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
Golin/Harris International

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:10/13/2015)... ... October 13, 2015 , ... Wimbledon Health ... and NCV testing, as well as pioneering the way for high schools, colleges ... hire of Ron Levitt as Chief Financial Officer. Levitt brings over 20 years ...
(Date:10/13/2015)... ... October 13, 2015 , ... Purdue University ... the Life Sciences Initiative aimed at enhancing Purdue’s life sciences research and graduate ... True” capital campaign. , The investment will result in cohesive efforts across several ...
(Date:10/13/2015)... ... ... "My friend's son suffers from eczema, and he had a horrible habit of ... Colo. "I came up with this kit as a way to prevent children from ... from rubbing or scratching his or her face. This protects sensitive skin from further ...
(Date:10/13/2015)... ... 13, 2015 , ... ProText Kinetic Panel is a typography creation tool made ... can create energetic text animations in any layout without the use of keyframes. Using ... timeline and stylize the text. With intuitive on-screen controls, users can re-position and scale ...
(Date:10/13/2015)... (PRWEB) , ... October 13, 2015 , ... ... through a unique private messaging application, announced today a significant contract that will ... five years. Independence plans to build on the growing success of its Relay ...
Breaking Medicine News(10 mins):
(Date:10/13/2015)... 13, 2015  Vitamin Angels – a charity that ... need of nutritional support - announced its work continues ... Nations (UN). The UN,s newly established Global Goals - ... recent follow up to the Millennium Development Goals established ... The new 17 Global Goals intend to address three ...
(Date:10/13/2015)... Generational Equity , a leading mergers and acquisitions advisor ... acquisition of its client, Quality Medical Rentals ... by Meridian Biomedical, Inc. (Meridian), headquartered in Colorado.  The ... Florida . To learn more, visit ... To learn more, visit www.qualitymedicalsouth.com . --> ...
(Date:10/13/2015)... -- The spine division of Zimmer Biomet (NYSE and SIX: ... its portfolio of innovative clinical solutions and technologies at ... 14-17, 2015, in Chicago , Illinois.  ... "Supplemental MIS Fixation Options for LLIF" NASS ... 1 p.m. --> "Supplemental MIS Fixation Options ...
Breaking Medicine Technology:
Cached News: