New Drug for LGS Patients Now Available
January 3, 2012
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.
Special note on Medicare coverage: Until 2008, with an effective date of 2013, the Medicare program had a prohibition on the coverage of benzodiazepines and barbiturates. Under the 2008 Medicare Improvements for Patients and Providers Act a provision was included to eliminate this prohibition, that is to permit coverage for benzodiazepines and barbiturates under Medicare Part D. The elimination of the ban on these drugs was a key priority for the Epilepsy Foundation and our advocates across the nation for more than two years. Coverage for benzodiazepines and barbiturates was prohibited under current law and will now be permissible with an effective date of January 1, 2013. At that point, plans will be permitted to include ONFI