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Abstract Details

Onset of Action for RimabotulinumtoxinB in the Treatment of Adult Sialorrhea
Movement Disorders
P12 - Poster Session 12 (12:00 PM-1:00 PM)
3-006
To assess the onset of action for rimabotulinumtoxinB injections in the salivary glands for the treatment of sialorrhea.
Sialorrhea (drooling) causes significant morbidity including impaired oral hygiene, perioral irritation, embarrassment, swallowing impairment, and increased risk of aspiration. Local injections of botulinum toxin-B (BoNT-B) into the parotid and submandibular glands reduce saliva production. The onset of response is likely to be important in terms of patient and physician satisfaction with treatment. 
This was a double-blind, placebo-controlled study conducted over 13 ±2 weeks. Adult patients with Parkinson’s disease, amyotrophic lateral sclerosis, medication-induced, stroke and other disorders were randomized (1:1:1) to receive rimabotulinumtoxinB 2500U vs 3500U vs placebo. Onset of RimabotulinumtoxinB efficacy was defined as when the difference between the active dose vs placebo first became statistically significant (p <0.05) on the unstimulated salivary flow rate (USFR, co-primary outcome). Both clinicians and patients rated their global impressions of change (CGI-C, co-primary and PGI-C). 
USFR reductions were observed with both rimabotulinumtoxinB doses compared with placebo, beginning at Week 1 and continuing through Week 8 (p <0.0001). At Week 1, the treatment difference versus placebo was -0.13g/min [95% CI, -0.23, -0.04] in the 2500U group and -0.21g/min [-0.31, -0.11] in the 3500U group. By week 4, the treatment difference of -0.30 g/min [95% CI, -0.39, -0.21] was identical in both active arms. Compared to placebo, mean adjusted CGI-C scores also improved with rimabotulinumtoxinB beginning at Week 1 (2500U, p=0.0122; 3500U, p=0.0143) and continuing through Week 8 (p <0.0001 for both doses). For the 3500U dose, significance on PGI-C versus placebo was noted as early as Week 1.
RimabotulinumtoxinB provides a rapid onset of efficacy for patients suffering with troublesome sialorrhea related to many neurological disorders.
Authors/Disclosures
Laxman Bahroo, DO, FÂ鶹´«Ã½Ó³»­ (Medstar Georgetown University Hospital)
PRESENTER 		Dr. Bahroo has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Bahroo has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acorda. Dr. Bahroo has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine. Dr. Bahroo has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Supernus. Dr. Bahroo has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Bahroo has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Ipsen. Dr. Bahroo has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amneal. Dr. Bahroo has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia. Dr. Bahroo has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Revance. Dr. Bahroo has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Bahroo has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Abbvie. Dr. Bahroo has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Acorda. Dr. Bahroo has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Amneal. Dr. Bahroo has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Supernus. Dr. Bahroo has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Neurocrine. Dr. Bahroo has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sunovion. Dr. Bahroo has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Kyowa Kirin. Dr. Bahroo has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lundbeck. Dr. Bahroo has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Merz.
Stuart H. Isaacson, MD, FÂ鶹´«Ã½Ó³»­ (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.
Rajesh Pahwa, MD, FÂ鶹´«Ã½Ó³»­ (University of Kansas Medical Center) Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbott. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for ACADIA. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amneal. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Insightec. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jaaz. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Fasikl. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genetech. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Photopharmics. The institution of Dr. Pahwa has received research support from Abbott. The institution of Dr. Pahwa has received research support from Abbvie. The institution of Dr. Pahwa has received research support from Biogen. The institution of Dr. Pahwa has received research support from Parkinson Foundation. The institution of Dr. Pahwa has received research support from Roche. The institution of Dr. Pahwa has received research support from Sage. The institution of Dr. Pahwa has received research support from Sun Pharma. The institution of Dr. Pahwa has received research support from Theravance. The institution of Dr. Pahwa has received research support from Neuroderm. The institution of Dr. Pahwa has received research support from Ask Bio. The institution of Dr. Pahwa has received research support from Blue Rock. The institution of Dr. Pahwa has received research support from Cerevance. The institution of Dr. Pahwa has received research support from Fasikl. The institution of Dr. Pahwa has received research support from Scion. The institution of Dr. Pahwa has received research support from UCB. The institution of Dr. Pahwa has received research support from Ono. The institution of Dr. Pahwa has received research support from Intra-cellular Therapies. The institution of Dr. Pahwa has received research support from Ask Bio. The institution of Dr. Pahwa has received research support from Michael J Fox Foundation . The institution of Dr. Pahwa has received research support from Neuron 23. The institution of Dr. Pahwa has received research support from Roche.
No disclosure on file
Mark F. Lew, MD, FÂ鶹´«Ã½Ó³»­ (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.