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:
*Name:
*Comment:
*Email:


(Date:10/13/2017)... ... October 13, 2017 , ... ... alumni Hannah Randall, PharmD ‘17, and Jennifer Huggins, PharmD ’17, along with ... for the primary prevention of cardiovascular diseases during the 15th Annual Women’s ...
(Date:10/13/2017)... ... 13, 2017 , ... Apple Rehab Shelton Lakes , which specializes in ... the facility as part of a disaster drill on October 3rd. , Apple Rehab ... City Emergency Manager, as well as the Connecticut Long Term Care Mutual Aid ...
(Date:10/13/2017)... BASKING RIDGE, N.J. (PRWEB) , ... October 13, 2017 , ... ... second annual Holly Day Market. Featuring a collection of specialty vendors and unique items ... myriad of personalized and quality-focused health and wellness services offered by the VNA. ...
(Date:10/13/2017)... ... October 13, 2017 , ... Global Healthcare Management’s 4th Annual ... in Milford, NJ. This free event, sponsored by Global Healthcare Management’s CEO, Jon ... fun run is geared towards children of all ages; it is a non-competitive, non-timed ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, ... lowdown on sciatica in a new episode of "Success Files," which is an ... and innovation and investigates each subject in-depth with passion and integrity. , Sciatica ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... AMSTERDAM , Sept. 25, 2017   ... Trial Master File solutions, today—from the IQPC Trial ... Amsterdam , NL)—announced that EastHORN Clinical Services ... its clinical programs and TMF management. EastHORN, a ... Montrium,s eTMF platform to increase transparency to enable ...
(Date:9/19/2017)... Mich. , Sept. 19, 2017 HistoSonics, Inc., a venture-backed medical device company ... destruction of targeted tissues, announced three leadership team developments today:   ... PhD ... ... Veteran medical device executive Josh ...
(Date:9/12/2017)... Sept. 12, 2017   EcoVadis , the leading platform for environmental, ... first annual edition of its Global CSR Risk and Performance Index. The ... EcoVadis, based on Scorecard Ratings that analyzed nearly 800,000 data points across ... ... ...
Breaking Medicine Technology:
Cached News: