FDA approval for chewable ADHD tablets

Sep 7 2004

Alliant Pharmaceuticals has announced FDA approval of Methylin Chewable Tablets and Methylin Oral Solution for the treatment of ADHD. The two products are the first, and only, chewable tablet and oral solution for ADHD to gain FDA acceptance.

Compliance with any medical therapy is important. With children, the issue is pronounced, as swallowing pills can be a significant problem. Says Dr. Lyndon Waugh, M.D., Clinical Assistant Professor of Child and Adolescent Psychiatry at Emory University, "The release of this effective, well established medication for ADHD in liquid and chewable tablet form will allow physicians another alternative to carefully fine-tune a dosing strategy for each individual patient. And, it will help diminish family conflict and the child's anxiety when they have difficulty swallowing capsules or tablets."

Currently 26% of the total population has difficulty in swallowing tablets and capsules. This percentage is considered to be higher in the pediatric patient population.

ADHD is a disorder of the brain in which the individual repeatedly exhibits inappropriate impulsivity and/or inattention. According to the Attention Deficit Disorder Association, an estimated 3 to 7 percent of school- age children, and an estimated 4 percent of adults suffer from ADHD. The Attention Deficit Disorder Association was instrumental in convincing the U.S. Senate to sign a resolution designating September 7, 2004, "National Attention Deficit Disorder Awareness Day" in hopes of better educating the public about ADHD.

"As with any medication, compliance is critical," adds Mark Pugh, President and CEO of Alliant Pharmaceuticals. "Methylin Chewable Tablet and Methylin Oral Solution were designed specifically to help improve efficacy in treatment." Mr. Pugh adds that Alliant plans to release additional information on these products at the upcoming American Academy of Adolescent and Child Psychiatry meeting October 20 - 23rd in Washington D.C.

Methylin Chewable Tablets are available in a 2.5mg, 5mg and 10mg dose. The Methylin Oral Solution is available in a 5mg/5mL and 10mg/5mL dose.