The drug – QuilliChew ER (methylphenidate hydrochloride) - was cleared for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged six and over last week, based on the positive results of pharmacokinetic and comparative studies.
The tablet was developed by Tris Pharma and NextWave Pharma, which was acquired along with QuilliChew ER by Pfizer in 2012.
It uses Tris’ ORalXR+ technology, which consists of an insoluble polymer film that coats and protects active pharmaceuticals ingredients (APIs) from chewing or other types of mechanical stress.
QuilliChew ER – which Tris will manufacturer at its facility in Monmouth Junction, New Jersey – is the first chewable extended-release formulation approved by the US Food and Drug Administration (FDA).
Pfizer said it intends to launch the product in the US early next year.
Nexiclon XR
Tris will be hoping the drug fares better than the hypertension treatment Nexiclon XR (clonidine), which is the other OralXR+ based product it worked on with NextWave.
The drug that would go on to become Nexiclon was cleared by the FDA in December 2009 in two dosage forms: an extended-release tablet; and an extended-release suspension.
Tris licensed the drugs to NextWave and the firms launched them as Nexiclon XR in the US in 2011.
However, the drug was only on the market for a short time before NextWave handed it back to Tris.
According to Torreya Insights' AVARX database of pharmaceutical products, the drug is not currently on the market and Tris is looking for partners.