Weeks 4, 8, 13, 17, 26, 30, 39, 43, and 52, and telephone follow up will occur at Weeks 21, 34, and 47 |
| PLACEBO | OTHER | - |
| Botulinum Toxin Type B (Myobloc) | BIOLOGICAL | - |
| Matched placebo to Myobloc | BIOLOGICAL | - |
Inclusion Criteria: * Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring secondary to any disorder or related to any cause, including, but not limited to, Parkinson's Disease (PD), adult cerebral palsy, amyotrophic lateral sclerosis (ALS), stroke, traumatic brain i...
MYOBLOC is being developed for the treatment of troublesome sialorrhea, the excessive production and pooling of saliva, in adults. Supernus Pharmaceuticals is studying it in this neurology indication through Phase 3 clinical development. Sialorrhea is often associated with neurological conditions that impair swallowing and oral muscle control.
MYOBLOC is developed by Supernus Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker SUPN. The company is running the clinical program evaluating MYOBLOC in adults with troublesome sialorrhea.
MYOBLOC is in Phase 3 development for troublesome sialorrhea in adults. Two Phase 3 trials have been completed, and no active trials are currently listed. The program has enrolled a total of 374 participants across those completed studies.
Two completed Phase 3 trials have evaluated MYOBLOC in adults with troublesome sialorrhea. NCT01994109 was an efficacy and safety study followed by open-label multiple treatment, and NCT02610868 was an open-label, single-arm study. Both enrolled 187 participants and were conducted at sites including the United States, Russia, Ukraine, and Belarus.
The MYOBLOC Phase 3 program included randomized, double-blind, placebo-controlled designs, with one trial also featuring an open-label multiple-treatment extension. Participants were adults aged 18 years and older of any sex, and healthy volunteers were not enrolled. The two completed trials together enrolled 374 participants.