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Abstract Details

Efficacy results of a 12-month, dose-level blinded study of CVT-301 (levodopa inhalation powder) in patients with Parkinson’s disease
Movement Disorders
P2 - Poster Session 2 (5:30 PM-6:30 PM)
10-048
To present the efficacy results from a 12-month safety and efficacy extension of a phase 3 study of CVT-301, a levodopa inhalation powder in development for the treatment of OFF symptoms.

In the initial 12-week, double-blind, placebo-controlled study (SPAN-PD) of patients experiencing OFF periods, CVT-301 84mg significantly improved motor function, and, in addition, 57.7% of patients on CVT-301 84mg turned ON within 60 minutes after treatment vs 36.1% on placebo at 12 weeks. This abstract describes an extension study that investigates efficacy over 12 months.
Patients from the SPAN-PD study and eligible CVT-301-naïve patients were enrolled.  Patients maintained their usual oral carbidopa/levodopa regimen. All patients were on CVT-301 treatment for OFF periods, but were blinded to dose (60mg/84mg). Efficacy assessments included in-clinic assessment for occurrence of an ON state during the 60-minute postdose period, and, via a PD home diary, change in total daily OFF time and change in daily ON time without dyskinesia.
Patients were randomized: CVT-301 60mg (n=161) or CVT-301 84mg(n=164). At 12 months, during in-clinic evaluations, 68.4% of patients on CVT-301 60mg and 73.0% of those on 84mg achieved an ON state within 60 minutes of treatment. Percentages were not significantly different from 1-month values. Home diaries demonstrated that mean changes from baseline in total daily OFF time improved from 1-month values of –0.33 and –0.55 hours, to –0.70 and –0.88 hours at 12 months (60-mg and 84-mg doses, respectively). Change from baseline in daily ON time without dyskinesia improved from +0.23 and +0.18 hours at month 1 to +0.32 and +0.40 hours at month 12 (60mg and 84mg, respectively).
This extension study shows that CVT-301 maintained its efficacy in achieving an ON state in patients experiencing OFF periods, and showed improved efficacy in decreasing daily OFF time and increasing ON time without dyskinesia over 12 months.
Authors/Disclosures
Eric S. Farbman, MD, FAAN (Community Neurosciences Institute)
PRESENTER 		Dr. Farbman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus. Dr. Farbman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva. Dr. Farbman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acorda.
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.
Cheryl H. Waters, MD, FAAN (Columbia University) Dr. Waters has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acadia. Dr. Waters has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyowa. Dr. Waters has received personal compensation in the range of $500-$4,999 for serving as a Consultant for US world meds. Dr. Waters has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexza. Dr. Waters has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Acorda. Dr. Waters has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Acadia. Dr. Waters has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Neurocrine. Dr. Waters has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Bial. Dr. Waters has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for US world meds. Dr. Waters has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck. Dr. Waters has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Adamas. Dr. Waters has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sunovion. Dr. Waters has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amneal.
Robert A. Hauser, MD, MBA, FAAN (Movement Disorders Center) Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Supernus. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Stoparkinson. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Revance. Dr. Hauser has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Abbvie. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurocrine. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amneal. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Intrance. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zambon. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for NanoPharmasolutions. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HanAll BioPharma. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Cerevance. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Clario. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for ABLi Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sumitomo. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Taurus Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sorriddi Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Contera. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alterity Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Convatec Inc. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Knight Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biorasi. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medicure Pharma. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BlueRock. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Inhibikase. The institution of Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Stoparkinson. The institution of Dr. Hauser has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Photopharmics. The institution of Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ABLi Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal . Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurocrine Biosciences. Dr. Hauser has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Supernus. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie. Dr. Hauser has or had stock in Inhibikase.Dr. Hauser has or had stock in Axial Therapeutics.Dr. Hauser has or had stock in Enterin.Dr. Hauser has or had stock in Photopharmics. The institution of Dr. Hauser has received research support from Annovis Bio, Inc.. The institution of Dr. Hauser has received research support from Inhibikase Therapeutics. The institution of Dr. Hauser has received research support from AbbVie, Inc.. The institution of Dr. Hauser has received research support from Biogen MA. The institution of Dr. Hauser has received research support from Cavion, Inc.. The institution of Dr. Hauser has received research support from Cerevance Beta, Inc.. The institution of Dr. Hauser has received research support from Cerevel Therapeutics. The institution of Dr. Hauser has received research support from Enterin, Inc.. The institution of Dr. Hauser has received research support from Genentech. The institution of Dr. Hauser has received research support from Global Kinetics Corporation. The institution of Dr. Hauser has received research support from Hoffman-La Roche Inc. The institution of Dr. Hauser has received research support from Michael J. Fox Foundation for Parkinson's Research. The institution of Dr. Hauser has received research support from National Parkinson's Foundation. The institution of Dr. Hauser has received research support from Neuroderm. The institution of Dr. Hauser has received research support from Sage Therapeutics. The institution of Dr. Hauser has received research support from Scion NeuroStim. The institution of Dr. Hauser has received research support from UCB BioPharma. The institution of Dr. Hauser has received research support from UCB. The institution of Dr. Hauser has received research support from Amneal Pharmaceuticals. The institution of Dr. Hauser has received research support from Motric Bio, Inc.. The institution of Dr. Hauser has received research support from Sun Pharma Advanced Research Company. The institution of Dr. Hauser has received research support from Teva Branded Pharmaceuticals. The institution of Dr. Hauser has received research support from Truebinding, Inc.. The institution of Dr. Hauser has received research support from Jazz Pharmaceuticals. The institution of Dr. Hauser has received research support from Ipsen. Dr. Hauser has received intellectual property interests from a discovery or technology relating to health care.
No disclosure on file
Charles Oh, MD No disclosure on file