Healthy Skepticism Library item: 1593
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Associated Press.
Novartis Gets FDA Approval for ADHD Drug
Forbes.com 2005 May 27;
Full text:
Novartis Pharmaceuticals Corp., a unit of Swiss drug maker Novartis AG, said Friday that the Food and Drug Administration approved an extended-release version of an Attention-Deficit/Hyperactivity Disorder drug it licenses from Celgene Corp.
The agency approved Focalin XR for the treatment of ADHD in adults, adolescents and children, based on clinical trial results that showed adults responded well to the treatment for over six months, and that young children responded to the treatment in about an hour.
The company estimates that ADHD effects 5 percent to 7 percent of children in the United States and about 4 percent of adults.
Novartis has an exclusive worldwide license to market Focalin from Celgene, the maker of Ritalin.
From the website, ADHD made simple:
Concerta, Focalin, and Ritalin Made Simple Makes it Easy to Understand These ADHD Drugs
Concerta, Focalin, and Ritalin are explained together since they are all a variation of a class of drugs called methylphenidates. Like, amphetimines, methylphenidates are central nervous system stimulants. These ADHD medications have demonstrated effectiveness in numerous clinical trials.
Scientists do not yet understand why these drugs relieve the symptoms of ADHD in some children.
One possible explanation for the success of Concerta, Focalin, and Ritalin is that they these ADHD medications regulate the release of norepinephrine in the brain. Norepinephrine is one of the chemicals our brain produces under stress. Research at the Brookhaven National Laboratory suggests another way that these drugs relieve ADHD. They discovered that methylphenidates increase the release of dopamine in the brain. Dopamine helps control the flow of information in the brain as well as bodily movements. Dopamine is speculated to improve attention and focus in people with ADHD who might not be releasing the chemical properly in their brains.
The difference between these drugs results from their delivery systems. By delivery systems, we mean that the Concerta, Focalin, and are released at different rates.
Concerta can be taken once daily and the effects of the medication last up to twelve hours. Concerta may be taken with or without food and does not significantly effect height or weight in children who use the drug over an extended period of time. Concerta has a low occurrance of side effects.
Ninety-six percent of patients taking Concerta have not reported any loss of appetite or sleep.
Focalin is the newest addition to the methylphenidate class of drugs to treat ADHD and is a chemical refinement of Ritalin that only used the most effective parts of the drug while leaving out the less effective parts. This is a twice a day drug with doses usually being taken four hours apart.
Ritalin comes in several forms. The regular release tablets should be taken two to three times a day, usually 30-45 minutes before a meal. The extended release tablets last up to eight hours and may be used in place of the regular tablets in some circumstances.
The methylphenidate class of drugs are controlled substances. They act on the brain in a similar way to cocaine. However, they have been deemed safe for the treatment of ADHD by the Food and Drug Administration. These drugs are controlled because they have a great potential for abuse by people seeking to get high.
