The FDA has rejected Amneal Pharmaceuticals' new drug application for IPX203, which the company hoped would be approved for treatment of Parkinson's disease.
Though the drug was rejected by the agency, a July 3 news release from the pharmaceutical company notes that 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.
The FDA noted that the other main ingredient, levodopa, did meet its requirements. It also took no issue with the efficacy or manufacturing of IPX203.
"We are committed to advancing IPX203 for Parkinson's disease, which has been developed to provide a longer duration of therapeutic benefit than existing formulations with fewer doses," Chirag Patel and Chintu Patel, brothers and co-CEOs at Amneal, said in a statement. "We plan to work closely with the FDA to address the agency's feedback, and we remain confident in bringing this new treatment to Parkinson's patients as soon as possible."