DEERFIELD, Ill. — Lundbeck announced today that Onfi (clobazam) CIV will be available in scored tablet and oral suspension formulations beginning this week after the formulations were recently approved by the U.S. Food and Drug Administration. Onfi is a prescription medication originally approved by the FDA in 2011, and is used along with other medicines to treat seizures associated with Lennox-Gastaut syndrome (LGS) in adults and children 2 years of age or older. Onfi is an oral anti-epileptic drug (AED) of the benzodiazepine class, and is a 1,5 benzodiazepine. It is a federally controlled schedule four substance (CIV).
The new oval shaped Onfi scored tablets (10 mg and 20 mg) will replace the previously available round non-scored tablets, and are similar in size. These new tablets contain the same ingredients as the round tablet, and include a functional score to allow patients or their caregivers to split the tablets in half. Onfi will no longer be available in a 5 mg tablet. Onfi oral suspension (2.5 mg/mL) has a berry flavor, and provides an alternative to Onfi tablets.
“Since becoming available nearly two years ago, Onfi has become an important additional treatment option for people with LGS,” said Raman Sankar, MD, PhD, professor of neurology and pediatrics, and chief of pediatric neurology at the David Geffen School of Medicine at the University of California, Los Angeles. “Onfi scored tablets and oral suspension provide flexibility when making dose adjustments. Also, it’s very helpful to have medications available in both tablet and oral suspension formulations to provide options for patients and their caregivers.”
LGS is a rare and severe form of epilepsy that is typically diagnosed in childhood and often persists into adulthood. LGS is associated with multiple types of seizures with periods of frequent seizures, and daily seizures are common. Some of these seizures, including atonic, tonic and myoclonic seizures, may cause falls, or “drop seizures” (also referred to as “drop attacks”), which may result in injury.
“The availability of these new formulations are the result of working closely with the LGS community and listening to the needs of physicians, patients and those who care for them,” said Mike Hanley, director of Onfi marketing, Lundbeck US. “We are inspired by the strength of those impacted by LGS and will continue working together to help these patients and their families.”
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