Onfi (clobazam) tablets now available in the US at retail pharmacies
Onfi™ is now available in the US for
Lennox-Gastaut syndrome, a rare orphan epilepsy disorder
Lennox-Gastaut syndrome is one of the most
severe forms of epilepsy and there is a clear need for new
treatment options
Onfi™ has the potential to contribute to
Lundbeck's growth opportunities in the years to come
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.
Lundbeck contacts
Investors: Media:
Palle Holm Olesen Mads Kronborg
Chief Specialist, Investor Relations Media Relations
Manager
palo@lundbeck.com mavk@lundbeck.com
+45 36 43 24 26 +45 36 43 28 51
Magnus Thorstholm Jensen Simon Mehl Augustesen
Investor Relations Officer International Media
Specialist
matj@lundbeck.com smeh@lundbeck.com
+45 36 43 38 16 +45 36 43 49 80
Jacob Tolstrup
Vice President
jtl@lundbeck.com
+1 847 282 5713
About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international
pharmaceutical company highly committed to improving the quality of
life for people suffering from brain disorders. For this purpose,
Lundbeck is engaged in the research, development, production,
marketing and sale of pharmaceuticals across the world. The
company's products are targeted at disorders such as depression and
anxiety, schizophrenia, insomnia, epilepsy and Huntington's,
Alzheimer's and Parkinson's diseases.
Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark. Today Lundbeck employs approximately 5,900 people worldwide. Lundbeck is one of the world's leading pharmaceutical companies working with brain disorders. In 2010, the company's revenue was DKK 14.8 billion (approximately EUR 2.0 billion or USD 2.6 billion). For more information, please visit www.lundbeck.com.
Sources
ONFI Full Prescribing Information. Deerfield,
IL: Lundbeck. October 2011.
Van Rijckevorsel, Kenou et al. Treatment of
Lennox-Gastaut syndrome: overview and recent findings.
Neuropsychiatric Disease and Treatment. 2008: 4(6) 1001-1019.
Glauser, Tracey. Lennox-Gastaut Syndrome.
Medscape. 2011. http://emedicine.medscape.com/article/1176735-overview.
Last accessed 9/23/11.
Borggraefe I, Noachtar S. Pharmacotherapy of
Seizures Associated with Lennox-Gastaut Syndrome. Clinical Medicine
Insights: Therapeutics. 2010:2 15-24.
Posted: January 2012
