Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced that data from the RYTARY
Phase III and open-label extension trials will be presented at the 65th Annual Meeting of the American Academy of Neurology in San Diego, California, held from March 16 to March 23. IPX066 is an investigational extended-release capsule formulation of carbidopa-levodopa for the treatment of idiopathic Parkinson’s disease.
The presentation of IPX066 posters is as follows:
Date: March 18, 2013 (all posters)Time: 2:00-6:30, with authors in attendance from 5:30-6:30 PM PT (all posters)Location: San Diego Convention Center Presentation Title and Number:Long-Term Safety of IPX066 Extended-Release Carbidopa-Levodopa Capsulesin Patients with Motor Fluctuations in Advanced Parkinson’s DiseaseAbstract / Poster Number: 3706/ P01.065 Presentation Title and Number:Long-Term Safety of IPX066 Extended-Release Carbidopa-Levodopa Capsulesin 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
RYTARY is an investigational extended-release capsule formulation of carbidopa-levodopa for the treatment of idiopathic Parkinson’s disease. It is not approved or licensed anywhere in the world. Results from the phase III studies of RYTARY, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD) have previously been announced.
On January 21, 2013, Impax received a complete response letter which indicated that the FDA could not approve the NDA 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.