Zydus Cadila gets USFDA tentative nod for epilepsy treatment drug
Zydus Cadila has received tentative approval from the US Food and Drug Administration (USFDA) to market Brivaracetam tablets
Zydus Cadila had received tentative approval from the US health regulator to market epilepsy treatment drug Brivaracetam tablets. Zydus Cadila has received tentative approval from the US Food and Drug Administration (USFDA) to market Brivaracetam tablets, in the strengths of 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, Cadila Healthcare said in a regulatory filing. Zydus Cadila is a part of the Cadila group. Brivaracetam is used to treat partial-onset seizures (epilepsy).
Brivaracetam is an orally bioavailable levetiracetam derivative, with anticonvulsant activity. Although the exact mechanism through which brivaracetam exerts its effects is not fully known, this agent targets and binds to synaptic vesicle protein 2A (SV2A) in the brain. This prevents synaptic vesicle exocytosis and the synaptic release of certain, as of yet not fully known, excitatory neurotransmitters. This may inhibit impulse conduction across synapses, decrease neuronal (hyper-)excitability, and may modulate epileptogenesis. SV2A, a membrane glycoprotein present in neuronal synaptic vesicles, plays a key role in action potential-induced neurotransmitter release in the brain.
