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Also known as Phase 2; Low Dose MYOBLOC, Phase 3; MYOBLOC
Myobloc · 3 trials · 7 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.
The first co-primary endpoint is the change from baseline in Modified Ashworth Scale (MAS) score for tone of the Primary Target Muscle Group (PTMG) selected for treatment at Week 4 post-injection. The MAS is an internationally accepted and validated instrument used to measure resistance during passive soft-tissue stretching. Resistance will be measured and recorded using a 6-point scale ranging from 0 (no increase in muscle tone) to 4 (affected part\[s\] rigid in flexion or extension). A lower change from baseline MAS score (\<0) represents a better outcome.
The second co-primary endpoint is the Clinical Global Impression of Change (CGI-C) score in functional ability at Week 4 post-injection. The CGI-C scale is a single item clinician assessment of how much the patient's functional ability has improved, worsened or has not changed relative to the patient's baseline state prior to treatment (injection). The CGI-C is rated on a 7-point Likert scale from 1 to 7, where 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". Successful therapy is indicated by a lower score (\<4) in subsequent testing.
| 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 |
| Phase 2; Low Dose MYOBLOC | EXPERIMENTAL | Low Dose MYOBLOC is a single treatment and will be compared to volume-matched placebo |
| Phase 2; High Dose MYOBLOC | EXPERIMENTAL | High Dose MYOBLOC is a single treatment and will be compared to volume-matched placebo |
| Phase 2; Placebo | PLACEBO_COMPARATOR | Volume-matched placebo is a single treatment |
| Phase 3; MYOBLOC | EXPERIMENTAL | MYOBLOC is a single treatment and will be compared to volume-matched placebo |
| Phase 3; Placebo | PLACEBO_COMPARATOR | Volume-matched placebo is a single treatment |
| 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 | - |
| Phase 2; Low Dose MYOBLOC | DRUG | Intramuscular injections on Day 1 |
| Phase 2; High Dose MYOBLOC | DRUG | Intramuscular injections on Day 1 |
| Phase 2; Placebo | DRUG | Intramuscular injections on Day 1 |
| Phase 3; MYOBLOC | DRUG | Intramuscular injections on Day 1 |
| Phase 3; Placebo | DRUG | Intramuscular injections on Day 1 |
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.