Onfi™ (clobazam) tablets now available in the US at retail pharmacies

H. Lundbeck A/S (Lundbeck) today announced 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 older1. Onfi™ is an oral anti-epileptic drug (AED) of the benzodiazepine class, and is a 1,5 benzodiazepine1. Onfi™ is a federally controlled schedule four substance (C-IV).

“We are very pleased that we now can make Onfi™ available in the US,” says Marie-Laure Pochon, Executive Vice President of Commercial Operations at Lundbeck, and continues: “LGS is a devastating disease and Onfi™ has in clinical studies shown to be an effective add-on therapy for seizures associated with LGS in adults and children two years and older.”

About Lennox-Gastaut Syndrome (LGS)

LGS is a rare and severe form of epilepsy that is typically diagnosed in childhood and often persists into adulthood2, 3. LGS is associated with multiple types of seizures with periods of frequent seizures, and daily seizures are common4. 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 injury2.

About Onfi™

Onfi™ is an oral antiepileptic drug developed in the United States by Lundbeck, and will be available in 5-mg, 10-mg, and 20-mg tablets. Onfi™ is a 1,5 benzodiazepine. The exact mechanism of action for Onfi™ is not fully understood, but is thought to involve potentiation of GABAergic neurotransmission resulting from binding at the benzodiazepine site of the GABAA receptor.

For more information, please visit, www.ONFI.com.

Important safety information

• Onfi™ can make you sleepy or dizzy and can slow your thinking and make you clumsy which may get better over time. Do not drive, operate heavy machinery, or other dangerous activities until you know how Onfi™ affects you. Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Onfi™ without first talking to your healthcare provider as your sleepiness or dizziness may get much worse.
• ONFI can cause withdrawal symptoms. Do not suddenly stop taking Onfi™ without first talking to a healthcare provider. Stopping ONFI suddenly can cause seizures that will not stop (status epilepticus), hearing or seeing things that are not there (hallucinations), shaking, nervousness, and stomach and muscle cramps.
• Onfi™ can be abused and cause dependence. Physical dependence is not the same as drug addiction. Talk to your healthcare provider about the differences. Onfi™ is a federally controlled substance (CIV) because it can be abused or lead to dependence.
• Like other antiepileptic drugs, Onfi™ may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have any symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings, and especially if they are new, worse, or worry you.
• Tell your healthcare provider about all of your medical conditions including liver or kidney problems, lung problems (respiratory disease), depression, mood problems, or suicidal thoughts or behavior.
• If you are pregnant or plan to become pregnant, Onfi™ may harm your unborn baby. You and your healthcare provider will have to decide if you should take Onfi™ while you are pregnant.
• Onfi™ can pass into breast milk. You and your healthcare provider should decide if you should take Onfi™ or breast feed. You should not do both.
• Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements as taking Onfi™ with certain other medicines can cause side effects or affect how well they work. Onfi™ may make your birth control medicine less effective. Talk to your healthcare provider about the best method to use.
• The most common side effects seen in Onfi™ patients include: sleepiness; drooling; constipation; cough; pain with urination; fever; acting aggressive, being angry or violent; difficulty sleeping; slurred speech; tiredness; and problems with breathing.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For more information, please see the Onfi™ Medication Guide and Full Prescribing Information.

Onfi™ is a trademark of Lundbeck.

Financial guidance

The content of this release will have no influence on the Lundbeck Group’s financial guidance for 2011 which was provided on 24 February 2011 in connection with the release of the financial results for 2010.

References

1. ONFI Full Prescribing Information. Deerfield, IL: Lundbeck. October 2011.
2. Van Rijckevorsel, Kenou et al. Treatment of Lennox-Gastaut syndrome: overview and recent findings. Neuropsychiatric Disease and Treatment. 2008: 4(6) 1001-1019.
3. Glauser, Tracey. Lennox-Gastaut Syndrome. Medscape. 2011. http://emedicine.medscape.com/article/1176735-overview. Last accessed 9/23/11.
4. Borggraefe I, Noachtar S. Pharmacotherapy of Seizures Associated with Lennox-Gastaut Syndrome. Clinical Medicine Insights: Therapeutics. 2010:2 15-24.