MY EVIDENCE.
MY CHOICE.
MYOBLOC.
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Backed by clinical studies, MYOBLOC® is the first and only FDA-approved botulinum toxin B for the treatment of chronic sialorrhea in adults. See why physicians consider MYOBLOC for their patients.
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collapseSialorrhea can be a challenging symptom of Parkinson’s disease (PD)
![Icon](/sites/g/files/othskp1411/files/2023-06/Icon-80-Percent.png)
Affecting up to 80% of patients with PD, sialorrhea can be both underrecognized and undertreated.1,2
![Icon](/sites/g/files/othskp1411/files/2023-06/Icon-20-Percent.png)
Sialorrhea can cause life-threatening complications.*,3-5
Aspiration pneumonia carries ~20% mortality in patients with PD.6-8
Sialorrhea can affect patients by causing3,5,9-11:
![Icon](/sites/g/files/othskp1411/files/2023-06/Icon-Speech.png)
Speech disturbances
![Icon](/sites/g/files/othskp1411/files/2023-06/Icon-Sleep.png)
Sleep disruption
![Icon](/sites/g/files/othskp1411/files/2023-06/Icon-Social.png)
Social stigma
![Icon](/sites/g/files/othskp1411/files/2023-06/Icon-Caregiver.png)
Caregiver burden
![Icon](/sites/g/files/othskp1411/files/2023-06/Icon-Depression.png)
Depression
![Icon](/sites/g/files/othskp1411/files/2023-06/Icon-Skin-Infection.png)
Skin infection
*There are no studies showing that treating sialorrhea affects specific outcomes on this page.
“I’ll be reading...next thing I know, I’ve got drool all over the place. You’ll get a napkin or paper towel to wipe it off...in 15 minutes it may be the same thing again.”
George,† living with PD
“It was bad, it was really bad. I could follow him in the house…he was drooling all the way to wherever he was going. He didn’t even realize it.”
Margaret,† PD caregiver
![Icon](/sites/g/files/othskp1411/files/2023-06/Icon-Question-Mark.png)
Are your patients with PD aware that chronic sialorrhea is a separate and treatable condition?
†Actual patient and caregiver testimonials.
![](/sites/g/files/othskp1411/files/2023-06/Icon-Atom.png)
MYOBLOC has a distinct mechanism of action12
![Graphic showing the mechanism of action stages for MYOBLOC in chronic sialorrhea](/sites/g/files/othskp1411/files/2023-06/HCP-WhyCS-MOA-Mobile.jpg)
Stage 1: MYOBLOC binds to receptors on the neuronal surface via the heavy chain.
Stage 2: MYOBLOC enters the nerve cell via endocytosis and is contained in vesicles.
Stage 3: MYOBLOC light chain moves to the cytosol where it cleaves synaptic vesicle-associated membrane protein (VAMP)* essential for acetylcholine (ACh) release.
*VAMP is a component of the protein complex responsible for docking and fusion of the synaptic vesicle to the presynaptic membrane, a necessary step in neurotransmitter release.
For chronic sialorrhea, blocking ACh release from the neurosecretory cells of the salivary glands reduces saliva production.12
![Graphic showing the mechanism of action stages for MYOBLOC in chronic sialorrhea](/sites/g/files/othskp1411/files/2023-06/HCP-WhyCS-MOA-Desktop.jpg)
![Icon](/sites/g/files/othskp1411/files/2023-06/Icon-Checklist_0.png)
Proven clinical efficacy and tolerability for chronic sialorrhea
SELECT A DATA SET
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A phase 3, multicenter, randomized, double-blind, placebo-controlled, single-treatment efficacy and safety study
A phase 3, multicenter, randomized, double-blind, placebo-controlled, single-treatment efficacy and safety study
- 187 adult patients enrolled
- Objectives: Determine efficacy, safety, and tolerability over a 13-week period
- Unstimulated Salivary Flow Rate (uSFR) and Clinical Global Impression of Change* (CGI-C) at Week 4: Primary endpoints
- Patient Global Impression of Severity (PGI-S), Patient Global Impression of Change (PGI-C), Drooling Impact Score (DIS), Drooling Frequency and Severity Scale (DFSS): Secondary endpoints
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A phase 3, multicenter, randomized, double-blind, placebo-controlled, single-treatment efficacy and safety study
A phase 3, multicenter, randomized, double-blind, placebo-controlled, single-treatment efficacy and safety study
- 187 adult patients enrolled
- Objectives: Determine efficacy, safety, and tolerability over a 13-week period
- Unstimulated Salivary Flow Rate (uSFR) and Clinical Global Impression of Change* (CGI-C) at Week 4: Primary endpoints
- Patient Global Impression of Severity (PGI-S), Patient Global Impression of Change (PGI-C), Drooling Impact Score (DIS), Drooling Frequency and Severity Scale (DFSS): Secondary endpoints
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A phase 3, multicenter, randomized, double-blind, placebo-controlled, single-treatment efficacy and safety study
A phase 3, multicenter, randomized, double-blind, placebo-controlled, single-treatment efficacy and safety study
- 187 adult patients enrolled
- Objectives: Determine efficacy, safety, and tolerability over a 13-week period
- Unstimulated Salivary Flow Rate (uSFR) and Clinical Global Impression of Change* (CGI-C) at Week 4: Primary endpoints
- Patient Global Impression of Severity (PGI-S), Patient Global Impression of Change (PGI-C), Drooling Impact Score (DIS), Drooling Frequency and Severity Scale (DFSS): Secondary endpoints
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A phase 2, multicenter, double-blind, placebo-controlled, sequential dose-escalation study
A phase 2, multicenter, double-blind, placebo-controlled, sequential dose-escalation study
- 54 adult patients enrolled
- 4 dose arms: 1,500 Units (n=14); 2,500 Units (n=12); or 3,500 Units (n=13) vs. matching placebo (n=15)
- Patients were followed for up to 20 weeks after injection
- Primary outcome measures: Safety and tolerability
- All efficacy measures were considered secondary
- uSFR and CGI-C were measured at Week 4 and other selected time points
Significant improvement in uSFR was demonstrated at Week 4 for all doses tested11-13
At Week 4, MYOBLOC 2,500 U and 3,500 U achieved:
Early, significant, and enduring effect11-13
MYOBLOC treatment resulted in a significantly greater reduction in uSFR vs. placebo
![Chart showing comparing reductions in unstimulated salivary flow rate over 13 weeks for MYOBLOC and placebo](/modules/custom/myobloc_sscomponents/custom_components/clinical_study_cs1/clinical_study_cs1_graph_mobile.png)
![Chart showing comparing reductions in unstimulated salivary flow rate over 13 weeks for MYOBLOC and placebo](/modules/custom/myobloc_sscomponents/custom_components/clinical_study_cs1/clinical_study_cs1_graph_desktop.png)
- Reductions began at Week 1 and continued through Week 8 for both doses tested
- Significant effect continued through Week 13 for the 3,500 Unit dose
In the Phase 3, open-label extension (Study 1, Part B), improvement in uSFR was maintained for over 1 year with subsequent dosing of MYOBLOC 3,500 U.†
†Limitations associated with open-label study design, include lack of comparator arm, decreasing sample size and potential continued involvement of responders and attrition of nonresponders.
Significant improvement in CGI-C was demonstrated at Week 4 for all doses tested11-13
At Week 4, MYOBLOC 2,500 U and 3,500 U achieved:
![Graphic comparing improvements at week 4 of Clinical Global Impression of Change for MYOBLOC and placebo](/modules/custom/myobloc_sscomponents/custom_components/clinical_study_cs2/clinical_study_cs2_graph.png)
![Graphic comparing improvements at week 4 of Clinical Global Impression of Change for MYOBLOC and placebo](/modules/custom/myobloc_sscomponents/custom_components/clinical_study_cs2/clinical_study_cs2_graph_mobile.png)
*Chronic sialorrhea was "much improved" or "very much improved" according to CGI-C score at Week 4 post-injection in patients treated with MYOBLOC 2,500 Units (60%) and 3,500 Units (53%) compared to patients on placebo (12%).
In the Phase 3, open-label extension (Study 1, Part B), improvement in CGI-C was maintained for over 1 year with subsequent dosing of MYOBLOC 3,500 U.†
†Limitations associated with open-label study design, include lack of comparator arm, decreasing sample size and potential continued involvement of responders and attrition of nonresponders.
MYOBLOC has demonstrated tolerability11-13
Studies 1 and 2
Adverse reactions in at least 5% of MYOBLOC-treated patients and greater than placebo in pooled chronic sialorrhea studies
![Table showing adverse reactions in at least 5% of MYOBLOC-treated patients and greater than placebo in pooled chronic sialorrhea studies](/modules/custom/myobloc_sscomponents/custom_components/clinical_study_cs3/image-top.png)
*Adverse reactions for 1,500 Unit dose were only evaluated in Study 2.
†Adverse reactions for 2,500 Unit and 3.500 Unit doses were evaluated in Studies 1 and 2.
![Graphic showing the number of patients who discontinued due to dry mouth](/modules/custom/myobloc_sscomponents/custom_components/clinical_study_cs3/image-bottom-mobile.png)
![Graphic showing the number of patients who discontinued due to dry mouth](/modules/custom/myobloc_sscomponents/custom_components/clinical_study_cs3/image-bottom.png)
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Order MYOBLOC
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