Disease
UCB launches Vimpat® in the U.S. for Add-on Treatment of Epilepsy in Adults
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May 28, 2009 - 2:39:43 PM

(HealthNewsDigest.com) - ATLANTA – press release, regulated information – UCB today announced that Vimpat® (lacosamide), a new antiepileptic drug (AED) is available in the U.S. as an add-on therapy for the treatment of partial-onset seizures in people with epilepsy who are 17 years and older. Vimpat® will be available in U.S. pharmacies by the first week of June 2009.

"The availability of Vimpat® in the U.S. is an important milestone for people living with epilepsy and for UCB," said Rich Denness, Vice-President and General Manager CNS U.S., UCB. "Bringing Vimpat® to U.S. patients underscores UCB’s commitment to the epilepsy community and UCB's leadership position in this disease state."

Epilepsy affects approximately six million people in the U.S., Japan, U.K., France, Germany, Italy and Spain, and it can strike anyone at anytime.

"Vimpat® provides new hope in helping patients move closer to the goal of seizure freedom," said Steven S. Chung, MD, Director of Clinical Epilepsy Research at Barrow Neurological Institute in Phoenix. "Vimpat® can help patients across the treatment paradigm, from those recently diagnosed who have not achieved seizure control on current therapy, to those who have tried a variety of medications and are still suffering from frequent seizures."

The unmet medical need

Epilepsy is a common neurological disorder that can be life long, and is difficult to control with a single drug:

In a study of 525 people with epilepsy, less than half (47%) attained seizure control with the first AED
More than 30% of patients will continue to experience seizures despite trying two or more AEDs

"Vimpat® has a novel mechanism of action, and has been studied in combination with multiple AEDs as well as several commonly used medications with no clinically significant pharmacokinetic drug interactions observed in clinical trials. This demonstrates the importance and potential utility of including Vimpat® in partial onset epilepsy treatment regimens," said Kathleen Bos, MD, vice-president, medical affairs, U.S., UCB.

While treatment with one drug remains the goal of AED therapy and provides adequate control to many patients, almost 40% of patients with epilepsy receive suboptimal seizure control on monotherapy. In these situations, a physician may prescribe different treatments until one is found to provide adequate seizure control for the patient.

However, some studies indicate that when primary therapy is well-tolerated, but does not provide adequate seizure control, adding an additional AED to the current one provides more seizure control than continually switching therapies.

Vimpat® approval based on clinical trials with approximately 1,300 patients

The approval of Vimpat® is based on efficacy and safety data from one Phase II and two Phase III clinical trials with approximately 1,300 adults with epilepsy who had uncontrolled partial-onset seizures. Before adding Vimpat®, patients experienced a median baseline seizure frequency ranging from 10 to 17 seizures per month, despite being on one to three other AEDs; and 45.2 percent of patients had previously tried seven or more AEDs to control their seizures.

In the studies, patients taking Vimpat at 200 and 400 mg/day experienced a median percent reduction in seizure frequency per 28 days of 33.3% and 36.8%, respectively, versus only 18.4% reduction in the placebo group. Additionally, 34.1% and 39.7% of patients taking Vimpat at 200 and 400 mg/day, respectively, experienced ≥50% reduction in seizure frequency versus only 22.6% in the placebo group.

More patients randomized to Vimpat® also experienced improvement in seizure freedom rates, compared with placebo. Across the pivotal trials, 3.3% of patients randomized to 400 mg/day of Vimpat® were seizure free throughout the 12-week maintenance phase, vs. 0.9% of placebo patients. Seizure free days during the maintenance phase increased by a mean of 8% with 200 mg/day of Vimpat® and by 12% with 400 mg/day of Vimpat®, compared with 6% for placebo.

Patients began experiencing a reduction in seizures during the titration phase and maintained or had improved seizure control throughout the studies. The most common adverse events (>10 percent in the Vimpat®-treated group and greater than placebo) reported in these trials included dizziness, headache, nausea, and diplopia. More than half of the patients completing the clinical trials opted to continue treatment, some for longer than five years.

Vimpat® demonstrated efficacy and tolerability when combined with a broad range of existing AEDs, and also provided efficacy regardless of the number of concomitant AEDs. Vimpat was also studied with several commonly used medications, including digoxin, metformin, omeprazole, and an oral contraceptive (containing 0.03 mg ethinylestradiol and 0.15 mg levonorgestrel).

Vimpat® dosing should start at 50 mg twice daily and may be increased to a daily dose of 200 to 400 mg per day (recommended therapeutic dosing) administered in two divided doses. Vimpat® is available as oral tablets and as an intravenous (IV) infusion to allow for consistent treatment in an emergency room or hospital setting. These formulations are bioequivalent, meaning doses do not need to be adjusted when converting from IV to oral. The IV formulation of Vimpat® does not require dilution prior to administration.

Vimpat® was approved by the U.S. Food and Drug Administration in October 2008 for the adjunctive treatment of partial onset seizures in patients with epilepsy age 17 and over. Vimpat® has been designated as a Schedule V controlled substance by U.S. regulators.

In August 2008, the European Commission approved Vimpat® for the adjunctive treatment of partial onset seizures with or without secondary generalization in patients with epilepsy age 16 and over. Vimpat® is available in Germany, the U.K., Greece, Austria, Denmark, Sweden, and Netherlands, with other European countries to follow.

Vimpat® offers new way of targeting pathways involved in seizures

Preclinical studies indicate that Vimpat® has a novel mechanism of action, although the precise mechanism by which Vimpat® exerts its antiepileptic effect in humans is not yet clear.

In preclinical studies, the mechanism of action for Vimpat® has been shown to involve the modulation of sodium channel activity in the nervous system. Sodium channels play a crucial role in regulating the activity of the nervous system to help nerve cells communicate. Sometimes sodium channels are abnormally overactive and nerve cells become too excited, which may produce a seizure. The mechanism of action for Vimpat® is thought to reduce this sodium channel over-activity by enhancing the longer lasting inactive state of the channel, a different action compared with current sodium channel blocking drugs. This action then regulates the activity of over-excited nerve cells, which may contribute to the control of seizures.

Preclinical studies also suggest that Vimpat® binds to the collapsin response mediator protein-2 (CRMP-2), an important target that affects the way that nerves differentiate and grow. The precise nature of the interaction between Vimpat® and CRMP-2 and between CRMP-2 and seizure control is not known.

www.livebeyondepilepsy.com.

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