Objective: To assess the safety, tolerability and effectiveness of repeated rimabotulinumtoxinB injections in adults with troublesome sialorrhea over a period of 1 year.

Background: Sialorrhea (drooling) is a common and troublesome feature of several neurological disorders, causing social embarrassment, perioral irritation, soiled clothing, swallowing impairment, and poor oral hygiene. Botulinum toxin type-B injections into the parotid and submandibular salivary glands reduce saliva production.

Method: This was a Phase 3, multicenter, open-label, outpatient study (NCT02610868). Subjects received rimabotulinumtoxinB (3500 U) on Day 1. Treatment was repeated when the subject returned to clinical baseline status (investigator judgment), with a treatment interval of 11-15 weeks. Dose reductions to 2500 U were permitted from cycle 2 for intolerability; subjects underwent scheduled dental exams.

Results: 187 subjects were enrolled. Etiologies treated included Parkinson’s disease (65.8%) and amylotrophic lateral sclerosis (13.9%). During the first treatment cycle, rimabotulinumtoxinBsignificantly reduced mean unstimulated salivary flow rate between baseline and Week 4 (reduction of -0.34±0.37 g/min, p <0.0001) and efficacy was maintained through Week 13 (p<0.0001).Clinical Global Impression of Change showed significant improvement from baseline to Week 4 post‑injection of every treatment cycle. Efficacy benefits were similar for treatment cycles 2-4. Most AEs were mild and well tolerated, only 5 subjects (2.7%) early discontinued due to an AE and <10% of subjects required a dose reduction for tolerability. Dry mouth was reported by the highest proportion of subjects in Session 1 (15.5%), followed by dental caries (7%). In Sessions 2 through 4, dental caries were reported by the highest proportion of subjects (8%-12%), followed by dry mouth (2-6%).

Conclusion: Long-term, repeat treatment with rimabotulinumtoxinBwas generally well-tolerated. The efficacy of repeat treatment was maintained for up to 1 year.

« Back to 2019 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/long-term-safety-and-efficacy-of-rimabotulinumtoxinb-in-the-treatment-of-adult-sialorrhea/