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FDA Approves Generic of Banzel as Add-on Seizure Therapy

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FDA Approves Generic of Banzel as Add-on Seizure Therapy
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The U.S. Food and Drug Administration (FDA) has approved Lupin Limited’s generic medication, Rufinamide Oral Suspension, to be used as an add-on therapy to control seizures in adults and children, ages 1 and older, with Lennox-Gastaut syndrome (LGS), according to a press release.

Rufinamide is a generic version of Eisai’s Banzel Oral Suspension.

From a pharmacological and biological point of view, a generic is nearly identical to an original brand medication and has been tested for safety and effectiveness. However, it is normally sold at a much lower price.

Like the original brand medication, this new generic is made up of a solution that contains rufinamide — the therapy’s active ingredient — at a concentration of 40 mg/mL, which is meant to be taken orally with food, after being thoroughly shaken.

An anticonvulsant, rufinamide is thought to work by reducing the activity of sodium channels in the brain, which are thought to be one of the drivers of the excessive electrical brain activity leading up to seizures.

Recurrent seizures characterize LGS, a severe form of epilepsy that begins early in life and can lead to cognitive impairment, delays in reaching developmental milestones, and behavioral problems. LGS can be difficult to treat because it is resistant (refractory) to many antiseizure medications.

Rufinamide was originally developed by Novartis, which then agreed to pass the therapy’s exclusive development and commercial rights over to Eisai following a license agreement in 2004.

In the U.S., an oral tablet formulation of rufinamide, sold under the brand name Banzel, was originally approved in 2008 to be used in combination with other anti-epileptic medications. The combination therapy initially was prescribed to control seizures in children, ages 4 and older, and adults with LGS. Two years later, the FDA approved an oral suspension formulation of Banzel for the same indication, and in 2015 both therapy formulations were cleared to be used in children ages 1 and older.

In addition to this new generic version of Banzel by Lupin, similar generics marketed by BionPharma and Hikma are currently available in the U.S.

According to Iqvia, annual sales of Rufinamide Oral Suspension are estimated to amount to nearly $125 million in the U.S. alone, based on data gathered through September 2020.

The medication also is available in more than 20 countries worldwide, including Japan and in Europe, where it is sold under the brand name Inovelon.

The most common side effects observed in clinical trials of rufinamide in patients with severe forms of epilepsy, including LGS, include headache, dizziness, fatigue, somnolence or daytime drowiness, and nausea.

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