Efficacy results of a 12-month, dose-level blinded study of CVT-301 (levodopa inhalation powder) in patients with Parkinson’s disease (P2.8-048)

Objective: 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. Background: 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. Design/Methods: Patients from the SPAN-PD study and eligible CVT-301-naive 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. Results: 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). Conclusions: 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. Disclosure: Dr. Farbman has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Dr. Farbman has received honoraria for advisory board participation from Teva Pharmaceuticals and UCB. Dr. Lew has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva, US World Meds, UCB, Lundbeck, AbbVie, Adamas Pharmaceuticals, Cynapsus, Revance, Acadia Pharmaceuticals, Neurocrine Biosciences, and Acorda Therapeutics. Dr. Lew has received research support from Parkinson’s Study Group, Michael J. Fox Foundation, Biotie, Neuroderm, Enterin Inc., Pharm2B Fellowship Grants, Allergan, and Medtronic. Dr. Waters has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sunovion, US WorldMeds, Acadia, Impax, Acadia, Lundbeck, Adamas, and US WorldMeds. Dr. Waters has received research support from Sanofi, Sunovion, and Roche. Dr. Hauser has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie Inc., Acorda Therapeutics, Academy for Continued Healthcare Learning, Acadia Pharmaceuticals, Inc., Adamas Pharmaceuticals, AstraZeneca, ApoPharma, Back Bay Life Science, Biotie Therapies, Bracket, Cerecor, Inc., ClearView Healthcare Partners, ClinicalMind Medical and Therapeutic Communications, CNS Ratings, LLC., Cowen and Company, Cynapsus Therapeutics, DDB Health LLC, Decision Resources Group (DRG), Eli Lilly & Company, eResearch Technology, Inc., Expert Connect, Extera Partners, GE Healthcare, Health Advances, HealthLogix, Health and Wellness Partners, Huron Consulting Group, Impax Laboratories, Impel Neuropharma, Intec Pharma Ltd., Jazz Pharmaceuticals, Kashiv Pharma LLC, Kyowa Kirin Pharmaceutical Development, Ltd., LCN Consulting, LifeMax, Life Sciences, Lundbeck LLC, The Lockwood Group, MEDACorp, Medscape, Medtronic, Michael J. Fox Foundation, Mitsubishi Tanabe Pharmaceuticals, Movement Disorder Society, National Institutes of Health (NIH), Neurocea LLC, Neurocrine Biosciences, Neuroderm, Neuropore Therapies, Orbes Medical Group, Outcomes Insights, Parkinson Study Group, Peerview Press, Pennside Partners, Pfizer, Inc., Pharma Two B, Ltd, Phase Five Communications, Prescott Medical Group, Prexton Therapeutics, Prilenia Development Ltd., Projects in Knowledge, Putnam Associates, Quintiles, RMEI Medical Education for Better Outcomes, SAI Med Partners LLC, Sarepta Therapeutics, Schlesinger Associates, Scion Neurostim, LLC, Seagrove Partners, LLC, Slingshot Insights, Sunovion Pharmaceuticals, Inc., Sun Pharma, Teva Pharmaceutical Industries, US WorldMeds, Vista Research, WebMD, Windrose Consulting Group. Dr. Hauser has received royalty, license fees, or contractual rights payments from the University of South Florida. Dr. Hauser has received research support from AbbVie Inc., Acorda Therapeutics, AstraZeneca, Axovant Sciences , Biogen Inc., Cavion, Enterin Inc., Impax Laboratories, LLC., Intec Pharma Ltd, Jazz Pharmaceuticals, NeuroDerm Ltd., Lundbeck, Michael J Fox Foundation for Parkinson’s Research, F. Hoffman-La Roche, Dart NeuroScience LLC, Prexton Therapeutics, Revance Therapeutics Inc., Sunovion Pharmaceuticals. Dr. Klingler has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Acorda Therapeutics, Inc.. Dr. Oh has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Acorda Therapeutics, Inc. Dr. Oh is an employee and stockholder of Acorda Therapeutics, Inc.