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Epilepsy Drug Keppra (Levetiracetam) Approved by FDA in Oral Solution

SMYRNA, GA -- July 17, 2003 -- The U.S. Food and Drug Administration (FDA) has approved grape-flavored, dye-free Keppra® (levetiracetam) oral solution (100 mg/mL), providing a new option for patients with epilepsy who prefer a liquid or cannot swallow tablets.

Keppra tablets were approved by the FDA in November 1999 for the adjunctive treatment of partial onset seizures in adults with epilepsy, and Keppra oral solution, approved for the same indication, is expected to be available through pharmacies this fall.

Worldwide, epilepsy is the most common neurological disorder, even more common than Alzheimer's disease,(1) and it can strike at any time. Epilepsy affects approximately 2.3 million Americans, and in the elderly, an estimated 61,000 new cases occur each year.(2)

"Keppra oral solution provides physicians with a new dosing option that may be ideal for patients who prefer the convenience of a liquid," said Blanca Vazquez, MD, assistant professor of neurology and director of clinical trials at New York University Medical Center-Mt. Sinai's Comprehensive Epilepsy Center. "Especially for the elderly -- who are often on multiple medications -- having access to a drug like Keppra that has an effective starting dose and lacks drug interactions is ideal."

"In slightly more than three years, Keppra tablets have been used by more than 200,000 patients,"(3) said Anthony Tebbutt, president of UCB Pharma, Inc. "We believe that the addition of a liquid form of Keppra further extends its value through greater flexibility in dosing."

Study Design and Results

To confirm bioequivalence of Keppra oral solution to Keppra tablets, healthy adult volunteers participated in a crossover study comparing Keppra oral solution (7.5 mL of a 100 mg/mL solution) with the tablet formulation (750 mg). Keppra plasma concentrations were determined prior to dosing as well as at regular intervals between 10 minutes and 36 hours after dosing.

Results found that the 10 percent oral solution of Keppra was bioequivalent to the tablet formulation in healthy volunteers. The pharmacokinetic (PK) parameters reported in this study are similar to PK parameters reported for the tablet formulation in previous studies of healthy volunteers. The plasma concentration versus time curves for the oral solution and tablet formulations were essentially superimposable for both linear and log-transformed data. The 90 percent confidence intervals for the difference between formulations in AUC, AUC_(0-t) and C_max were within 80 percent to 125 percent, the limits indicating bioequivalence.

Keppra use is associated with the occurrence of central nervous system adverse events, including somnolence and fatigue, coordination difficulties and behavioral abnormalities, and with minor, but statistically significant, hematological abnormalities. Keppra dosing must be individualized according to renal function status. In well-controlled clinical studies, the most frequently reported adverse events associated with the use of Keppra in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, were somnolence, asthenia, infection and dizziness.

REFERENCES:
1. The World Health Report 2001, "Mental Health: New Understanding, New Hope" World Health Organization, http://www.who.int/whr/2001/main/en/media/disorders.htm (Last accessed 5/27/03)
2. http://www.efa.org/epusa/nation/nation.html (accessed 5/8/03)
3. Based on NDCHealth™ Retail Pharmacy Database through November 2002. Does not include patients treated with Keppra ® outside the U.S.


SOURCE: UCB Pharma, Inc.

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