sNDA (supplemental new drug application) of VIMPAT (lacosamide)an Anti-epileptic drug approved by US FDA as mono therapy in partial onset seizures .
Epilepsy is a chronic neurological disorder,which can occur across all ages,races and genders where in two or more unproved seizures occur at least one day ( 24 hours) apart .
VIMPAT(lacosamide) is available in various forms like tablets,oral solutions or injections .
Mono therapy is the treatment of a disease with a single drug which is opposite to combination therapy(multiple drugs) ,VIMPAT(lacosamide) is already approved in US as adjunctive treatment (with other drugs) for partial onset seizures in 17 years and older.
The adverse reactions seen in mono therapy study were similar to those in combination with others except insomnia which is greater than 2% .
VIMAT(lacosamide) Safety Information
-Suicidal behavior : Including VIMPAT, all Anti -Epileptic drugs (AED's) increase the risk of suicidal thoughts and change in formation of ideas or concepts.Patients under VIMPAT therapy shall be monitored for worsening of depression ,suicidal thoughts.
-Dizziness and Ataxia: VIMPAT may cause dizziness and ataxia and hence patients taking VIMPAT should be discouraged to perform /operate complex machinenary.