HOME >> MEDICINE >> NEWS
FDA approves new indication for Topamax as initial monotherapy for adults and children with epilepsy

TITUSVILLE, NJ, June 30, 2005 -- The U.S. Food and Drug Administration (FDA) yesterday approved a new use for TOPAMAX (topiramate) Tablets and TOPAMAX (topiramate capsules) Sprinkle Capsules as initial monotherapy in patients 10 years of age and older with partial-onset or primary generalized tonic-clonic seizures.

Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than two seizures in the three months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.

"Anti-epilepsy medications, or neuromodulators, are selected based on seizure type; however, the specific seizure type may not always be obvious at the time of diagnosis," said Tracy Glauser, M.D., director of the Comprehensive Epilepsy Center at the Cincinnati Childrens Hospital. "A treatment like TOPAMAX, which provides coverage for both partial-onset and primarily generalized tonic-clonic seizures, offers doctors an option in situations where differentiating between these seizure types is difficult."

Epilepsy is characterized by seizures, which are abnormal electrical discharges in the brain that temporarily disrupt normal brain function. Seizures are classified as "generalized," originating in both sides of the brain simultaneously, or "partial-onset," starting in one area of the brain.

In a double-blind clinical trial, 470 patients with partial-onset or primary generalized tonic-clonic seizures were randomized to treatment with 50 mg or 400 mg/day of TOPAMAX. The primary efficacy assessment was a group comparison of time to first seizure during the double-blind phase of the study. Comparison of the Kaplan-Meier survival curves of time to first seizure favored the 400 mg/day group over the 50mg/day group. The recommended dose for monotherapy in patients 10 years of age and older is 400 mg/da
'"/>

Contact: Debbie Harvey
dharvey@golinharris.com
312-729-4374
Golin/Harris International
30-Jun-2005


Page: 1 2 3

Related medicine news :

1. DFG approves 11 new Collaborative Research Centers
2. FDA approves ZYFLO CR extended-release tablets for chronic treatment of asthma
3. FDA approves Dey, L.P.s Perforomist inhalation solution for maintenance treatment of COPD
4. VCR -- FDA approves home discharge for US patients
5. FDA approves prescription Zaditor for over-the-counter relief from itchy eyes
6. FDA approves Vectibix to treat patients with metastatic colorectal cancer
7. 5,000 rare diseases need drugs, but Europe only approves a handful each year
8. FDA approves room temperature storage of ZLB Behrings Helixate FS
9. FDA approves first blood test to predict risk for stroke
10. FDA approves Boostrix a new US vaccine for adolescents against pertussis
11. Majority of herb users dont follow evidence-based indications, researchers find

Post Your Comments:
(Date:8/28/2015)... Tempe, AZ (PRWEB) , ... August 29, 2015 , ... ... to reinvent higher learning and the student experience as part of the EDUCAUSE - ... Melinda Gates Foundation . , This is the third Breakthrough Models Incubator ...
(Date:8/28/2015)... ... August 28, 2015 , ... An online provider of ... make the purchase of CPAP equipment more affordable by offering shipping at no cost ... of CPAP products and orders of any size. My Cpap Store is located in ...
(Date:8/28/2015)... ... , ... The Kentucky State Department of Workforce Investment Commissioner Beth Kuhn recently ... for, they are unable to pass the initial drug test and therefore unable to ... order to be able to hire long-term, skilled talent. (1) Will Wesch, Director of ...
(Date:8/28/2015)... Mendon, IL (PRWEB) , ... August 28, 2015 , ... ... Mission” benefit concert returned for the second year to the Adams County Fairgrounds in ... event was held to raise money to support music education in the underfunded school ...
(Date:8/28/2015)... VA (PRWEB) , ... August ... ... Risk Management for Medical Devices:, Understanding the FDA’s Position and Best Practices ... MD, http://www.fdanews.com/cybersecuritymd , This workshop, chaired by internationally renowned expert ...
Breaking Medicine News(10 mins):Health News:Rio Salado College Joins 9 Educational Leaders to Reinvent Higher Learning 2Health News:Rio Salado College Joins 9 Educational Leaders to Reinvent Higher Learning 3Health News:Rio Salado College Joins 9 Educational Leaders to Reinvent Higher Learning 4Health News:My Cpap Store Now Offering Delivery Special 0 Cost to You 2Health News:Hiring Obstacles: Drug Abuse a Problem for Workforce 2Health News:Hiring Obstacles: Drug Abuse a Problem for Workforce 3Health News:Hiring Obstacles: Drug Abuse a Problem for Workforce 4Health News:Best Drug Rehabilitation Interviews Country-Rock Duo Highway Run at the 2015 "Music With A Mission" Benefit Concert 2Health News:FDAnews Announces — Software and Cybersecurity Risk Management for Medical Devices: Understanding the FDA’s Position and Best Practices for Compliance, Oct. 14-15 2Health News:FDAnews Announces — Software and Cybersecurity Risk Management for Medical Devices: Understanding the FDA’s Position and Best Practices for Compliance, Oct. 14-15 3Health News:FDAnews Announces — Software and Cybersecurity Risk Management for Medical Devices: Understanding the FDA’s Position and Best Practices for Compliance, Oct. 14-15 4Health News:FDAnews Announces — Software and Cybersecurity Risk Management for Medical Devices: Understanding the FDA’s Position and Best Practices for Compliance, Oct. 14-15 5
(Date:8/28/2015)... and LONDON , August 28, 2015 /PRNewswire/ ... approach seamlessly connects people, technologies and ... improving outcomes and the cost of healthcare ... AEX: PHIA) today announced its presence at  ESC Congress 2015 ... including Heart Model A.I. , EchoNavigator and IntelliSpace Cardiovascular, that ...
(Date:8/27/2015)... -- DURECT Corporation (Nasdaq: DRRX ) announced today ... healthcare conferences.  , James E. ... Rodman & Renshaw Investment Conference on Thursday, September 10 ... held at the St. Regis Hotel in ... of the presentation will be available by accessing ...
(Date:8/27/2015)... 2015  Eli Lilly and Company (NYSE: LLY ... on Thursday, September 17, 2015. Sue Mahony , ... and Richard Gaynor , M.D., senior vice president ... will participate in a fireside chat at 3:30 p.m., ... webcast will be available on the "Webcasts & Presentations" ...
Breaking Medicine Technology:Philips Showcases New Integrated Cardiology Solutions to Advance Minimally Invasive Procedures at ESC Congress 2015 2Philips Showcases New Integrated Cardiology Solutions to Advance Minimally Invasive Procedures at ESC Congress 2015 3Philips Showcases New Integrated Cardiology Solutions to Advance Minimally Invasive Procedures at ESC Congress 2015 4DURECT to Participate in Upcoming Healthcare Conferences 2Lilly to Participate in Morgan Stanley Global Healthcare Conference 2
Cached News: