APPROVED: FDA OK's Sunovion epilepsy drug Aptiom
This article was originally published in Scrip
Sunovion Pharmaceuticals gained the US FDA's blessing to market Aptiom (eslicarbazepine acetate) as an add-on medication to treat partial-onset seizures associated with epilepsy, a neurological disorder caused by abnormal or excessive activity in the brain's nerve cells.
In approving Aptiom, the FDA determined it was not necessary to classify the medicine as a controlled substance.
But like other antiepileptic drugs, Aptiom's labeling comes with a warning the drug may cause suicidal thoughts or actions.
Aptiom was approved with a medication guide, which must be distributed each time a patient fills their prescription.
Sunovion said it expects Aptiom to be available in US pharmacies in the second quarter of 2014 for patients with partial-onset seizures, the most prevalent seizure type, accounting for 60% of new diagnoses in epilepsy, which affects about 2.2 million people in the US, according to the Centers for Disease Control and Prevention.
Dr Joseph Sirven, head of neurology at Mayo Clinic in Arizona and chair of the Epilepsy Foundation's Professional Advisory Board, noted that patients with partial-onset epilepsy often require adjunctive treatment to achieve better seizure control.
Aptiom's approval was based on three large randomized, double-blind, placebo-controlled, safety and efficacy Phase III trials, known as BIA 2093-301, BIA-2093-302 and BIA-2093-304, which included more than 1,400 patients with partial-onset seizures inadequately controlled by one to three concomitant antiepileptic drugs, including carbamazepine, lamotrigine, valproic acid and levetiracetam.
In the global studies, which were jointly performed with BIAL-Portela, treatment with Aptiom demonstrated statistically significant reductions in standardized seizure frequency versus placebo.
The results also showed that significantly more Aptiom-treated patients experienced seizure frequency reduction of 50% or more from baseline, 41% versus 22% for placebo-treated patients.
The most common adverse effects in patients taking Aptiom in the studies included dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision and tremor. The rate of discontinuation as a result of any adverse event was 14% for the 800mg dose, 25% for the 1,200mg dose and 7% of patients randomized to placebo.
Dr Antony Loebel, executive vice president and chief medical officer at Marlborough, Massachusetts-based Sunovion, noted that Aptiom is the second of the company's drugs to receive approval from the FDA this year, with Latuda (lurasidone HCl) gaining the agency's nod in late June as the first atypical antipsychotic to be approved in the US specifically for the treatment of major depressive episodes associated with bipolar I depression in adults either as monotherapy or adjunctive treatment to background therapy with lithium or valproate (scripintelligence.com, 2 July 2013).