Dental News - Forward Science licenses cold sore drug from EPI Health

Dental Tribune USA

Fri. 10 August 2018

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HOUSTON, Texas, USA: Forward Science and EPI Health, a wholly owned subsidiary from EPI Group, have entered into an exclusive agreement licensing Sitavig to Forward Science in the dental market. The U.S. Food and Drug Administration (FDA) approved Sitavig on April 12, 2013. It is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults.

Cold sores, also called fever blisters, are common viral infections that are caused most often by the herpes simplex virus (HSV-1). Cold sores are contagious even if you do not see the sores. Antiviral medications can help cold sores heal more quickly and may reduce how often they return, however there is no cure for HSV infection. The current method of treating cold sores is to alleviate the symptoms, reduce the duration of the outbreak, and reduce the number of outbreaks.

“We are excited to continue to bring advanced products to the dental market that frequently get overlooked,” said Forward Science CEO Robert J. Whitman. “As physicians of the mouth, dentistry has an opportunity to change lives affected from the negative stigma of cold sores, and Sitavig is the best product to do that with.”

The most common treatment method currently used for cold sores is prolonged systemic dosing of acyclovir. Forward Science Chief Technology Officer Brian Pikkula said about the uniqueness of Sitavig for cold sores, “Sitavig’s active drug is also acyclovir, but its proprietary delivery system produces several distinct advantages over the current standard of treatment.”

Sitavig is a single dose, which dramatically increases compliance and ease of use for the patient. More importantly, the local targeting of Sitavig to the oral mucosa provides a marked increase in salivary concentration of the active drug where it is needed, while at the same time giving orders of magnitude lower plasma concentration of acyclovir resulting in reduced side effects. Because of the locally targeted therapy, a third of patients in the clinical trial did not progress to breakout and those with recurrent cold sores experienced a significant delay before their next episode, according to the company.

“Sitavig has predominately been marketed to the dermatology market with much success, said Chuck Jenkins, EPI vice president of commercial operations and strategy, “Forward Science has shown success in launching new products to the dental market, and we are excited to partner with them in efforts to get Sitavig to more patients.”

Sitavig indications

Sitavig (acyclovir), 50mg Muco-Adhesive Buccal Tablet is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults.

Sitavig safety information

Sitavig should not be used in patients with known hypersensitivity to acyclovir, milk protein concentrate, or other components of the product.
Sitavig has not been studied in pregnant women or in immunocompromised patients, and no interaction studies have been performed. Sitavig’s safety and efficacy have not been established in pediatric patients.
Sitavig is a Pregnancy Category B product; therefore, it should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. It is not known if Sitavig is excreted in breast milk; however, systemic absorption is minimal.
In a controlled clinical trial Sitavig’s most common side effects (greater than or equal to 1 percent) were: headache (3 percent), dizziness (1 percent), lethargy (1 percent) ingival (gum) pain (1 percent), aphthous stomatitis (canker sores) (1 percent), application site pain (1 percent), application site irritation (1 percent), erythema (1 percent) and rash (1 percent). In the same trial these side effects ranged from 0-3 percent for placebo.

To report Suspected Adverse Reactions or product complains, contact EPI Health at (813) 671-8570 or FDA at (800) FDA-1088 or www.fda.gov/medwatch.

(Source: EPI Health)