July 21, 2014 – Charleston, SC — Innocutis is pleased to announce the introduction into the North American markets of Sitavig® (ACYCLOVIR) 50mg Buccal Tablet. Sitavig (50mg acyclovir) Muco-Adhesive Buccal Tablet, represents a treatment breakthrough in the herpes labialis category, because of its unique vehicle and delivery system. Sitavig uses a proprietary delivery technology which consists of a tablet that sticks to the gum above the incisor tooth on the side of the lip that is infected with a cold sore. 8mm in diameter and 2.2 – 2.6 mm in thickness, this white-to-slightly-yellow tablet is tasteless and odorless. It dissolves to provide a sustained release of medicine.
A Phase III, randomized, double-blind, placebo controlled study¹, including 775 subjects demonstrated that a single low dose of Sitavig acyclovir buccal tablet improved all clinical parameters of labial herpes when applied shortly after symptoms occurred. Most notable, Sitavig decreased duration of episode, increased the percentages of blocked lesions and delayed by 105 days the recurrence of the next herpes episodes.² It is well known that the standard of care, systemic antiviral drugs, are typically prescribed at high doses in the treatment of labial herpes (HL). However, acyclovir muco-adhesive buccal tablet (Sitavig) is an innovative drug delivery system that provides a high sustained-release local exposure of acyclovir in the oral mucosa, supporting its evaluation as single low dose in HL.
“We are very excited to bring Sitavig to the North American markets,” said Charles Jenkins, Vice President of Marketing for Innocutis. “up to ninety percent of Americans have been exposed to HSV by the time they are 50, but there hasn’t been a real breakthrough product to address this problem in many years. Sitavig is revolutionary because unlike systemic drugs and topical prescription creams, Sitavig requires application to the gum only once-per-episode.” Charles adds, “Sitavig is by prescription only and is available at your local retail pharmacy.”
Sitavig 50mg provided clinical benefit to patients, reducing the occurrence of vesicular lesions, primary or non-primary, which is the most important burden of the disease. It also prevented and delayed the recurrence of the next herpes episode. Therefore, Sitavig 50mg buccal tablet is an attractive alternative option to systemic antiviral treatment for patients with recurrent HL when applied within 1 hour after the occurrence of prodromal symptoms.
Sitavig® (acyclovir), 50mg Muco-Adhesive Buccal Tablet is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults.
IMPORTANT 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 pain (1%), aphthous stomatitis (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.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch.com or call 1-800-FDA-1088.
See Full Prescribing Information Full Report.
1- Efficacy and safety of acyclovir Lauriad® mucoadhesive buccal tablet in immunocompetent patients with labial herpes (LIP trial): a double-blind placebo-controlled self-initiated trial.
2- SK Tyring, el al., a single application of acyclovir mucoadhesive buccal tablet reduces recurrence of herpes labialis in a randomized double-blind phase 3 study: Exploratory results, Journal of Investigative Dermatology. May 2014. Volume 134, supplement 1: s91
INNOCUTIS is a pharmaceutical company specializing in the development and commercialization of therapies focused on medical treatment of dermatological conditions. INNOCUTIS’ current portfolio of products consists of established branded prescriptions. At INNOCUTIS we believe our focus on medical dermatology sets us apart as a company that understands the growing needs of the dermatology specialty. Our commitment is to be “best-in-class” in skin-related therapies, providing clinicians with improved solutions for the management of daily challenges experienced in their practice. Our “search and development” efforts are designed to identify and acquire late-stage and/or marketed proprietary pharmaceutical products for the treatment of dermatological diseases that have an existing base of safety and efficacy data.
For more information, visit the Innocutis Holdings, LLC web site.
US Media Contact:
The Lane Communications Group, Inc.
Innocutis Holdings, LLC
Vice President – Marketing
T: 843-965-8333, ext. 107