RYTARY TM (IPX066) (Carbidopa and Levodopa) Extended-Release Capsules Phase III and Open-Label Extension Data to be Presented at the American Academy of Neurology Conference
HAYWARD, Calif.–(BUSINESS WIRE)– Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NAS: IPXL) , today announced that data from the RYTARYTM 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 Capsules in Patients with Motor Fluctuations in Advanced Parkinson’s Disease Abstract / Poster Number: 3706/ P01.065
Presentation Title and Number: Long-Term Safety of IPX066 Extended-Release Carbidopa-Levodopa Capsules in Patients with Early Parkinson’s Disease Abstract / Poster Number: 3662/ P01.064
Presentation Title and Number: Analysis of IPX066 Dosing Data in Advanced Parkinson’s Disease (PD) Patients Abstract / Poster Number: 49/ P01.063
|
About RYTARY TM (IPX066)
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 …read more
Source: FULL ARTICLE at DailyFinance