Lundbeck announced today that ONFI (clobazam) tablets are now available for prescribing in the United States. We previously reported on ONFI in October when the FDA approved ONFI for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years and older. Clobazam is an oral anti-epileptic drug (AED) of the benzodiazepine class, and is a 1,5 benzodiazepine. ONFI is a federally controlled schedule four substance (C-IV).
ONFI is an oral anti-epileptic drug (AED) developed in the United States by Lundbeck, and will be available in 5-mg, 10-mg, and 20-mg tablets. The exact mechanism of action for clobazam is not fully understood, but is thought to involve potentiation of GABAergic neurotransmission resulting from binding at the benzodiazepine site of the GABAA receptor.
ONFI is available to patients at retail pharmacies with a prescription from a healthcare professional. Additionally, if a healthcare professional elects, Lundbeck has created the ONFI Support Center that will assist healthcare professionals and patients with benefits investigation, prior authorizations and is responsible for Lundbeck's patient assistance program. Where permissible, a sample voucher program will provide a free ONFI trial to any eligible patient. Also, co-pay assistance is being made available to those who are eligible. The Lundbeck ONFI Support Center is available by calling 855-345-6634.