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Please Note: The technology listed below is not available to the public at this time. This technology is in the early stage of research and requires further development before it is ready for the marketplace. The VA is currently in the process of identifying potential companies who may be interested in licensing and/or further developing the technology through Cooperative Research and Development Agreements (CRADA). Through cooperative research initiatives such as these, it is our hope and goal that commercial products will be fully developed and made available to benefit veterans and others.  

VA TECHNOLOGY OPPORTUNITY BRIEF

Solution Containing Nicotine

(#01-094)

OPPORTUNITY: 
The Department of Veterans Affairs (VA) is seeking a commercial partner for a non-exclusive license and/or further develop this technology through a Cooperative R&D Agreement (CRADA) to expedite bringing it to market.

BACKGROUND: 
Annual cigarette consumption in the US is on a steady decline. Annual consumption was 2.5 billion in 1900, and peaked at 640 billion in 1981. Consumption was estimated at 422 billion in 2001. The US market for smoking cessation products in 2000 was $812 million. The smoking cessation market has been transformed, shifting from a retail emphasis to a more medical approach.
According to the Centers for Disease Control and Prevention (CDC), an estimated 1.6 million elementary-school-aged children have been diagnosed with attention deficit disorder (ADD). The US market for ADD treatments in 2001 was approximately $3.9 billion (PR Newswire 2002).
Approximately 4 million Americans have Alzheimer’s disease (AD), with that number expected to increase to 14 million by 2050 unless a cure is found. Worldwide, the number of those afflicted with the disease is placed at 12 million, a number projected to reach 22 million by 2025. There is no known cure for the disease; treatment aims at relief from the symptoms. The federal government estimates spending approximately $466 million for Alzheimer's disease research in 2000, while the Alzheimer’s Association has granted more than $82 million in research grants to date (Pro Health, Inc. 2002). The US market for AD drugs in 2001 was estimated at 1.3 percent of the total central nervous system (CNS) market and was valued at $606 million. The AD market is one of the fastest growing CNS drug markets, second only to that for multiple sclerosis, and it is projected to be worth $2.4 billion by 2007.

TECHNOLOGY OVERVIEW: 
The subject technology is a method and product for delivering nicotine in a solution form suitable for oral administration. The invention concerns a therapeutic formula to treat various medical conditions, such as to give relief from the craving for tobacco smoking, to treat and alleviate symptoms of attention deficit disorder (ADD), and/or to treat and alleviate the symptoms of Alzheimer's disease (AD).
The existing nicotine delivery systems available on the market in the form of products or patents include gum, transdermal patch, inhaler spray, and salts for retention enemas. The novelty of the subject technology is its ability to deliver nicotine in a palatable solution form for oral administration. (Nicotine in its normal aqueous form is acrid, burning, and bitter in taste.) Also, it can be used in any aqueous solution such as water, beer, wine, or whiskey, milk, soda, or juice; other solvents may be employed as long as they are acceptable for human ingestion and dissolve the nicotine.

TECHNICAL MERIT: 
The invention allows a therapeutically significant dosage of nicotine to be delivered in a beverage without excessive bitter taste. It is thought that nicotine delivery by beverage may be both more effective and more pleasing than other delivery methods. Per the patent’s Summary and Objects of the Invention, a further advantage of the present invention is to provide an acceptable level of nicotine-related sensory stimulation in the throat that may be important in reducing craving for cigarettes. Also, by ensuring liquid intake along with nicotine, the local concentration of nicotine in the upper gastrointestinal tract can be regulated to lessen the likelihood of cramping due to high local concentrations of nicotine, such as from swallowing a capsule.

 

PATENT STATUS:
A US patent was issued on April 3, 2001 (6,686,336)
Federal register: January 21, 2003 (Vol. 68, No. 13) p. 2816

FOR MORE INFORMATION CONTACT:
Saleem Sheredos
Program Manager
Technology Transfer Program
Veterans Affairs
Office of Research & Development (12TT)
5th Floor
103 South Gay Street
Baltimore, MD 21202
202-380-5080
Fax 410.962.2141
e-mail: saleem.sheredos@va.gov

Last Updated - May 17, 2006