NovaDel has a robust pipeline of drug candidates in all stages of development, with one approved product in the U.S., several product candidates currently under late stage development, and multiple candidates in earlier stages of development and clinical review.

NovaDel’s pipeline is composed entirely of oral spray drug candidates that were generated through the application of the Company’s proprietary oral spray formulation technology to currently approved pharmaceuticals. This technology may enable more rapid delivery of drugs into the bloodstream than the original drug, which results in faster onset of action and potential patient benefits in compliance, convenience and safety.

An additional advantage to NovaDel’s development candidates is the time and cost efficiency resulting from the use of the FDA’s 505(b)(2) regulatory pathway.  This abbreviated regulatory mechanism allows for the use of existing efficacy and safety data contained in the original drug application.  The steps in NovaDel’s drug development process typically involve formulation of the candidate into an oral spray, successful completion of pilot and definitive studies followed by focused safety studies in human subjects.  These highly efficient clinical trials are followed by regulatory submission.  This process may take 3 years compared to the typical 8 to 10 years for development of a new pharmaceutical candidate.  Substantial cost savings may also be realized through NovaDel’s drug development strategy: generally, the development cost for products utilizing the 505(b)(2) pathway is less than $5 million. 

Imitrex®, Zofran® and Requip® are registered trademarks of GlaxoSmithKline. Ambien® is a registered trademark of Sanofi-Aventis. Zanaflex® is a registered trademark of Acordia Therapeutics Inc. ZolpiMist™ and NitroMist™ are trademarks of NovaDel Pharma, Inc. Zensana™ is a pending trademark of Hana Biosciences.