Since the approval of mercaptopurine in 1953, it has only been available as a 50 mg tablet. For pediatric patients with ALL, the tablet formulation has not been optimal due to difficulty with body surface area dosing and adjustments. A suspension formulation allows for more accurate dosing in pediatric patients with a wide range of weights as well as more flexibility in dose adjustments.
The approval of Purixan was based on one clinical study that assessed the bioequivalence of mercaptopurine from Purinethol tablet (Teva) with that of the mercaptopurine oral suspension in a healthy adult population.
Purixan will be available as a 20 mg/mL oral suspension in 100 mL bottles.