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Abstract Details

P2B001 (low dose combination of extended-release pramipexole and rasagiline) versus titrated extended-release pramipexole in the management of early Parkinson’s disease: Exploratory findings from a randomized, controlled trial
Movement Disorders
S32 - Movement Disorders: Trials (5:18 PM-5:30 PM)
010

P2B001 is an investigational, fixed low-dose, once-daily combination of ER formulations of pramipexole and rasagiline (0.6/0.75mg). We have previously reported that P2B001 provided significantly superior symptomatic efficacy compared to each of its components (primary efficacy endpoint). Here we report exploratory findings of P2B001 versus Prami-ER which was titrated for optimal efficacy and tolerability. 

Evaluate the efficacy and safety of P2B001 compared with Extended-Release pramipexole (Prami-ER) in untreated Parkinson’s disease (PD).

This was an international, multicenter, randomized, double-blind, parallel-group study in patients with early untreated PD comparing once-daily P2B001 to its individual components and to optimally titrated Prami-ER (mean dose of 3.2mg). Eligible patients were aged 35–80y, <3 years from PD diagnosis, and not receiving anti-parkinsonian therapy.  Exploratory endpoints are presented along with nominal p-values.

Changes from baseline to week 12 in total UPDRS (Part II+III) scores between P2B001 and Prami-ER were not significantly different (-8.35 ±0.86 vs 7.98 ±0.6); post-hoc analysis confirmed non-inferiority of P2B001 to Prami-ER (margin of 3 points, p=0.0052). Likewise, there were no significant differences between P2B001 and Prami-ER on UPDRS Part II (activities of daily living) or Part III (motor) scores. Overall, 74.1% of patients receiving P2B001 and 76.6% of patients receiving Prami-ER showed ≥4-point improvement in UPDRS Total scores (Odds ratio 0.87 [0.44, 1.75]; p=0.70). Overall, 74.7% of patients experienced ≥1 TEAE with P2B001 versus 86.5% with titrated Prami-ER and there was a lower frequency of dopaminergic-related TEAEs (44.7% versus 66.2%, respectively). Rates of somnolence (14.7% versus 31.1%) and orthostatic hypotension (2.7% versus 12.2%) were also lower with P2B001 compared with Prami-ER. 

These data indicate that P2B001 offers a once daily treatment option (without the need for titration) for patients with early PD with comparable efficacy to marketed Prami-ER but with reduced sleep-related and dopaminergic side effects. 

Authors/Disclosures
Lawrence W. Elmer, MD, PhD (Univ of Toledo Dept. of Neurology)
PRESENTER
Dr. Elmer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Acadia Pharmaceuticals. Dr. Elmer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Acorda Therapeutics. Dr. Elmer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amneal Pharmaceuticals. Dr. Elmer has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva Pharmaceuticals. The institution of Dr. Elmer has received research support from Vaccinex, Inc.. The institution of Dr. Elmer has received research support from Cynapsus Therapeutics, Inc.. The institution of Dr. Elmer has received research support from Lundbeck Pharmaceuticals, Inc.. The institution of Dr. Elmer has received research support from Intec Pharmaceuticals, Inc.. The institution of Dr. Elmer has received research support from Pharma Two B. The institution of Dr. Elmer has received research support from Acadia Pharmaceuticals, Inc.. The institution of Dr. Elmer has received research support from Impax Laboratories, LLC. The institution of Dr. Elmer has received research support from Prilenia Therapeutics. The institution of Dr. Elmer has received research support from Neuraly, Inc..
Pninit Litman, PhD (Pharma2b LTD) Dr. Litman has received personal compensation for serving as an employee of PHARMA 2B.
Hadas Friedman, Other (Pharma Two B) Mrs. Friedman has received personal compensation for serving as an employee of Pharma Two B.
Cheryl Fitzer-Attas, PhD (ClinMed LLC) Dr. Fitzer-Attas has received personal compensation for serving as an employee of Mitsubishi Tanabe Pharma America. The institution of Dr. Fitzer-Attas has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Cyclerion. The institution of Dr. Fitzer-Attas has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Pharma Two B. The institution of Dr. Fitzer-Attas has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Golden Heart Flower. The institution of Dr. Fitzer-Attas has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for B-Portal Biologics. Dr. Fitzer-Attas has stock in Golden Heart Flower.
Sheila Oren, MD, MBA (Neuroderm) Sheila Oren, MD, MBA has received personal compensation for serving as an employee of Neuroderm. Sheila Oren, MD, MBA has received personal compensation in the range of $0-$499 for serving as a Consultant for Neuroderm.