Summary of safety from clinical trial experience with IPX066, extended-release carbidopa-levodopa, in Parkinson’s disease (P1.184)

OBJECTIVE: To present the adverse event (AE) profile of IPX066 in the Phase 2/3 clinical trials in Parkinson’s disease (PD) BACKGROUND: IPX066 is an investigational, extended-release formulation of carbidopa-levodopa (CD-LD) designed to provide a rapid increase in plasma LD concentrations similar to immediate-release CD-LD, but with sustained stable concentrations to allow a dosing interval of every 6 hours in both early and advanced PD. IPX066 has demonstrated improvements in PD motor symptoms in early and advanced PD. DESIGN/METHODS: A total of 7 studies enrolled 1032 patients; 381 were LD-naive, early PD patients while all others had advanced PD. 978 patients (350 early, 628 advanced) were treated with IPX066. AEs were recorded at each clinic visit. RESULTS: A total of 258/350 early PD patients (73.7[percnt]) and 433/628 advanced PD patients (68.9[percnt]) had at least 1 AE. Nausea (11.6[percnt]), dizziness (8.3[percnt]), headache (7.9[percnt]), dyskinesia (7.6[percnt]), insomnia (6.1[percnt]), and falls (5.8[percnt]) were reported in 蠅5[percnt] of the overall Phase 2/3 PD population. Nausea (17.7[percnt]), dizziness (12.9[percnt]), and headache (12.6[percnt]) were the most frequent in early PD patients. In advanced PD, no single AE was reported by 蠅10[percnt] of patients; the most frequent AEs were dyskinesia (9.4[percnt]), nausea (8.1[percnt]), and falls (6.8[percnt]). Serious AEs occurred in 22 (6.3[percnt]) early and 70 (11.1[percnt]) advanced patients. 38 (10.9[percnt]) early patients and 51 (8.1[percnt]) advanced patients discontinued due to AEs. Nausea was the most frequent AE leading to discontinuation in both early (3.1[percnt]) and advanced (1.3[percnt]) patients. CONCLUSIONS: The tolerability profile of IPX066 was consistent with the known effects of CD-LD in the treatment of PD. SUPPORT: Impax Disclosure: Dr. Mark has nothing to disclose. Dr. Dhall has received personal compensation for activities with UCB Pharma, Impax Pharmaceuticals, and Teva Neuroscience. Dr. Kreitzman has received personal compensation for activities with Acadia Pharmaceuticals, UCB Pharma, Impax, Teva Neuroscience, Xenoport, US WorldMeds, and Lundbeck Research USA, Inc. as a consultant. Dr. Kell has received personal compensation for activities with Impax Laboratories as an employee. Dr. Khanna has received personal compensation for activities with Impax Pharmaceuticals as an employee. Dr. Hsu has received personal compensation for activities with Impax Laboratories as an employee. Dr. Gupta has received personal compensation for activities with Impax Laboratories as an employee.