Only licensed clinical trial, 21.2million doses from Novartis creates database of medications for children and adolescents

US health regulators approved a drug for people with attention deficit hyperactivity disorder (ADHD) on Friday. The drug, sold as a single injection or twice daily in 30-mg doses, is to be given to patients age 6 and older and is the first for adults to be approved specifically for that age group.

Companies such as Pfizer and Mylan, which earlier this year withdrew three ADHD medications they had filed for approval, as well as the makers of Ritalin – the world’s most prescribed ADHD medication, with annual sales of $3.6bn, according to market researchers IMS Health – face headwinds as a result of the new FDA-approved medication, Novartis’s GATTEX.

Of late, company officials have suggested that it’s inevitable that the market for ADHD drugs will see a plateau of sales. Aflatitizers, more widely used than prescription stimulants such as Ritalin, have yet to meet the FDA’s requirements to approve on their own for ADHD in children and adolescents, but are now FDA-approved for that indication.

Last month, representatives from Novartis announced the product had met the product guidelines for ADHD among other indications.

In prescribing documents posted online by the FDA, the agency said the GATTEX product was similar to another ADHD medication called Ritalin. The Novartis product has been available since 2007 to adults in the US and was FDA-approved as an adult ADHD prescription treatment as of 1 January 2014.

Backers of the GATTEX product say it can be administered more easily by adults because it involves using less tablet-like liquid. Researchers conducted a clinical trial that found that patients were far more likely to be compliant, report fewer side effects and improve their concentration.

A claim that the product was only administered in an external clinical trial had not been considered a quality-of-life issue because it did not in fact require the usual approval from the FDA for such a study.

The FDA’s approval follows a National Institutes of Health (NIH) study that randomly selected 82 participants and studied the impact of one and two months of GATTEX. The study’s 18 co-authors from the University of California, Davis, where the drug was tested, along with the UCSF and UCSF Benioff Children’s Hospital, described in the report that GATTEX was well-tolerated and produced desired effects, such as decreased impulsivity, improved attention and quicker attentional processing. The study was part of an FDA-approved clinical trial that paid for by Novartis and other funding sources.

Prior to the FDA’s approval, dozens of patients and families had expressed frustration with the FDA for not including an approved study as the basis for approval of the drug.

Parents of children with ADHD have expressed concern for children who will be the primary targets of GATTEX.

This is important because children in intensive care units could suffer adverse effects if they are given GATTEX.

“The product could have more serious side effects including seizures, convulsions, lipids elevations, liver injury, and damage to the bones, kidneys, and lungs,” warned Julie Witkin, mother of two children with ADHD.

After a long fight, the newly-approved medication is now available to adults in the US to treat ADHD.