The majority of nasal products currently on the market address local conditions such as treatment of rhinitis and congestion. The nasal route provides a means for achieving rapid drug absorption and onset of therapeutic action, and is particularly advantageous for conditions where fast onset of action is needed. Currently available products in this category include sumatriptan, zolmitriptan, and ergotamine (migraine), and butorphanol (pain).
Other nasal products are available for drugs that are poorly absorbed by other routes of administration and have to otherwise be administered by injection—calcitonin (osteoporosis), nafarelin and buserelin (endometriosis), desmopressin (enuresis), cyanocobalamin (vitamin supplementation), and estradiol (hormone-replacement therapy).
While there is currently only one marketed intranasal vaccine, a live attenuated influenza antigen (FluMist®), many new intranasal drug and vaccine products are in development. The nasal delivery market is expected to continue to expand over the coming years with the arrival of new and improved products.
Although the nose is an attractive drug delivery target, not all therapeutic agents have the desired properties for optimal effect and there is still a need for innovative formulation technologies to enable the delivery of these sub-optimal compounds.
Among these innovations are Archimedes’ ChiSys®, an enabling technology for nasal drug and vaccine delivery that has been shown in preclinical and clinical studies to provide improvements in the intranasal bioavailability of drug compounds ranging from polar small molecules to peptides and proteins, as well as enhancing the immune response to nasal-administered vaccine antigens. Other nasal delivery technologies in development include CPE-215® (CPEX Pharmaceuticals) and Intravail® (Aegis Therapeutics).
Innovative systems are also needed for lipophilic drug compounds such as fentanyl with a short duration of action and/or where rapid and extensive absorption may be associated with undesirable side effects. Archimedes’ PecSys™ technology addresses this need and is currently used in NasalFent®, an intranasal fentanyl spray, which is delivered using a conventional nasal spray pump and forms a thin gel layer when sprayed into the nose, resulting in modulated drug absorption into the systemic circulation and an increased duration of action. NasalFent has successfully completed Phase III clinical trials and is expected to be approved in mid-2010.