Zensana, Ondansetron Oral Spray, Enters Pivotal Trials

SOUTH SAN FRANCISCO, California—Hana Biosciences has received FDA clearance for its Investigational New Drug Application for Zensana (ondansetron oral spray) to prevent chemotherapy-induced nausea and vomiting. In a press release, Hana said it is initiating a series of pivotal pharmacokinetic trials, including comparison of Zensana with ondansetron tablets (Zofran). Zensana is the first multidose oral spray 5-HT3 antagonist. Patients experiencing nausea and vomiting have difficulty swallowing and holding down pills. Zensana delivers full doses of ondansetron. In addition, drug delivery via a spray to the oral mucosa avoids degradation in the gastrointestinal tract and metabolism by liver enzymes.