After already receiving FDA approval for a carbidopa/levodopa combination in 2015, Amneal Pharmaceuticals is once again at the regulator’s doorstep with another new combination of the decades-old Parkinson’s treatment.
The biopharma papers for IPX203 are now with the FDA, the company announced earlier this week.
The New Jersey biopharma already has an approved Parkinson’s disease drug known as Rytary, an extended-release formulation of the drug combo originally known as Sinemet. Impax Pharmaceuticals snagged this approval in 2015 and Amneal thereafter acquired the generic manufacturer in 2018.
In August 2021, Amneal said its latest extended-release oral capsules were better than an immediate-release version of the common carbidopa/levodopa combo in Parkinson’s disease. IPX203 has met the primary endpoint of the Phase III clinical trial of 506 patients with the CNS disorder that has baffled drug developers for decades.
Patients in the RISE-PD trial – which took place in the United States and Europe – experienced more “Good” times and less “Off” times when taking the extended-release version of Amneal, the company said.
Other companies have also secured FDA approvals for carbidopa/levodopa combinations, including Riverside Pharmaceuticals’ Dhivy in November 2021.
The initial approval of the combination of levodopa and carbidopa dates back to 1975, when the FDA gave the green light to Merck’s Sinemet. Generics have followed suit with Alembic Pharmaceuticals, Mylan and others.