Glaxo Wellcome Inc. Receives Approval to Market Lamictal For A Difficult-To-Treat Childhood Epilepsy

New Chewable, Dispersible Tablet Formulation an Added Benefit

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RESEARCH TRIANGLE PARK, N.C., Aug. 27 -- Glaxo Wellcome Inc. has received approval from the United States Food and Drug Administration (FDA) to market Lamictal(R) (lamotrigine) Tablets for the add-on treatment of generalized seizures associated with Lennox-Gastaut syndrome (LGS). This syndrome is one of the most severe and difficult-to-control forms of epilepsy in children and adults.

Lamictal has been available in the U.S. since 1994 as add-on therapy (prescribed in combination with other antiepileptic medications) for the treatment of partial seizures in adults with epilepsy and has been used by more than 1.38 million patients worldwide.

"Studies show that the addition of Lamictal significantly reduces seizures in patients with LGS. This represents a major therapeutic advance because so few medications have proven to be safe and effective for patients with this type of epilepsy," said Edwin Trevathan, MD, MPH, Pediatric Epilepsy Center, Washington University School of Medicine, St. Louis, Mo., who participated in the clinical trials.

The approval is based on a double blind, placebo-controlled study, published in the New England Journal of Medicine, that included 169 patients in 43 study sites. In that study, Lamictal or placebo was added to the patients' current antiepileptic drug regimen. Results show that patients treated with Lamictal as add-on therapy experienced significant reduction in the frequency of all major seizure types compared with patients receiving placebo (32% versus 9%). Drop attacks were significantly reduced by Lamcital (34%) compared to placebo (9%), as were tonic-clonic seizures (36% reduction for Lamictal versus 10% increase for placebo).

LGS is characterized by frequent seizures of several types, some of which cause falls and subsequent injuries. LGS patients often exhibit impaired intellectual function and developmental delay. The catastrophic condition usually develops between the ages of one and eight years and affects between three and 11 percent of children with epilepsy.

Because the seizures often are difficult to treat, most LGS patients maintain a treatment regimen that includes more than one type of antiepileptic drug. However, complete seizure control is rarely achieved. Many LGS patients have dose-related drug toxicity, as high doses of antiepileptic drugs are combined in an attempt to control seizures. Frequent changes in dose and type of medication are often necessary.

The most frequent adverse events ( > 10%) reported in the study were pharyngitis (sore throat) (14%) versus placebo (10%) and infections (13%) versus placebo (8%). Rash was reported by seven patients treated with Lamictal (9%) versus six patients on placebo (7%). Rash in two patients treated with Lamictal was serious, but resolved without after effect. The most commonly reported adverse experiences that led to discontinuation were rash for patients treated with Lamictal and deterioration of seizure control for patients treated with placebo.

A new chewable, dispersible form of Lamictal is available in 5 mg and 25 mg tablets. The new tablets can be chewed, swallowed whole or dissolved in liquid for administration by bottle or spoon for children, or for patients who have difficulty with administration, such as adults with disabilities and/or the elderly. The lowest available strength of Lamictal Chewable Dispersible Tablets is 5 mg, and only whole tablets should be administered. Additionally, since the dosing of Lamictal in pediatric patients is based on body weight, certain low-weight pediatric patients should not receive Lamictal because therapy cannot be initiated using dosing guidelines and the currently available tablet strengths. Lamictal will also remain available in its original tablet form for oral administration at 25 mg, 100 mg, 150 mg, and 200 mg.

Safety and effectiveness in patients below the age of 16 other than those with Lennox-Gastaut syndrome have not yet been established. Lamictal is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.

Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with the use of Lamictal. The incidence of these rashes, which have included Stevens-Johnson Syndrome is approximately 1% (1/100) in pediatric patients (age < 16 years) and 0.3% (3/1000) in adults. In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported, but their numbers are too few to permit a precise estimate of the rate. Lamictal should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug- related (See Box Warning in Prescribing Information).

Prior to initiation of treatment with Lamictal, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (e.g. fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately.

Lamictal (lamotrigine) is chemically unrelated to other antiepileptic drugs. Its mechanism of action on controlling seizures is unknown; however, in vitro pharmacological studies suggest that lamotrigine acts by stabilizing voltage-sensitive sodium channels, and preventing the neuronal release of aspartate and glutamate. These neurotransmitters contribute to excessive electrical discharge in groups of nerve cells in the brain which may result in recurrent seizures characteristic of epilepsy.

Glaxo Wellcome Inc., based in Research Triangle Park, N.C., is one of the nation's leading research-based pharmaceutical firms. A subsidiary of London-based Glaxo Wellcome plc, the company is committed to fighting disease by bringing innovative medicines and services to patients and to the health care providers who serve them. More information on Glaxo Wellcome Inc. is available at the company's website at www.glaxowellcome.com.

Web site: http://www.glaxowellcome.com

CONTACT: Ramona Jones of Glaxo Wellcome, 919-483-2839