Navigation Links
FDA Approves New Drug for Severe Epilepsy

Trials showed Banzel proved effective against Lennox-Gastaut syndrome

FRIDAY, Nov. 21 (HealthDay News) -- A new drug called Banzel (rufinamide) has been approved as a supplementary treatment for a severe form of epilepsy called Lennox-Gastaut syndrome, the U.S. Food and Drug Administration announced Friday.

The approval was based on results of a four-month clinical trial that included patients ages 4 to 30. Compared to patients who took a placebo, those who took the drug had 41 percent fewer tonic plus atonic seizures and 20 percent fewer seizures of any type, the agency said in a news release.

Common side effects included headache, dizziness, fatigue, drowsiness, double vision, nausea, vomiting, and problems walking.

As with all other antiepileptic drugs, Banzel will carry a warning that it may increase the risk of suicidal thoughts or behaviors. All patients who take Banzel must be given a patient medication guide that describes the risk of suicidal thoughts and behaviors associated with this class of drugs, the FDA said.

Banzel, manufactured by Eisai Medical Research Inc. of Woodcliff Lake, N.J., was granted "orphan drug status" by the FDA. This designation is given to a drug intended to treat a disease or condition that affects fewer than 200,000 people in the United States.

Lennox-Gastaut syndrome usually begins before age 4 and can be caused by brain malformations, severe head injury, central nervous system infection and inherited degenerative or metabolic conditions. No cause can be found in 30 percent to 35 percent of cases, the FDA said.

Patients with this form of epilepsy may experience periods of frequent seizures mixed with brief, relatively seizure-free periods. They suffer from varying types of seizures, 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 have some degree of impaired intellectual functioning or information processing, as well as developmental delays and behavioral issues.

"This approval offers another treatment option for patients who suffer from these debilitating, severe seizures," Dr. Russell Katz, director of the division of neurology products in the FDA's Center for Drug Evaluation and Research, said in the news release.

More information

Epilepsy Ontario has more about Lennox-Gastaut syndrome.

-- Robert Preidt

SOURCE: U.S. Food and Drug Administration news release, Nov. 21, 2008

Copyright©2008 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. FDA Approves Low-dose Regimen of PREMARIN Vaginal Cream to Treat Moderate to Severe Postmenopausal Dyspareunia – Painful Sexual Intercourse : Agency Grants New Indication for Bothersome Vaginal Symptom Associated with Menopause
2. FDA Approves Low-dose Regimen of PREMARIN Vaginal Cream to Treat Moderate to Severe Postmenopausal Dyspareunia - Painful Sexual Intercourse
3. Pennsylvania Insurance Department Approves Launch of Senior Health Care Oversight Trust
4. US FDA Approves 30-Minute Onset of Action for Focalin(R) XR, Bringing Potential Benefits to ADHD Patients During Early Morning Period
5. FDA Approves New Indication for Hospiras Precedex (Dexmedetomidine HCL) Injection
6. Triple-S Management Corporation Reports Third Quarter 2008 Results; Board Approves Share Repurchase Authorization of up to $40 Million
7. Kaiser Permanente Approves $12 Million in Community Benefit Grants in Third Quarter of 2008
8. Congress Sets New Course for Lung Cancer Research; Approves $20 Million for New Defense Department Program
9. FDA Approves Nasacort AQ(R) Nasal Spray for Children Aged 2-5 years old
10. ClearWay Minnesota(SM) Board Approves New Officers
11. FDA approves first drug for Huntingtons disease
Post Your Comments:
(Date:10/12/2017)... ... October 12, 2017 , ... First ... compliance program management, will showcase a range of technology and learning solutions at ... (NCAL) Convention and Expo to be held October 14–18, 2017 at the Mandalay ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... products to meet the demand of today’s consumer and regulatory authorities worldwide. From ... probiotic experts and tested to meet the highest standard. , These products ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... leader in post-acute health care, have expanded their existing home health joint venture ... , AccentCare has been operating a joint venture home health company with Asante, ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a leader in ... 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were announced ... 2017. , The annual award competition recognizes editorial and design excellence across a range ...
(Date:10/12/2017)... Mich. (PRWEB) , ... October 12, 2017 , ... ... has been named one of Michigan’s 2017 Best and Brightest in Wellness® by ... Brightest in Wellness® awards program on Friday, Oct. 20 from 7:30 a.m. to ...
Breaking Medicine News(10 mins):
(Date:9/22/2017)... 2017 AVACEN Medical (AVACEN) announced that its ... helping those with the widespread pain associated with fibromyalgia ... in Essex, England commented, "I ... experiencing no sleep at all, tremendous pain, with every ... recommend [the AVACEN 100] enough, how this has and ...
(Date:9/18/2017)... Pa. and KALAMAZOO, Mich. , Sept. 18, ... , and OptiMed Specialty Pharmacy of ... to offer a strategic hub service that expedites and ... sought-after personal spirometer, Spiro PD 2.0, and wellness management ... spirometer is a medical device used to measure lung ...
(Date:9/12/2017)... NEW YORK , Sept. 12, 2017   EcoVadis , the ... chains, has published the first annual edition of its Global CSR Risk ... 20,400 companies evaluated by EcoVadis, based on Scorecard Ratings that analyzed nearly ... ... Performance Index ...
Breaking Medicine Technology: