FDA approves UCB epilepsy med, allows administration without titration

FDA cleared

Ease of administration is one of the main advantages of UCB's just FDA-approved epilepsy med Briviact. It can be initially delivered without titration, enabling patients to receive a full therapeutic dose right away.

Simple administration should improve tolerability, safety and compliance, since patients won't have to gradually escalate dosing of Briviact in order to monitor for serious side effects, as is the case with most other antiepileptic drugs.

According to the FDA website, the medicine's labeling will say, "When initiating treatment, gradual dose escalation is not required. The recommended starting dosage is 50 mg twice daily (100 mg per day). Based on individual patient tolerability and therapeutic response, the dosage may be adjusted down to 25 mg twice daily (50 mg per day) or up to 100 mg twice daily (200 mg per day)."

The labeling reflects the absence of a titration period in Briviact's fixed-dose, randomized double-blind pivotal clinical trials, which included 1,550 patients. In addition, the medicine can be injected when administration of oral film-coated tablets or solution is temporarily not feasible. The labeling warns that "the clinical study experience with Briviact injection is limited to 4 consecutive days of treatment."

Brussels-based UCB said discontinuation rates stemming from adverse events ranged from 5% to 8% depending on the dosage (50 mg/day, 100 mg/day or 200 mg/day).

Following a drug scheduling classification from the Drug Enforcement Administration within the next 90 days, the medication will hit the market as an adjunctive therapy (one used in combination with a primary treatment) to treat partial-onset seizures in epilepsy patients aged 16 or older.

"Patients can have different responses to the various seizure medicines that are available," said Dr. Billy Dunn, the director of the division of neurology products at the FDA's Center for Drug Evaluation and Research, in an FDA statement. "With the approval of Briviact, I am pleased that patients with epilepsy have a new treatment option."

The FDA approval comes on the heels of a nod from the European Commission. UCB is also filing for approval in Australia, Brazil, Canada, Russia, Switzerland and Turkey.

"The FDA's approval of Briviact is significant, because uncontrolled seizures can have serious, long-term effects, and approximately 30% of epilepsy patients remain uncontrolled on currently available treatments," said Dr. Pavel Klein, director of the Mid-Atlantic Epilepsy and Sleep Center in Bethesda, MD, in a UCB statement.

- read the UCB release and the FDA release