New England Council member Sunovion received approval from the Food and Drug Administration (FDA) on their new once-daily pill for controlling seizures in epilepsy patients.
The approval of Aptiom will allow patients to take the drug on its own. Previously, the drug had been approved in 2013 for use in conjunction with other older drugs. The drug is an important milestone in the treatment of epilepsy, which affects about 140,000 people in New England and more than 1 million people in the United States. Aptiom is a once-daily non-extended release antiepileptic drug that will be available to first time patients or for patients to convert to from other antiepileptic drugs.
Sunovion’s Executive Vice President and Chief Medical Officer Anthony Loebel, M.D. stated, “We are pleased to have achieved FDA approval of a monotherapy indication for APTIOM, based on the results of two identically designed Phase 3 clinical studies conducted by Sunovion. Data from the monotherapy trials, in addition to the data generated from the adjunctive trials, confirm that APTIOM is efficacious and well-tolerated as adjunctive or monotherapy treatment within a daily dose range of 800 to 1,600 milligrams. Prescribers now have greater flexibility to optimize clinical response and tolerability when using APTIOM to treat people with partial-onset seizures.”
The New England Council congratulates Sunovion on their success with Aptiom.