Lundbeck announces availability of ONFI Tablets in the U.S.

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Lundbeck announced today that ONFI Tablets are now available for prescribing in the United States. The FDA recently approved ONFI for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years and older. ONFI is an oral anti-epileptic drug (AED) of the benzodiazepine class, and is a 1,5 benzodiazepine. ONFI (pronounced "ON-fē") is a federally controlled schedule four substance (C-IV).

"The availability of ONFI is the result of extensive efforts over many years by our team here at Lundbeck and the medical community," said Staffan Schüberg, president of Lundbeck in the U.S. "We have been inspired by the courage of patients and families impacted by LGS, and their strength never to give up on the goal of additional seizure management. Recognizing the need for additional treatment options due to the intractable nature of this challenging seizure disorder, we are very pleased to make ONFI available in the U.S."

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.

"LGS can take a toll on even the strongest families due to the frequency and severity of seizures, including drop seizures." said Yu-Tze Ng, director of epilepsy at the University of Oklahoma Medical School and lead investigator of clinical trials supporting the approval of ONFI. "In clinical trials, ONFI was shown to be an effective add-on therapy for seizures associated with LGS in adults and children two years and older. ONFI's availability is important news for patients and their caregivers to discuss with physicians."



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