UCB SA (UCBJF) announced positive primary efficacy and safety data from its latest multi-center, randomized, double-blind, placebo-controlled phase III study (N01358) on brivaracetam. N01358 is one of the four studies in the phase III program for brivaracetam.

The N01358 study evaluated fixed doses of brivaracetam (100 mg/day and 200 mg/day) without any up-titration in patients suffering from refractory partial-onset seizures who cannot be fully controlled with one or two concomitant antiepileptic drug. UCB is developing brivaracetam as an adjunctive therapy for the treatment of partial-onset seizures in adult patients suffering from epilepsy.

In the U.S. arm of the study, the primary efficacy endpoint compared the percentage reduction in partial-onset seizure frequency achieved by brivaracetam versus placebo every 28 days. Data showed that brivaracetam achieved a statistically significant reduction (22.8% for the 100 mg dose and 23.2% for the 200 mg dose) reduction in partial-onset seizure frequency per 28 days.

In the EU, the primary efficacy endpoint measured the proportion of patients achieving 50% or higher reduction in partial-onset seizure frequency from baseline to the end of the treatment period. Brivaracetam achieved 50% or higher reduction in partial-onset seizure frequency in 38.9% and 37.8% of patients in the 100 mg and 200 mg dosage arms, respectively, compared to 21.6% in placebo-treated patients.

The above data was presented at the annual meeting of the American Epilepsy Society. Based on the data, UCB intends to submit marketing applications for brivaracetam in the U.S. and the EU in early 2015.

Meanwhile, UCB is looking to gain approval for its epilepsy drug, Vimpat, in more countries. UCB intends to file for Vimpat in Japan and China as an adjunctive therapy for the treatment of epilepsy patients with partial-onset seizures in 2015. According to The Epilepsy Foundation of America and other sources, epilepsy is the fourth most common neurological disorder in the U.S. and approximately 65 million people suffer from the disease worldwide.

Investors looking for better-ranked stocks in the health care sector may consider Sucampo Pharmaceuticals, Inc. (SCMP), Valeant Pharmaceuticals International, Inc. (VRX) and Lannett Company, Inc. (LCI). All these stocks carry a Zacks Rank #1 (Strong Buy).

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