Forward Science Licenses Cold Sore Drug Sitavig® from EPI Health
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", shares 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 shares 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 patients in the clinical trial did not progress to break out and those with recurrent cold sores experienced a significant delay before their next episode.
"Sitavig has predominately been marketed to the dermatology market with much success, shares Chuck Jenkins, EPI VP 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® (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%) were: headache (3%), dizziness (1%), lethargy (1%), gingival (gum) pain (1%), aphthous stomatitis (canker sores) (1%), application site pain (1%), application site irritation (1%), erythema (1%) and rash (1%). In the same trial these side effects ranged from 0%-3% for placebo.
To report Suspected Adverse Reactions or product complains, contact EPI Health at 1-813-671-8570 or FDA at 1-800-FDA-1088 or www.fda.gov/
About EPI Health
Headquartered in Charleston, South Carolina, EPI Health is a specialty pharmaceutical company focused on acquiring, developing and marketing prescription medical dermatological products. EPI Health is a wholly owned subsidiary of EPI Group. EPI Group is a privately held company headquartered in Charleston, South Carolina with over 2,000 employees. The Company's diverse portfolio includes: Evening Post Publishing, which has seventeen publications in the state of South Carolina including the 2015 Pulitzer Prize-winning Post and Courier; Cordillera Communications, a network of 11 broadcast television stations covering 2.3 million households; Heart of Hospice, a hospice provider operating multiple locations across Louisiana, Mississippi and Arkansas; and Clear Night Group, a digital marketing agency based in Minnesota.
About Forward Science
Forward Science is a privately held biotechnology company based in Houston, Texas. OralID, Forward Science's flagship product, is an award winning oral cancer screening device that allows clinicians to discover abnormalities that may not be seen under traditional white light examinations. With the success of OralID, Forward Science continued to focus on moving science forward in the oral healthcare industry by launching advanced diagnostic testing products (CytID, hpvID, phID, PathID) along with treatment options (SalivaMAX and SalivaCAINE)
To learn more about Sitavig, or any of Forward Science's products, please visit https://www.ForwardScience.com or call 855-696-7254.