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Abstract Details

RimabotulinumtoxinB (MYOBLOC) in the treatment of adult sialorrhea
Movement Disorders
P4 - Poster Session 4 (5:30 PM-6:30 PM)
10-024
To determine the efficacy, safety and tolerability of repeat injections of rimabotulinumtoxinB (MYOBLOC) for the treatment of sialorrhea.
Sialorrhea (drooling) can cause significant morbidity in several neurological disorders, including impaired oral hygiene, perioral irritation, embarrassment, swallowing impairment, and increased risk of aspiration. Local injections of botulinum toxin-B into the parotid and submandibular glands reduce saliva production.

This was a double-blind, placebo-controlled (DBPC) study with open-label (OL) extension (NCT01994109). In the DBPC phase, adult subjects with Parkinson’s disease, amyotrophic lateral sclerosis, medication induced drooling, stroke and other disorders were randomized (1:1:1) to receive rimabotulinumtoxinB 2500U vs 3500U vs placebo. During the OL phase, all subjects received 3500U of rimabotulinumtoxinB during the first OL treatment cycle; dose adjustments were permitted in OL cycles 2-4 (injection interval 11-15 weeks). Co-primary outcomes were change from baseline to week 4 in: Unstimulated Salivary Flow Rate (USFR) and Clinical Global Impression of Change (CGI-C).
Of the 187 enrolled subjects, 176 completed the DBPC, 170 entered OL treatment and 128 completed the OL phase up to 1 year. Treatment with rimabotulinumtoxinB in the DBPC study significantly reduced USFR week 4 versus placebo (mean treatment effect: -0.30 for both doses vs. placebo, p<0.0001). CGI-C scores were significantly better at week 4 for both treatment groups versus placebo (-1.21 for 2500U and -1.14 for 3500U, both p<0.0001). Treatment benefits were seen as early as week 1 and were maintained over repeat treatment for up to 1 year. The most frequent AE with rimabotulinumtoxinB was dry mouth (38-45%); in subjects who underwent repeat treatment, the incidence of AEs reduced over time.
RimabotulinumtoxinB provided effective treatment for sialorrhea in a DBPC multi-center trial. Long-term, repeat treatment with rimabotulinumtoxinB was effective in reducing sialorrhea in subjects for up to 1 year.
Authors/Disclosures
William Ondo, MD (Methodist Neurological Institute)
PRESENTER 		Dr. Ondo has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Neurocrine. Dr. Ondo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for ACADIA. Dr. Ondo has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Abbvie. Dr. Ondo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Kyowa Kirin. The institution of Dr. Ondo has received research support from Cerevel. The institution of Dr. Ondo has received research support from SCION. The institution of Dr. Ondo has received research support from Harmony. Dr. Ondo has received publishing royalties from a publication relating to health care.
Stuart H. Isaacson, MD, FAAN (Parkinson's Dis & Mov Dis Ctr of Boca Raton) The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sunovion. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for acorda. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for adamas. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neuroderm. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for amneal. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Neurocrine. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for adamas. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Supernus. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acadia. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie.
Mark F. Lew, MD, FAAN (USC School of Medicine) Dr. Lew has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Supernus. Dr. Lew has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for kyowa. Dr. Lew has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for neurocrine. Dr. Lew has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acorda. Dr. Lew has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acadia. Dr. Lew has received personal compensation in the range of $500-$4,999 for serving as a Consultant for RegenXBio. Dr. Lew has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Neurocrine. Dr. Lew has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Kyowa. Dr. Lew has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for acorda. The institution of Dr. Lew has received research support from MJFF. Dr. Lew has received research support from NIH.
Khashayar Dashtipour, MD, PhD Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine . Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for teva. Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for abbvie. Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for acadia. Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for kyowa kirin . Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for amneal . Dr. Dashtipour has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for neurocrine . Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for teva. Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for abbvie. Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for kyowa Kirin . Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for ipsen. Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for amneal . Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for acorda. The institution of Dr. Dashtipour has received research support from Abbvie. The institution of Dr. Dashtipour has received research support from ipsen. The institution of Dr. Dashtipour has received research support from amneal.
Dilip Chary No disclosure on file
No disclosure on file
Fernando L. Pagan, MD, FAAN (Georgetown University Hospital Dept of Neurology) Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acorda. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Adamas. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa Kirin. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sunovion. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for US World Meds. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Supernus. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Adamas. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amneal. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sunovion. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neurocrine. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sunovion. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Supernus. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Journal of Clinical Parkinsonism and related Disorders. Dr. Pagan has stock in Keiferx. The institution of Dr. Pagan has received research support from US World Meds. The institution of Dr. Pagan has received research support from Novartis.