Amneal asks FDA to approve another new formulation of Parkinson’s combo drug 

02 Sep 2022
endpts.com
Generic Drug
After having already received FDA approval for a carbidopa/levodopa combination in 2015, Amneal Pharmaceuticals is again at the regulator’s doorstep with another new combination of the decades-old Parkinson’s treatment. The biopharma’s papers for IPX203 are now at the FDA, the company said earlier this week. The New Jersey biopharma already has an approved Parkinson’s drug known as Rytary, an extended-release formulation of the medicine combo originally known as Sinemet. Impax Pharmaceuticals snagged that approval in 2015 and Amneal subsequently acquired the generics maker in 2018. In August 2021, Amneal said its latest extended-release oral capsules were better than an immediate-release version of the common Parkinson’s combo of carbidopa/levodopa. IPX203 met the primary endpoint in the Phase III clinical trial of 506 patients with the CNS disorder that has for decades befuddled drug developers. Patients in the RISE-PD trial — which took place in the US and Europe — experienced more “Good On” time and less “Off” time when taking Amneal’s extended-release version, the company said. Other companies have also won FDA nods for combinations of carbidopa/levodopa, including Riverside Pharmaceuticals’ Dhivy in November 2021. The original approval of the pairing of levodopa and carbidopa was in 1975, when the FDA gave the green light to Merck’s Sinemet. Generics have followed suit from the likes of Alembic Pharmaceuticals, Mylan and others.
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