- RimabotulinumtoxinB (RIMA) was safe and efficacious for alleviating sialorrhea associated with Parkinson’s disease, stroke, amyotrophic lateral sclerosis, and other disorders.
Why this matters
- Sialorrhea is associated with substantial morbidity, impaired QoL, social stigma.
- At 4 weeks, vs placebo, RIMA 2500 and 3500 U:
- Reduced unstimulated salivary flow rate (–0.30 g/minute; P<.001 and g p>
- Improved Clinical Global Impression of Change score (–1.21; P<.001 and p>
- Dry mouth (38.1%-45.3% vs 8.3%),
- Dysphagia (4.7%-11.1% vs 1.7%), and
- Dental caries (4.7%-7.9% vs 3.3%).
- A US, Ukrainian, Russian phase 3 randomized controlled trial among 187 adults with troublesome sialorrhea due to any disorder, cause (MYSTICOL trial):
- Unstimulated salivary flow rate ≥0.2 g/minute and
- Drooling Frequency and Severity Scale score ≥4.
- Randomization: double-blind RIMA 2500 U vs RIMA 3500 U vs placebo.
- Main outcomes: unstimulated salivary flow rate, Clinical Global Impression of Change.
- Funding: WorldMeds LLC.
- Fixed-dose design.
- Predominantly white study population.
- No active comparator.
- Long-term efficacy, safety, immunogenicity unknown.