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[2] FDA Approves Metadate(TM) ER Tablets (CII), 10 Mg, a New Extended-Release Dosage for the Treatment of ADHD.

First 10 mg Extended-Release Tablet Offers Increased Dosing Flexibility

ROCHESTER, N.Y., Dec. 6 /PRNewswire/ -- Medeva Pharmaceuticals, a leading manufacturer of pharmaceuticals for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), recently received U.S. Food and Drug Administration (FDA) approval of Metadate(TM) ER Tablets (methylphenidate hydrochloride extended release tablets, USP), the first 10 mg extended-release methylphenidate tablet. This new 10 mg dosage offers physicians an extended- release strength of methylphenidate that has not before been available and may remove the need for midday dosing. The Metadate(TM) family of products also includes a 20 mg ER tablet.

"The new Metadate(TM) ER product line offers physicians more flexible dosing options that can help determine each patient's optimum methylphenidate dose. This is important because it may help patients achieve behavioral improvement using the lowest effective dose," says Terrance Coyne, M.D., vice president of medical, scientific and legal affairs, Medeva Pharmaceuticals, Inc.

Psychostimulants are the most widely used medications for the treatment of ADHD related symptoms. Short-term clinical studies have shown that approximately 70 percent of children with ADHD respond positively to psychostimulants.(1)

Methylphenidate is the most often prescribed drug for the treatment of ADHD.(2) Psychostimulant medications may decrease impulsivity and hyperactivity, increase attention and, in some children, decrease aggression.(3)

Drug treatment is not indicated in all cases of behavioral syndrome and should be considered only after conducting a complete history and evaluation of the patient.

Metadate(TM) ER Tablets (CII) (methylphenidate hydrochloride extended-release tablets, USP) are contraindicated in patients with marked anxiety, tension, agitation, glaucoma, motor tics, or with a family history or diagnosis of Tourette's syndrome. Metadate(TM) ER Tablets should be used with caution in patients with acute stress reactions, emotional instability, convulsive seizures with or without a history and/or EEG evidence of seizures, or hypertension. Metadate(TM) ER Tablets should not be used during pregnancy unless, in the opinion of the physician, the potential benefits to the patient outweigh the possible risks to the fetus. Caution should be used when prescribing Metadate(TM) ER Tablets concomitantly with coumarin anticoagulants, anticonvulsants, phenylbutazone, and tricyclic antidepressants. Metadate(TM) ER Tablets should not be used with MAO inhibitors or for 14 days after stopping use of an MAO inhibitor.

The most common adverse reactions are nervousness and insomnia. As with other drugs in this class, the possibility of tolerance and/or dependence, particularly in patients with a history of drug dependence, should be considered. Careful supervision is required during drug withdrawal since severe depression, as well as the effects of chronic overactivity, can be unmasked.

Facts About ADHD

ADHD affects three to five percent of all school-age children, and is considered the most frequently diagnosed psychiatric disorder in children and adolescents.(2)

The most common behaviors exhibited by those who have ADHD are inattention, hyperactivity and impulsivity. There are three types of ADHD:(4)

-- Inattentive ADHD: Children who exhibit many specific symptoms

including difficulty sustaining attention, avoidance of sustained

mental effort, distractibility and forgetfulness.

-- Hyperactive/Impulsive ADHD: Children who have trouble staying still,

are "always in motion," and talk nonstop.

-- Combined ADHD: Children who consistently exhibit symptoms of both

inattentive and hyperactive/impulsive ADHD.

Medeva Pharmaceuticals, Inc. is a U.S. subsidiary of London-based Medeva PLC (LSE: MDV-LS, NYSE: MDV). Medeva develops, manufactures and markets prescription pharmaceuticals, vaccines and immunotherapeutics worldwide. Medeva is a leader in the manufacture, research and development of pharmaceuticals for the treatment of ADHD.

For full prescribing information please call 800-753-0352 ext. 723

1. Elia J, Ambrosini PJ, Rapoport JL. Treatment of attention-deficit-hyperactivity disorder. N Engl J Med 1999; 340: 782, 783.

2. Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder. NIH Consens Statement 1998 Nov. 16-18; 16(2) p 4, 9: In press.

3. CH.A.D.D., "The Disability Named ADD, An Overview of Attention Deficit Disorders," 1993.

4. Diagnostic and Statistical Manual of Mental Disorders, 4th ed..DSM-IV. Washington, D.C.: American Psychiatric Association, 1994, pp 83-85.
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Date:Dec 6, 1999
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