SUDA’s ondansetron project is a first-in-class mint-flavoured oral spray formulation of ondansetron (marketed in tablet form by GlaxoSmithKline under the brand name Zofran®), the most commonly prescribed antiemetic to treat nausea and vomiting induced by chemotherapy or radiotherapy and also other post-operative settings.
This project achieves therapeutic drug levels by delivering a micro-mist of concentrated ondansetron over the oral mucosa and may offer a desirable alternative to patients requiring antiemetic therapy who have difficulty in swallowing.
SUDA has undertaken a Pivotal PK Clinical Study. A summary of the study highlighted:
- Rapidly absorbed via oral mucosa with detectable plasma levels immediately following administration
- Demonstrated bioequivalence with Zofran®
- Superior rate of absorption within the first 20 minutes
- Well tolerated with no signs of oral irritation