Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced the presentation of results from its RYTARY TM (IPX066) Phase III and open-label extension trials at the 65 th Annual Meeting of the American Academy of Neurology in San Diego, CA on March 18, 2013. IPX066 is an investigational extended-release capsule formulation of carbidopa-levodopa being developed for the symptomatic treatment of adult patients with idiopathic Parkinson’s disease. The IPX066 data was presented as part of a poster session, entitled “Movement Disorders: Parkinson’s Disease Therapy.”
The presentation of IPX066 posters was as follows:
Date and Time (all posters):March 18, 2013 from 2:00-6:30, with authors in attendance from 5:30-6:30 PM (local time)
Presentation Title and Number:Long-Term Safety of IPX066 Extended-Release Carbidopa-Levodopa Capsules in Patients with Motor Fluctuations in Advanced Parkinson’s DiseaseAbstract / Poster Number: 3706/ P01.065Presentation Title and Number:Long-Term Safety of IPX066 Extended-Release Carbidopa-Levodopa Capsules in Patients with Early Parkinson’s DiseaseAbstract / Poster Number: 3662/ P01.064 Presentation Title and Number:Analysis of IPX066 Dosing Data in Advanced Parkinson's Disease (PD) PatientsAbstract / Poster Number: 49/ P01.063 On January 21, 2013, Impax received a complete response letter which indicated that the FDA could not approve the NDA for IPX066 at that time. The complete response letter stated that satisfactory resolution and verification of the deficiencies identified during the inspection of the manufacturing facility in Hayward, California would be required before the NDA for IPX066 may be approved. On March 4, 2013, the Company announced the receipt of a Form 483 following an inspection by the FDA of the Hayward facility. The Form 483 contained several observations specific to IPX066 which the Company believes must be satisfactorily resolved before the NDA for IPX066 may be approved. Open-Label Extension Study in Advanced Parkinson’s Disease (PD) PatientsAdvanced PD patients with motor fluctuations who completed either study B08-11, a Phase 2, randomized, open-label, 2-period (1 week per period), crossover pharmacokinetic and pharmacodynamic study of IPX066 vs. immediate-release carbidopa-levodopa (IR CD-LD ) or Study B09-02, a randomized, double-blind, active-controlled, parallel group, 13-week comparison of IPX066 vs. IR CD-LD, were eligible for study B09-03, an open-label extension study lasting 9 months. Three hundred forty nine (349) of 395 eligible advanced PD patients (88.4%) entered the open-label extension study and 313 completed. The most commonly reported adverse events (AEs) during the open-label extension trial were dyskinesia, fall, pain in extremity, hallucinations and arthralgia. The most common AEs reported in the previous trials were headache, nausea, dyskinesia, insomnia and dizziness.