The US Food and Drug Administration (FDA) 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 Children’s 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.”
The recommended dose for monotherapy in patients 10 years of age and older is 400 mg/day in two divided doses. Approximately 58 percent of patients randomized to 400 mg/day achieved this maximal dose in the monotherapy controlled trial; the mean dose achieved in the trial was 275 mg/day.
“We are extremely pleased with the monotherapy approval for TOPAMAX,” said Gregory L. Barkley, M.D., chair of the Epilepsy Foundation’s professional advisory board. “This approval provides doctors with another important treatment option for their patients with epilepsy.”
To date, TOPAMAX has been used to treat more than 4 million patients worldwide. Currently, TOPAMAX is approved for use as a first-line treatment for epilepsy in more than 65 countries around the world.
Johnson & Johnson Pharmaceutical Research & Development (J&JPRD) L.L.C. discovered TOPAMAX and conducted the research for the new indication. TOPAMAX is marketed in the U.S. by Ortho-McNeil Neurologics, Inc.