Cold Sores
Painful, unsightly and highly contagious, cold sores can be a significant problem for the people they afflict and in severe cases they can affect the sufferer’s ability to eat and talk. Cold sores are physically painful and have social and emotional consequences, since the patient is likely to be stigmatized by visible lesions. Sufferers complain of self-consciousness and a loss of self-esteem, to the point that some stay home from work. Cold sores can be socially humiliating for sufferers since they are both unattractive and easily spread.
Cold sores are caused by the Herpes Simplex Virus 1, which can remain dormant in the body for long periods of time. Typically appearing as small lesions on the lips or surrounding skin, cold sores initially form as clusters of tiny blisters that burst and ultimately crust over. Lasting from approximately 6 to 10 days, they are painful to the touch. The initial HSV-1 infection manifests itself as a flu-like illness and generally occurs in early childhood, although some individuals may contract a primary infection in adulthood. The virus is generally spread through contact with the fluid from the cold sore blisters or with the saliva of an infected individual. Furthermore, the virus is most easily transmitted when the blisters have first formed, but the lesions remain contagious until they have healed completely.
After the initial infection, some individuals may develop an effective immunity to HSV-1. However, for an estimated 45 to 80% of infected individuals, the virus will remain latent in the nerve cells and can be re-activated by triggers such as stress, fever, sunlight, trauma and infection by another pathogen or hormonal fluctuations, which result in the eruption of a cold sore lesion. For 20 to 40% of the population, these distressing outbreaks are recurrent. In recurrent cases, the appearance of lesions is preceded by prodromal symptoms of tingling, itching or burning around the lips. These onset symptoms usually occur 4 to 48 hours prior to the eruption of a lesion, giving the sufferer advanced warning and providing a window of opportunity for preventative therapy.
Extensive scientific research exists on the prevalence and occurrence of HSV-1 and cold sores within the general population. It is estimated that up to 80% of the population of the United States will be infected with HSV-1 sometime during their life. It is documented that 20% to 40% of the population will experience recurrent cold sores. Most individuals experience the pain, discomfort and embarrassment of a cold sore two to three times a year, while some may suffer as many as ten outbreaks a year. The average rate of recurrence is approximately four times per year, plus or minus one occurrence.
Currently Available Treatments
As cold sores are viral in origin, there is currently no cure for them. Treatment options up until this time have been quite limited with only partial efficacy, directed at treatment of the symptoms, not prevention. Oral analgesics, such as ASA or acetaminophen, may lessen the discomfort of cold sore lesions, but will effectively do nothing to speed their healing. Pain relief from a cold sore can also be obtained through the direct topical application of local anaesthetic creams such as lidocaine. Again such topical applications focus primarily on the treatment of the pain, not on the speed of healing the lesion or prevention of the outbreak.
One non-prescription, topical medication currently available in the United States is Abreva®, which was launched by GlaxoSmithKline (“GSK”) in October 2000. Abrevaâ is the first and only FDA-approved non-prescription cold sore medicine, whose claims are similar to anti-virals and only shortens healing time. Jenex anticipates the launch of Abrevaâ in the Canadian market sometime in 2005.
The only Canadian product currently available in the market that has been approved as a general treatment for recurrent cold sores is Lipactinâ, a preparation of heparin sodium and zinc sulphate manufactured by Novartis. The product monograph claims that Lipactinâ lessens symptoms and decreases the duration of cold sore outbreaks. Other non-prescription products have been approved in Canada and the United States to soothe cold sore lesions, but they have no preventative or healing benefits.
Several general lip-care products claim, on their labels, to be useful for relieving the symptoms of cold sores, among other uses. These products include Blistexâ (Blistex, Inc.), Antibiotic Cold Sore Ointment (Columbia Laboratories), Carmexâ (Carma Labs, Inc.) and Chapstickâ Medicated Lip Balm (Wyeth). The main therapeutic ingredients in these products are menthol and/or camphor, which help to reduce discomfort, and a variety of emollients to moisten and protect the lesion. Other products, such as Zilactinâ (Zila Pharmaceuticals), Herpecin-Lâ (Chattem Inc.), Viractinâ (Combe Corp.) and Campho-Pheniqueâ (Bayer) claim that they are designed specifically for the treatment of cold sores. These products contain local anaesthetic agents, such as benzocaine, to alleviate pain and burning. These OTC products may aid in relieving the symptoms of cold sores but do not act on the virus itself or alter the course of the outbreak.
A variety of "natural" treatments are also available, none of which have been clinically proven. There is no medical evidence to support the effectiveness of these natural products, yet these products remain a very popular option, despite the lack of supporting clinical evidence.
A relatively new class of prescription drugs, known as anti-virals, are now being used to suppress recurrent cold sore outbreaks. Currently anti-virals are used both in topical and oral forms as a cold sore treatment. However, the treatment of cold sores in otherwise healthy patients has not been, until recently, among the official indications for these drugs, although they have been prescribed "off label" by physicians for some time.
Most anti-viral compounds block the replication processes shared by both the virus and infected host cell. For this reason, they are damaging to healthy cells and can induce drug-resistant viral mutant sub-strains. At present, the most widely used anti-viral drug is acyclovir. Manufactured by GSK and sold under the brand name Zovirax®, GSK recently licensed the product to Biovail Corp. In January 2003, Zovirax® cream was given FDA approval for a shorten duration claim for cold sores. In addition to acyclovir, a number of pharmaceutical companies have developed other anti-viral drugs. GSK, for example, also manufactures another anti-viral agent, valacyclovir, which is marketed under the brand name Valtrexâ. In September 2002, GSK received approval to market Valtrexâ caplets in the United States with a claim of shortening the duration of cold sores. Denavirâ, whose active ingredient is penciclovir, was the first drug in the United States to receive FDA approval in 1996, for a shortened duration claim against cold sores. The anti-viral drug famciclovir, sold under the trade name Famvirâ and manufactured by Novartis, is used primarily to treat genital herpes and shingles.
In May 2003, the first anti-viral medication approved for the indication of the treatment of cold sores in Canada was Valtrexâ. In the United Kingdom, France and South Africa, however, topical acyclovir is sold OTC as a treatment for cold sores. Pharmaceutical companies have applied to have their anti-virals given non-prescription status in Canada, but there has not been any regulatory change as of yet. The delay may reflect regulators' concerns for its potential to increase viral resistance to drug therapies.
While oral anti-viral therapy may help reduce lesions, it is an expensive and inconvenient approach to the problem. Common side effects of anti-viral drugs include headache, nausea, vomiting, diarrhea and fatigue. These drugs can also harm renal function and, in some cases, cause hallucinations. In addition, the safety of these drugs for pregnant women and young children has not yet been established.
It is evident that millions of individuals’ continue to suffer from cold suffers on a regular basis. The currently available treatments primarily address the problem once the lesion has appeared. Jenex’s interceptCS offers a natural alternative that is clinically proven to be safe and effective in the prevention of cold sores.
Cold Sore Facts
Market Size
“More than 135 million Americans older than the age of 12 are infected with herpes simplex virus type 1, according to a new study presented here at the 38th Interscience Conference on Antimicrobial Agents and Chemotherapy.”
Source: www.slackinc.com
“Roughly 58% of the U.S. population is affected by cold sores, and 24 percent, or 65 million people, suffer from recurrent sores.”
Source: www.zila.com
“Recurrent herpes simplex labialis is a common infection, affecting nearly one-third of the U.S. population.
Source: www.asmusa.org American Society of Microbiology
“One-in-five Americans suffers from cold sores each year. Most experience the pain, discomfort, and embarrassment of a cold sore two-to-three times a year, while some may suffer as many as 10 outbreaks a year.”
Source: Press Release – GSK Jan. 9, 2001
“An estimated 40 million American adults suffer from recurrent cold sores.”
Source: Press Release – GSK March 15, 2001
“It is estimated that up to 80% of the US population will be infected with HSV-1 at sometime in life, and that in up to 40% of the population, the initial infection will be followed by recurrent herpes labialis infections.”
Source: www.utexas.edu/pharmacy
“Herpes simplex virus type 1 causes recurrent herpes labialis, a common disease afflicting up to 40% of adults world wide.”
Source: Antimicrob Agents Chemother Oct. 2000
“a known history of herpes labialis was reported by 39.9 per 100”
Source: Study in France by Societe Francaise de Medecine Generale
“The prevalence of recurrent herpes labialis was 32.9%.
Source: American Journal Epidemiology March 1988
“Roughly 50 million Americans suffer from fever blisters or cold sores with more than 100 million episodes estimated annually.”
Source: www.denavir.com
“80% of the population carry HSV-1, 25% of those are recurrent.”
Source: www.cold-sore.com
“20% to 40% of HSV-1 carriers are recurrent.”
Source: www.webmed.com
Recurrence
“The average rate of recurrences is about four times per year, plus or minus one.”
Source: www.herpes.org a non-profit information & support website managed by the Center for The Study of Life, Inc.
Source: Norwegian Study – Tidsskr Nor Laegeforen April 30, 1991
Points of Interest
“65% of recurrent cold sore sufferers are women.”
Source: www.denavir.com
“Acyclovir …. available on a generic basis, a year’s suppressive therapy need cost only a little more than $100 per year”
Source: www.herpes.org
“It’s possible the FDA will never approve prescription cold-sore treatments for over-the-counter use. In March 2000, the FDA issued a guidance paper advising the pharmaceutical industry that if antiviral agents were approved for over-the-counter sale to treat cold sores, they could be misused, resulting in a resistant strain of the herpes virus.”
Source: Health Journal – Wall Street Journal
“50% of sufferers purchase an O.T.C. preparation, while only 1% to 3% will seek doctor-prescribed agents.”
Source: www.utexas.edu/pharmacy
“50% said they were embarrassed to be seen with a cold sore
51% felt that ‘everyone was looking’ at them
83% said they dread getting cold sores
80% reported they try to avoid kissing loved ones
Source: www.denavir.com
“Sufferers have reported they avoid family and friends during outbreaks. Up to 15% of sufferers have reported staying home from work during an out break.”
Source: www.centerwatch.com
"Prevention is the Solution"
