FDA approves Zuplenz oral soluble film
Developed by Strativa Pharmaceuticals for cancer patients
The US Food and Drug Administration (FDA) has approved Strativa Pharmaceuticals’ Zuplenz (ondansetron) oral soluble film for the prevention of post-operative, chemotherapy induced, and radiotherapy induced nausea and vomiting. Zuplenz, a unique formulation of ondansetron, is the first oral soluble film approved by the FDA as a prescription medicine.
The FDA granted approval based on clinical study data comparing the bioequivalence of Zuplenz 8mg with Zofran ODT (orally dissolving tablet) 8mg. The pharmacokinetic results of these studies demonstrated that a single dose of Zuplenz, taken with or without water and under fed and fasting conditions, was comparable with Zofran ODT.
John MacPhee, president of Strativa Pharmaceuticals, a division of Par Pharmaceutical Companies in the US, said the FDA approval was ‘an important milestone’ for Strativa as it ‘reinforces our commitment to enhancing prescription products to meet the different needs of patients’.
Zuplenz uses Monosol RX’s PharmFilm oral soluble film technology to dissolve rapidly on the tongue without the need for water, which can cause additional discomfort for some patients suffering from nausea and vomiting. Zuplenz will be offered in 4mg and 8mg dosage strengths, and is expected to be available in pharmacies in the third quarter.
Strativa and MonoSol Rx entered into an exclusive licensing agreement two years ago under which Strativa acquired the US commercialisation rights to Zuplenz oral soluble film. Under the terms of the amended agreement, the FDA approval triggered Strativa's payments to MonoSol Rx of a US$4.0m approval milestone and a US$2.0m pre-launch milestone.