Archives for September 2015

Quick! Think about four things you might need in a moment’s notice….

1. A condom

2. An EpiPen

3. A cold sore treatment

4. An inhaler
For anyone who is allergic to bee stings, or who suffers from asthma, number 2 and number 4 are no-brainers, yet they are too often forgotten! An asthma attack on a crowded subway or all alone in a hotel room can be catastrophic. A condom? It goes without saying! If you don’t have one, you may be seriously out of luck.

But, what about a cold sore treatment? Until very recently, including cold sore treatments on a list of things you might need in a moment’s notice would not have made much sense. But now, a new drug is changing that! An important FDA-approved cold sore drug, with a totally revolutionary technology, can help treat cold sores in several key ways . . . yes, even in a moment’s notice! Sitavig® (ACYCLOVIR), 50mg Buccal Tablet may help abort, shorten the duration, and increase the amount of time between episodes when taken within one to six hours of the prodrome phase. Sitavig® represents a treatment breakthrough in the herpes labialis (HSV-1 cold sore) category, because of its unique vehicle and delivery system.

The thing about Sitavig® is that it should be applied within one to six hours of the “prodrome” phase of a cold sore. This is the time when no lesion is visible, yet anyone who has ever had a cold sore understands it to mean a cold sore is on its way. When applied to the gum above the incisor tooth, Sitavig® can literally help you avoid a flare!!!! Yet, timing is everything. People who know about Sitavig® generally carry one with them at all times to take advantage of the “window of opportunity” offered by this new drug. Packaged in two blister packs, one prescription allows you to immediately treat the oncoming episode while the other can stay packed away in your purse or even your gym bag for the next time you feel that all too familiar tingle on your lips.

Phase III Study Proves it Works!
A Phase III, randomized, double-blind, placebo controlled study1 including 775 subjects demonstrated that a single low dose of Sitavig® acyclovir 50mg buccal tablet improved all clinical parameters of labial herpes when applied shortly after symptoms occurred. Most notably, Sitavig® decreased duration of episode, increased the percentage of blocked lesions, and delayed by 105 days the recurrence of the next herpes episode.2 It is well known that the standard of care, systemic antiviral drugs, are typically prescribed at high doses in the treatment of HL. However, Sitavig®’s innovative drug delivery system that provides a high sustained-release local exposure of acyclovir in the oral mucosa, while having low systemic absorption, supports its evaluation as single low dose in the treatment of HL.

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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 fda.gov/medwatch.com or call 1-800-FDA-1088.
See attached Full Prescribing Information.

1Bieber T, et al. Efficacy and Safety of Acyclovir Mucoadhesive Buccal Tablet in Immunocompetent Patients With Labial Herpes (LIP Trial): A Double-Blind, Placebo-Controlled, Self-Initiated Trial. J Drugs Dermatol. 2014;13(7):791-798. View study (link will lead you to the JDD site).
2SK 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.

About Cipher Pharmaceuticals:
Cipher Pharmaceuticals is a growing specialty company with a focus on dermatology. Our goal is to develop and acquire best-in-class skin care solutions for unmet medical needs. Cipher has everything it takes – strong financials, a robust and growing product portfolio, and savvy executive leadership with proven commercial execution capabilities – to change the face of dermatology treatment for patients and healthcare professionals throughout North America. cipherpharma.com