Safety and efficacy of botulinum toxin type B for treatment of sialorrhea in Parkinson's disease: A prospective double-blind trial§

Authors


  • Funding agencies: Solstice Neurosciences, LLC.

  • Relevant conflicts of interest/financial disclosures: No publication committee was established prior to the study's initiation. Dr. Chinnapongse is an employee of US WorldMeds, LLC, the parent company of Solstice Neurosciences, LLC. Ms. Gullo is an employee and shareholder of US WorldMeds, LLC and Dr. Nemeth is a former employee of US WorldMeds, LLC. Dr. Zhang is an independent statistical consultant and Ms. Griggs is an independent medical writer, both compensated for their services by US WorldMeds, LLC.

  • §

    Full financial disclosures and author roles may be found in the online version of this article.

Abstract

Sialorrhea (drooling) is a common symptom of Parkinson's disease (PD) that can significantly impair a patient's health and quality of life. Fifty-four PD subjects with troublesome sialorrhea were enrolled using a multicenter, randomized, double-blind, sequential-dose escalation design in which subjects received a single intraglandular treatment with botulinum toxin type B (doses of 1,500 Units [0.3 mL]; 2,500 Units [0.5 ml]; or 3,500 Units [0.7 ml]) or placebo. Postinjection, subjects were followed acutely for 4 weeks and long-term for up to 20 weeks. Safety/tolerability, as assessed by adverse events, was the primary outcome measure. Efficacy, as assessed by the Drooling Frequency and Severity Scale and unstimulated salivary flow rate, was secondary. Gastrointestinal-related adverse events occurred more frequently in the active groups versus placebo group (31% vs 7%), with dry mouth being most common (15%). There were no serious adverse events attributed to botulinum toxin type B or discontinuations due to adverse events from treatment. At 4 weeks postinjection, Drooling Frequency and Severity Scale scores significantly improved versus placebo (−1.3 ± 1.3) in a dose-related manner (−2.1 ± 1.2, P = 0.0191; −3.3 ± 1.4, P < 0.0001; −3.5 ± 1.1, P < 0.0001, respectively) and unstimulated salivary flow rates significantly decreased in all active groups versus placebo (P ≤ 0.0009). Furthermore, treated subjects appeared to have more sustained improvement in sialorrhea than placebo subjects. We conclude that intraglandular injection of botulinum toxin type B was safe, tolerable, and efficacious in treating sialorrhea in PD patients. Additional studies are warranted to further confirm the drug's robust efficacy, as well as evaluate its effect with repeated dosing. © 2011 Movement Disorder Society

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