New Formulation of Antiepileptic Drug Gets the FDA Green Light

Patients with epilepsy will soon have another option to control seizures with the approval of a new formulation of perampanel (Fycompa), developed by Eisai Inc.

Patients with epilepsy will soon have another option to control seizures with the approval of a new formulation of perampanel (Fycompa), developed by Eisai Inc.

The US Food and Drug Administration (FDA) approved the drug on May 2 as an adjunctive therapy to treat partial-onset seizures (POS) with or without secondarily generalized seizures and primary generalized tonic-clonic (PGTC) seizures.

Fycompa is already available in 43 countries in 2 mg, 4 mg, 6 mg, and 8 mg, 10 mg, and 12 mg tablets. The updated formulation is now a CIII Oral Suspension — which is intended for patients with epilepsy who are at least 12 years old.

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“We are excited about the approval of Fycompa Oral Suspension, as it gives another option to patients with epilepsy who may have difficulty swallowing tablets or prefer liquids,” Lynn Kramer, MD, chief clinical officer and chief medical officer of Neurology Business group at Eisai, said in a news release.

It was only last month that researchers revealed the positive phase III results of Fycompa at the American Academy of Neurology (AAN) 68th annual meeting in Vancouver, Canada.

The medication is expected to hit the market in June 2016. The most common side effects are dizziness, sleepiness, headache, falls, nausea, problems with muscle coordination and walking normally, and weight gain.

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