FDA approves Purixan liquid formulation for ALL- Rare Disease Therapeutics
Rare Disease Therapeutics, Inc. the producer of orphan pharmaceuticals for the treatment of rare diseases, announced that they have received FDA approval for Purixan (mercaptopurine) 20 mg/mL oral suspension---a new, easier-to-dose, liquid form of an established treatment for patients with Acute Lymphoblastic Leukemia (ALL). Unlike the 50 mg tablet form that healthcare professionals often split to provide children with the desired dose, the raspberry-flavoured Purixan liquid enables the measurement of precise doses that can easily be administered to paediatric and adult patients.
The FDA has pointed out that compared to tablets, a suspension offers the advantage of more accurately delivering the desired dose to children with a wide range of weights using a consistent administration schedule. A suspension will allow more flexibility in adjusting the dose and that a commercially produced suspension is more likely to provide a more consistent dose of 6 mercaptopurine than ad hoc compounded formulations.