Navigation Links
FDA Approves Onfi To Treat Severe Type of Seizures
Date:10/24/2011

SILVER SPRING, Md., Oct. 24, 2011 /PRNewswire-USNewswire/ -- On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. As Onfi is intended to treat a disease or condition that affects fewer than 200,000 people in the United States, it was granted orphan drug designation by the FDA.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

"Lennox-Gastaut syndrome is a severe form of epilepsy that causes debilitating seizures," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "This is a difficult condition to treat, and it will be helpful to have an additional treatment option."

Lennox-Gastaut syndrome usually begins before 4 years of age, and can be caused by a number of conditions, including brain malformations, severe head injuries, central nervous system infections, and inherited degenerative or metabolic conditions. In 30 to 35 percent of patients, no cause can be found. Patients commonly have frequent seizures of a wide variety, including tonic (stiffening of the body, upward deviation of the eyes, dilation of the pupils, and altered respiratory patterns), atonic (brief loss of muscle tone and consciousness, causing abrupt falls), atypical absence (staring spells), and myoclonic (sudden muscle jerks).

Most children with Lennox-Gastaut syndrome experience some degree of impaired intellectual functioning or information processing, as well as developmental delays and behavioral disturbances.

The effectiveness of Onfi, when added to ongoing seizure medication, was established in two multicenter controlled studies of patients 2 years of age and older. In each study, the drug was tested for the amount of reduction in the weekly frequency of drop seizures (atonic, tonic, or myoclonic seizures resulting in a fall or loss of posture) from the 4-week baseline period to a maintenance period. In both studies, patients taking Onfi had improved seizure control when compared to those taking control treatment (placebo in one study and low-dose Onfi in the other study).

Common adverse reactions reported by patients taking Onfi compared to those taking an inactive tablet (placebo) included somnolence, sedation, fever, drooling, constipation, cough, urinary tract infection, sleeplessness (insomnia), aggression, fatigue, upper respiratory tract infection, irritability, vomiting, problems swallowing (dysphagia), problems with coordination (ataxia), bronchitis, and pneumonia.  

Like other antiepileptic drugs, Onfi may increase the risk of suicidal thoughts or behaviors in a very small number of people taking the drug. Patients taking antiepileptic drugs should be monitored for depression, suicidal thoughts or behavior, and unusual changes in mood or behavior.

Onfi may slow thinking and impair motor skills; so, it is important that people taking the drug not drive, operate heavy machinery, or engage in other dangerous activities until they know how the drug affects them. Onfi can cause abuse and dependence. It has been categorized as a Schedule IV drug under the Controlled Substances Act. Onfi should not be discontinued suddenly. People using the drug should talk with their health care professional about slowly stopping the drug to avoid withdrawal symptoms.  

The FDA is requiring that a Medication Guide be given to patients and caregivers when Onfi is dispensed. The Medication Guide describes the risks and adverse reactions people should be mindful of when using the product.    

Onfi is manufactured by Catalent Pharma Solutions LLC, Winchester, Ky., for Lundbeck Inc. of Deerfield, Ill.  

For information

Approved Drugs: Questions and Answers http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

Developing Products for Rare Diseases and Conditions

http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Longer Duration Efficacy and Safety for EUFLEXXA®
2. FDA Approves Label Update for PREZISTA® to Include 192-Week Data in HIV-1-Infected Adult Patients Starting Treatment
3. FDA Approves Ferriprox to Treat Patients with Excess Iron in the Body
4. FDA Approves Combination Therapy Juvisync
5. FDA Approves Cialis to Treat Benign Prostatic Hyperplasia
6. FDA Approves Remicade to Treat Ulcerative Colitis in Children Older Than 6 Years
7. FDA Approves Soliris for Rare Pediatric Blood Disorder
8. FDA Approves New Indications for Prolia® (Denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy
9. FDA Approves Xalkori with Companion Diagnostic for a Type of Late-stage Lung Cancer
10. FDA Approves Firazyr To Treat Acute Attacks of Hereditary Angioedema
11. FDA Approves Adcetris to Treat Two Types of Lymphoma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)...  The Senior Care Pharmacy Coalition (SCPC) today ... Jason Chaffetz (R-UT) and Ranking Member ... , "Developments in the Prescription Drug Market," to ... about abusive pharmacy benefit manager (PBM) pricing practices. ... Member Elijah Cummings (D-MD) are diligent, serious lawmakers ...
(Date:2/4/2016)... , Feb. 4, 2016  Montoya Love is ... in the field of Pharmaceuticals. Montoya is the Regulatory ... Manufacturing and ... Becton Dickinson provides healthcare institutions, clinical laboratories ... throughout fifty countries across the globe. ...
(Date:2/4/2016)... Mettler-Toledo International Inc. (NYSE: MTD ) today announced ... highlights: , Sales in local currency increased ... Reported sales decreased 3% as currency reduced sales growth ... per diluted share as reported (EPS) were $4.44, compared ... was $4.65, an increase of 10% over the prior-year ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... February 05, 2016 , ... Stuart Bentkover, MD, FACS ... Designed to provide the most effective tattoo removal today, Dr. Bentkover is the only ... Developed by Cynosure, the PicoSure has been approved by the Food and Drug Administration ...
(Date:2/5/2016)... ... 05, 2016 , ... Colorize is a web theme package created ... next using Colorize's dynamic moving camera. Colorize is perfect for personal and web related ... environment with 1 to 5 focus points per scene, stage floor scene presets that ...
(Date:2/5/2016)... ... ... Health and wellness is a topic that should concern all Americans; however, ... an illness. Migraines are a severe form of a headache and often are accompanied ... the pain on their worst enemy, the feeling can last for many hours and ...
(Date:2/5/2016)... Ramsey, NJ (PRWEB) , ... February 05, 2016 ... ... Optimizing Primary Care for Patients with Rare Diseases, a continuing medical education (CME) ... conference is the first of its kind—and a first for ACCORD, whose mission ...
(Date:2/5/2016)... ... February 05, 2016 , ... KICVentures ( http://www.kicventures.com ) announced ... in New York City on Thursday, January 21, 2016. Kingsley R. Chin, ... alumnus of the varsity Columbia soccer program) spoke at the event, offering professional ...
Breaking Medicine News(10 mins):