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Zensana, Ondansetron Oral Spray, Enters Pivotal Trials

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.

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