Impax Pharmaceuticals announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the RYTARY™ (IPX066) New Drug Application (NDA) from October 9, 2014, to January 9, 2015.

The Company amended the chemical, manufacturing and control (CMC) section of the RYTARY NDA subsequent to its submission of responses to the July 26, 2014 Form 483 observations at the Taiwan facility. The FDA notified the Company that such amendment constituted a major amendment. Since the receipt date of this additional information is within three months of the PDUFA date, the FDA has extended the PDUFA date to review the information. No additional information was requested by the Agency.

RYTARY (IPX066) is an investigational extended-release capsule formulation of carbidopa-levodopa for the treatment of Parkinson's disease. It is not approved or licensed anywhere in the world. Results from the pivotal phase III studies of IPX066, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD) were positive and have previously been announced and approved by the FDA. However, they never received final FDA approval due to ongoing problems at their manufacturing facility. After an extensive delay, and supposed improvements, the FDA was going to conduct another inspection prior to Oct 9. However, this has now been delayed again for another three months.


http://www.marketwatch.com/story/imp...015-2014-09-17

just wonder why they think there's a market for a slightly better controlled release sinemet? i don't think they went head to head against STALEVO. maybe there is a population that can't tolerate COMTAN or other adjuncts to C/L?

it's going to be expensive, wonder how insurance companies will reimburse with cheaper STALEVO? i'm only taking C/L, temporarily had extreme wearing off after bedtime where pain from back and abdomen rigidity woke me up and i had to take a C/L to relieve the rigidity. strangely episode lasted 3 days and now back to "normal". so i'd buy a pill that lasted longer that didn't contain COMTAN that i could take just at night but i don't think RYTARY is even close.

If there was ever a drug that needed to be licensed (or sold) out to another manufacturer, it's RYTARY. Even if they eventually receive final FDA approval to launch the drug, who would want to trust Impax on the production quality.

Can you provide or direct me to any detailed info on the responses to the July 26 Form 483 and the changes made when Impax amended the CMC section of the Rytary NDA.

"The Company amended the chemical, manufacturing and control (CMC) section of the RYTARY NDA subsequent to its submission of responses to the July 26, 2014 Form 483 observations at the Taiwan facility. The FDA notified the Company that such amendment constituted a major amendment."

My wife had to stop Rytary 145 2 capsules 6 times per day (every 4 hour) because of severe dyskinesia which she never had while on
C/L 25/100. She went back on C/L and the dyskinesia gradually reduced and disappeared after 4 days.

stanjay

Sorry stanjay, but I haven't seen the 483, or the subsequent extension.

Sorry to hear that your wife has had problems with it. All-in-all, most people I've spoken with that have started Rytary are quite happy with it. Some have had an adjustment period to get the dosage right. However, I've heard of a few stories, like yours, where it just could not be tolerating. I'm not sure why, but that is true with almost every drug.
Good luck!

Thanks, I was wondering how you knew about the change in the formulation. I hadn't read about it but found the FDA approval letter interesting in that it required Impax to do further testing.
Stanjay