ONFI® (clobazam) CIV Scored Tablets and Oral Suspension Now Available in U.S. Pharmacies
DEERFIELD, Ill.--(BUSINESS WIRE)--
Lundbeck announced today that ONFI (clobazam) CIV will be available in
scored tablet and oral suspension formulations beginning this week.
These new formulations were recently approved by the U.S. Food & Drug
Administration (FDA). ONFI is a prescription medication originally
approved by the FDA in 2011, and is used along with other medicines to
treat seizures associated with Lennox-Gastaut syndrome (LGS) in adults
and children 2 years of age or older. ONFI is an oral
anti-epileptic drug (AED) of the benzodiazepine class, and is a 1,5
benzodiazepine. It is a federally controlled schedule four
The new oval shaped ONFI Scored Tablets (10 mg and 20 mg) will replace
the previously available round non-scored tablets, and are similar in
size. These new tablets contain the same ingredients as the round
tablet, and include a functional score to allow patients or their
caregivers to split the tablets in half. ONFI will no longer be
available in a 5 mg tablet. ONFI Oral Suspension (2.5 mg/mL) has a berry
flavor, and provides an alternative to ONFI Tablets.
Since becoming available nearly two years ago, ONFI has become an
important additional treatment option for people with LGS, said Raman
Sankar, MD, PhD, Professor of Neurology and Pediatrics and Chief of
Pediatric Neurology at the David Geffen School of Medicine at the
University of California, Los Angeles. ONFI Scored Tablets and Oral
Suspension provide flexibility when making dose adjustments. Also, its
very helpful to have medications available in both tablet and oral
suspension formulations to provide options for patients and their
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.
The availability of these new formulations are the result of working
closely with the LGS community and listening to the needs of physicians,
patients and those who care for them, said Mike Hanley, Director of
ONFI Marketing, Lundbeck US. We are inspired by the strength of those
impacted by LGS and will continue working together to help these
patients and their families.
Helpful resources for patients and their families, including an animated
video guide to the new formulations, are available at ONFI.com.
The website also features new content to support families, including
videos from parents of children and adults with LGS discussing their
experience with LGS and ONFI, as well as downloadable tools.
Jackie, whose daughter has LGS, is one of several parents who shares her
experience in a video on ONFI.com. LGS affects such a wide range of
people, and there really are no two people with LGS that are exactly
alike. That in itself is motivation to keep trying new things, said
Jackie. Several years back, my husband and I weighed the benefits and
the risks and ultimately decided that we would try ONFI for our
daughter, and were thankful that we did.
Please visit ONFI.com
to learn more.
ONFI is an oral antiepileptic drug developed in the United States by
Lundbeck, and is now available in 10-mg and 20-mg tablets, and as a 2.5
mg/mL Oral Suspension. 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 GABAreceptor.
More than 150,000 prescriptions of ONFI have been written in the United
For more information, please see the and
ONFI is a registered trademark of Lundbeck.
A wholly owned subsidiary of H. Lundbeck A/S of Denmark, Lundbeck in the
United States is headquartered in Deerfield, Illinois, and is committed
to providing innovative specialty therapies that fulfill unmet medical
needs of people with central nervous system (CNS) disorders, including
several therapies for people with challenging seizure disorders.
With a special commitment to the epilepsy community, Lundbeck makes a
scholarship available thats helped 39 people attend the LGS
Foundations Family & Professional Conference. Each year our employees
actively support and participate in hundreds of community-based
initiatives, including , an art therapy program Lundbeck
makes available with the Epilepsy Foundation. Learn more about our
epilepsy community programs at YourPartnerInEpilepsy.com.
Lundbeck is a global pharmaceutical company highly committed to
improving the quality of life of people living with brain diseases. For
this purpose, Lundbeck is engaged in the entire value chain throughout
research, development, production, marketing and sales of
pharmaceuticals across the world. The companys products are targeted at
disorders such as depression and anxiety, psychotic disorders, epilepsy,
Huntingtons, Alzheimers and Parkinsons diseases. Lundbecks pipeline
consists of several mid- to late-stage development programs.
Lundbeck employs more than 5,800 people worldwide, 2,000 of whom are
based in Denmark. We have employees in 57 countries and our products are
registered in more than 100 countries. We have research centers in
Denmark, China and the United States and production facilities in Italy,
France, Mexico, China and Denmark. Lundbeck generated revenue of
approximately DKK 15 billion in 2012. Lundbecks shares are listed on
the stock exchange in Copenhagen under the symbol LUN. Lundbeck has a
sponsored Level 1 ADR programme listed in the US (OTC) under the symbol
HLUYY. For additional information, we encourage you to visit our
corporate site www.lundbeck.com.
LundbeckMatt Flesch, 847-282-1154