NovaDel’s core technology utilizes a proprietary Oral Transmucosal Spray system to deliver a broad range of marketed drugs through the highly absorptive lining of the mouth into the systemic blood circulation.  Oral sprays may provide substantial benefits compared to other modes of drug administration including:

• Faster onset of action
• Improved dosage reliability
• Improved safety profile
• Enhanced patient compliance and convenience
• Avoiding the need to swallow
• Allowing medication to be taken without water
• Increased bioavailability of drug by avoiding metabolism by liver
  
  
  

The designation Oral Transmucosal Spray describes the delivery of liquid formulations of pharmaceutical product to the oral cavity in the form of a mist that covers the oral mucosal membranes.  The oral mucosa is richly supplied with blood vessels and the mucosal membrane is relatively permeable.  As a result, contact with these surfaces enables rapid drug absorption into the systemic circulation. 

Oral Transmucosal Spray formulations reach the systemic circulation through different sites within the oral mucosal cavity:

• Sublingual (through the mucosal membranes lining the floor of the mouth)
• Buccal (via the mucosal membranes lining the cheeks) and
• Gingival (via the hard palate and especially through the junction between the gums and teeth).

There are many advantages to using an oral spray drug delivery system, the most important of which is the rapid delivery of therapeutic levels of a desired drug.  This method of delivery provides direct access to the systemic circulation, bypassing the harsh environment of the stomach and avoiding the extensive metabolism associated with the first circulatory pass through the liver.  Drug delivery via the oral mucosa can also minimize dose variation related to gastrointestinal tract motility, stomach emptying time, food effects, tablet/capsule disintegration and dissolution and enzymatic or chemical degradation in the gut.  Due to decreased degradation and higher absorption, oral sprays often permit a lower dosage of the active ingredient compared with tablet formulations of the same drug reducing the risk of adverse drug reactions.  In many cases, including treatments for patients with difficulty swallowing or nausea, oral spray administration provides enhanced convenience resulting in greater compliance.

NovaDel performs all formulation development and optimization, including stability testing, which applies analytical methods specifically developed in-house for each drug.  The Company’s capabilities include designing and managing the clinical trials necessary to support registration of the product candidates or, alternatively, providing clinical materials for trials administered by NovaDel’s licensing partners.

NovaDel’s system is compatible with, and patented for, use in either pump (air-activated) or aerosol (propellant-driven) sprays, and can be provided in either multi-dose or unit containers based on the medical need and marketing requirements of each product.