NovaDel Pharma Inc. a specialty pharmaceutical company that develops oral spray formulations of marketed pharmaceutical products, reported opening an original Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) for its lead development program Duromist, its sildenafil oral spray product for the treatment of Erectile Dysfunction (ED).
Treatment of Erectile Dysfunction was a multi-billion dollar global market in 2010. In the United States alone, more than 18 million individuals suffer from ED. The risk of developing ED increases with age. The ageing population and other risk factors like physical inactivity, smoking and high cholesterol are expected to lead to an increase in the number of people with this condition over the next few years.
Sildenafil, in the form of a citrate salt, is a selective inhibitor of cyclic Guanosine Mono-Phosphate (cGMP)-specific phosphodiesterase Type 5 (PDE5). The PDE5 class of drugs dominates the current global market for ED drugs. Sildenafil citrate was approved as a new chemical entity in March 1998 as Viagra (sildenafil citrate) Tablet for the treatment of ED and is owned by Pfizer.
NovaDel Pharma Inc. has developed an oral spray formulation of sildenafil citrate that will be sprayed directly in the mouth over the tongue for the treatment of erectile dysfunction. The Duromist dosage form is a metered spray that is administered orally and offers the potential for increased patient convenience, reduced food effect and lower dose. Earlier this year, NovaDel met with the FDA at a Pre-IND meeting to discuss its clinical plan for the New Drug Application (NDA). FDA has accepted the IND application and the required 30 day review period is now complete.
“The filing of the IND represents an important milestone in the overall development plan for Duromist,” commented Steven B Ratoff, chairman and chief executive officer. “The opening of the IND will allow us to focus on completing the necessary studies and activities to support the NDA filing and approval.”