Sun Pharma secures CDSCO panel okay for Amantadine ER Tablets to treat Parkinson
New Delhi: Pharmaceutical major, Sun Pharma, has got a go-ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) for the manufacturing and marketing of Amantadine ER Tablets 129/193mg for the treatment of Parkinson's disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.
This came after the drug maker presented a proposal for the manufacture and marketing of Amantadine ER Tablets 129/193mg, coupled with a bioequivalence study (BE) report and a request for a Clinical Trial (CT) waiver.
Amantadine is a synthetic tricyclic amine having both antiviral and dopaminergic activity. It is used in the therapy of influenza A and management of Parkinson disease. Amantadine works against the influenza A virus by inhibiting the release of infectious viral nucleic acids into host cells by interfering with the function of the viral M2 protein's transmembrane domain.
Amantadine's antiparkinsonian actions are mediated by increasing dopamine release from striatal dopaminergic nerve terminals and blocking presynaptic reuptake.
Amantadine was authorized by the FDA for use in the treatment of Parkinson's disease in 1973. The extended release formulation of Amantadin was authorized in 2017 for the treatment of levodopa-induced dyskinesia.
At 70th SEC meeting for Neurology and Psychiatry held on 23.07.2021 at CDSCO, the committee extensively evaluated the proposal presented by the drug-maker Sun Pharma for manufacturing and marketing Amantadine ER Tablets 129/193mg for the treatment of Parkinson's disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.
After detailed deliberation, the committee recommended grant of permission to manufacture and market Amantadine ER Tablets 129/193mg with clinical trial waiver for the treatment of Parkinson's disease and for the treatment of drug-induced extrapyramidal reactions in adult patients subject to condition that the firm should conduct a Phase-IV Clinical Trial and present the Phase IV Clinical Trial protocol before the Committee prior to launch of the product in the market.