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IncobotulinumtoxinA May Benefit Patients With Sialorrhea

Improvements in unstimulated salivary flow rate in both active treatment groups were sustained until week 16.


 

VANCOUVER—IncobotulinumtoxinA may help treat sialorrhea in patients with Parkinson’s disease or other neurologic conditions, according to a study presented at the 21st International Congress of Parkinson’s Disease and Movement Disorders.

“Results of this large controlled study confirm the efficacy and safety of incobotulinumtoxinA for the treatment of sialorrhea due to Parkinson’s disease and other etiologies,” said Andrew Blitzer, MD, DDS, an otolaryngologist at the Icahn School of Medicine at Mt. Sinai in New York City.

Andrew Blitzer, MD, DDS

Sialorrhea, or excessive drooling, is a disabling symptom of Parkinson’s disease, cerebral palsy, or other neurologic disorders. The prevalence of sialorrhea ranges from 32% to 74% in patients with Parkinson’s disease. This condition can cause social isolation and is associated with an increased risk of morbidity and mortality associated with perioral skin breakdown, aspiration pneumonia, choking, and dehydration. Previous studies have indicated that botulinum neurotoxin may be useful for treating sialorrhea. However, no formulations have been approved to treat this condition in adults.

To investigate the efficacy and safety of incobotulinumtoxinA for the treatment of sialorrhea, Dr. Blitzer and colleagues conducted a prospective, randomized, double-blind, placebo-controlled study at 33 sites (12 sites in Germany and 21 sites in Poland).

Eligible participants were adults with chronic sialorrhea related to Parkinson’s disease, atypical Parkinson syndromes, stroke, or traumatic brain injury. They had had sialorrhea for three or more months prior to screening. Patients that had non-neurologic secondary causes of sialorrhea were excluded.

Participants received either 75 U or 100 U of incobotulinumtoxinA or placebo. Dosing and injection sites were 15 U or 20 U into each submandibular gland and 22.5 U or 30 U into each parotid gland in the lower dose group and the higher dose group, respectively. Investigators followed subjects for approximately 16 weeks after injection. Primary outcomes included unstimulated salivary flow rate (USFR) at week 4, compared with baseline, and Global Impression of Change Scale (GICS) at week 4 post injection. Secondary outcomes included change in USFR from baseline to weeks 8 and 12, and GICS at weeks 1, 2, 8, and 12.

Among 184 participants included in the study, 54 were women, and the mean age was 65.2. Sialorrhea etiologies included Parkinson’s disease (70.6%), atypical Parkinson syndromes (8.7%), stroke (17.9%), and traumatic brain injury (2.7%). At baseline, the mean USFR was 0.40 g/min, and the mean Drooling Severity and Frequency Scale score was 6.86.

From baseline to four weeks post treatment, the mean change in USFR was 0.03 g/min in the placebo group, 0.07 g/min in the 75-U incobotulinumtoxinA group, and 0.12 g/min in the 100-U incobotulinumtoxinA group. In addition, secondary analyses indicated significant improvement in the USFR and GICS at week 8 and week 12 post injection in both active treatment groups. Researchers also found that improvement in the USFR was maintained in both dose groups at the last observation point at week 16.Overall, incobotulinumtoxinA was well tolerated. Eight patients withdrew from the study. Three participants discontinued treatment because of adverse events not related to treatment, and two because of a physician decision. One participant was lost to follow-up. The two most frequent treatment-related adverse events were dry mouth and dysphagia. No deaths were reported.

This study was sponsored by Merz Pharmaceuticals, which is headquartered in Raleigh, North Carolina.

Erica Tricarico

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