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MYOBLOC · 2 trials · 1 indication
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.
| 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 |
| 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 | - |
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 used for the treatment of troublesome sialorrhea, which is excessive drooling, in adult subjects. It is being developed by Supernus Pharmaceuticals, Inc. and is currently in Phase 3 clinical development for this indication.
MYOBLOC is being developed by Supernus Pharmaceuticals, Inc., a company traded on the stock exchange under the ticker symbol SUPN. The drug is currently in Phase 3 clinical trials for the treatment of sialorrhea in adults.
MYOBLOC is in Phase 3 clinical development. Two Phase 3 trials have been completed for the treatment of troublesome sialorrhea in adult subjects. The drug is investigational and has not been approved by regulatory authorities.
MYOBLOC has been studied in two completed Phase 3 clinical trials. The first trial, NCT01994109, enrolled 187 adults with sialorrhea and was conducted in the United States, Russia, and Ukraine. The second trial, NCT02610868, also enrolled 187 adults and took place in the United States, Belarus, and Ukraine.
MYOBLOC is a distinct drug being developed specifically for troublesome sialorrhea in adults. It is a small molecule administered in a placebo-controlled, double-blind, randomized trial setting. No alternative names for MYOBLOC have been reported.