NovaDel develops formulations using its proprietary system, NovaMist, to realise the benefits of delivery via an oral spray. NovaMist formulations of treatments for insomnia and angina have been approved and NovaDel is now looking to move into the erectile dysfunction market.
An oral spray formulation of sildenafil citrate could have a faster onset of action, lower dose requirements and improve patient compliance and convenience compared to other dosage forms.
Potential benefits of administration via an oral spray are realised because the treatment enters the bloodstream through sites in the oral mucosal cavity. This area has a high concentration of blood vessels and a relatively permeable membrane, resulting in fast absorption.
To further development NovaDel performed a pilot pharmacokinetic (PK) study comparing its product, Duromist, to the tablet formulation of sildenafil citrate, marketed by Pfizer as Viagra.
Results from the 24-person study show 20mg, or two sprays, of Duromist is equivalent, in terms of systemic exposure (AUC0-inf), to a 25mg Viagra tablet. Mean AUC0-inf for 30mg of Duromist was 40 per cent higher than for 25mg of Viagra.
No adverse events were reported and there was no evidence of oral irritation after administration of up to three doses of Duromist. Furthermore, vital signs were within normal range and no changes in electrocardiograms were observed.
Next step
NovaDel and the US Food and Drug Administration (FDA) are now reviewing the results of the study. This will help define clinical trial requirements as a pathway to new drug application (NDA) approval.
“This initial clinical study provides NovaDel with a solid foundation for our future clinical development efforts”, said Steven Ratoff, chairman of the board, president and CEO at NovaDel.