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MYOBLOC is the only approved botulinum toxin for chronic sialorrhea in adults that can provide significant results in as early as 1 week.1,2
MECHANISM OF ACTION (MOA)
Blocks acetylcholine (ACh) release at the cholinergic neurosecretory junction of the salivary glands1
MYOBLOC cleaves synaptic vesicle-associated membrane protein (VAMP)*
- This blocking action reduces salivaproduction
- MYOBLOC has been hypothesized toshow a sensitivity to cholinergicautonomic neurons, especiallypostganglionic neurons containing M3receptors3,4
*VAMP is a component of the protein complex responsible for docking and fusion of the synaptic vesicle to the presynaptic membrane, a necessary step to neurotransmitter release.
What would symptom relief in as early as 1 week mean
to your patients and their caregivers?
PROVEN CLINICAL EFFICACY AND DEMONSTRATED TOLERABILITY
Click each to see specific data
CLINICAL STUDIES 1,5
Part A: Phase 3, multicenter, randomized, double-blind, placebo-controlled, single-treatment efficacy and safety study
- 187 patients enrolled
- Objectives: Determine efficacy, safety, and tolerability over a 13-week period
- Primary efficacy measures: Unstimulated Sailvary Flow Rate (USFR) and Clinical Global Impression of Change (CGI-C) at Week 4
Study 1: Part A Results
IMPROVEMENT AS EARLY AS 1 WEEK1,5
Study 1: Part A Results (cont’d)
MYOBLOC Treatment Resulted in a Significantly Greater Reduction in USFR vs. Placebo1,5
- 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
Study 1: Part A, Secondary Endpoints
2,500 Unit and 3,500 Unit doses significant on all scales at Week 45
Study 1: Part B
Phase 3, open-label, multiple-treatment extension study (N=170) to assess duration of efficacy, safety, and tolerability over a maximum of 65 weeks. Patients received up to 4 additional treatment sessions over 1 year5
Efficacy was maintained at subsequent
dosing of 3,500 Units for over 1 year5
Phase 2, multicenter, double-blind, placebo-controlled, sequential dose-escalation study
- 54 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
Study 2 Results:
Significant reduction in
USFR and CGI-C at Week
4 for all 3 MYOBLOC
dosage groups compared with placebo1,2
Studies 1 and 2:
Adverse reactions in at least
5% of MYOBLOC-treated
patients and greater than
placebo in pooled chronic
*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.
1 patient discontinued due to dry mouth
- The most common adverse reaction was dry mouth
- The majority of dry mouth adverse reactions were mild to moderate5
- The frequency of these common adverse reactions did not appear to be dose-dependent, except in the case of dry mouth
RATING SCALES AND MEASUREMENTS EXPLAINED1,2:
- Weigh empty collection cup
- Have patient clear any saliva in mouth
- Start 5-minute timer
- Instruct patient to allow saliva to pool in floor of mouth and expectorate into cup
- At 5 minutes, have patient expectorate any remaining saliva
- Weigh cup filled with saliva
USFR = (ending weight – starting weight) / 5 minutes
The blinded assessor (other than the physician who injects the study drug) will rate his/her impression of change in the patient's symptoms from the baseline (ie, pre-injection) of each treatment session to the time of assessment. The CGI-C is a 7-point scale ranging from a score of 1, “very much improved,” to a score of 7, “very much worse.”
PATIENT GLOBAL IMPRESSION OF SEVERITY (PGI-S):
The patient will rate his/her impression of change in severity of symptoms from the baseline (ie, pre-injection) of each treatment session to the time of assessment. The PGI-S is a 7-point scale ranging from a score of 1, “normal” to a score of 7, “among the most extremely ill.”
PATIENT GLOBAL IMPRESSION OF CHANGE (PGI-C):
The patient will rate his/her impression of change of symptoms from the baseline (ie, pre-injection) of each treatment session to the time of assessment. The PGI-C is a 7-point scale ranging from a score of 1, “very much improved” to a score of 7, “very much worse.”
DROOLING FREQUENCY AND SEVERITY SCALE (DFSS):
Performed by a blinded assessor.
Assessed on a 4-point scale ranging from 1 (never drools) to 4 (constantly drools).
Assessed on a 5-point scale ranging from 1 (dry, never drools) to 5 (profuse, clothing, hands, tray, objects become wet).
The DFSS total score ranges from 2 (dry and never drools) to 9 (profusely wet and constantly drooling).
DROOLING IMPACT SCALE (DIS):
A 10-item questionnaire with each item rated by the patient to evaluate the impact of sialorrhea on daily activities (eg, speech, social activities). For each question, the patient was requested to compare their current status to their last study visit using a 4-point scale ranging from 1 (not at all) to 4 (very much).
The DIS total score ranges from 10 (not at all impacted) to 40 (very much impacted).