Zensana™
Zensana™ (ondansetron HCl oral spray) contains the most widely prescribed anti-emetic compound, ondansetron, for chemotherapy/radiotherapy induced nausea/vomiting (CINV/RINV).  It has the potential to be a more convenient alternative to the tablet, intravenous and suppository forms of the drug, which are marketed by GlaxoSmithKline under the brand name Zofran®.
Zensana™ would be the first oral spray 5-HT3 antagonist that conveniently delivers full metered doses of ondansetron, potentially allowing patients to gain and maintain protection from chemotherapy-, radiation- and post-operatively induced nausea and vomiting more rapidly than the tablet formulation.  Many patients receiving chemo- and radiation therapy have difficulty swallowing and are potentially unable to tolerate other therapies, known as anti-emetics, which are intended to prevent nausea and vomiting. The convenience of drug delivery via an oral spray may be a desirable alternative to tablets and other forms of ondansetron for patients suffering from severe nausea and vomiting.

The potential benefit of Zensana™ is not having to take a tablet with water in patients suffering from nausea and vomiting where a solid dose or water could induce nausea/vomiting.

Clinical Studies

Definitive pharmacokinetic studies are in progress with the expectation of an NDA being filed later in 2009.  Clinical studies with a previous formulation of this product demonstrated that Zensana™ is bioequivalent to ondansetron tablets.

Current Status

In August 2007, NovaDel announced a sublicense agreement for Zensana™ with Par Pharmaceuticals from Hana Biosciences.  This sublicense agreement agrants Par the development and commercialization rights to Zensana™ in the U.S. and Canada.  In May 2008, NovaDel announced a partnership with BioAlliance for the development and marketing of this product in Europe.

About CINV/RINV

Nausea/vomiting is the most common morbidity occurring in 60-85% of patients undergoing cancer therapy.  5-HT3 antagonsits are the standard of care for treating CINV/RINV with about $1.5 billion in sales in the United States in 2007.  Ondansetron is the leading 5-HT3 antagonist.