Update on IPX203

[rebtar]

Sooooo…. FDA rejected the application.

“the FDA rejected carbidopa, one of the two main ingredients, and requested additional information about it. The agency noted that pharmacokinetic studies pointing to the safety of carbidopa have not been established and said more research is needed.”

This makes no sense to me. Anyone understand how they can reject carbidopa, with the long history it has in PD treatment?

beckershospitalreview.com/p....

[park_bear]

Per the company press release:

investors.amneal.com/news/p...

"The letter indicated that although an adequate scientific bridge was established for the safety of one ingredient, levodopa (LD), based on pharmacokinetic studies, it was not adequately established for the other ingredient, carbidopa (CD), and FDA has requested additional information. The letter did not identify any issues with respect to the efficacy or manufacturing of IPX203. Amneal will work closely with the FDA to address its comments and plans to meet with the agency to align on the best path forward."

FDA apparently mindlessly considering only the contents of the application and not the established history. Hopefully the company will be able to address these issues without this being a major setback.

[LAJ12345 in reply to park_bear]

whaaaat? This is crazy.

[park_bear in reply to LAJ12345]

yep.

[LAJ12345 in reply to park_bear]

probably because it destroys b6 so is clearly going to be bad for you, yet they have added it to drugs for years.

Makes you wonder what else they know about drugs already approved and aren’t saying in case they are held liable for allowing them.