Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced that data from the RYTARY TM 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
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 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.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV