The Science Behind Sitavig

The convenient, discrete choice.


 

Benefits of Sitavig:

  • No pill to swallow
  • Invisible to others
  • Ideal for cosmetic- and appearance-conscious patients with recurrent herpes labialis
  • Treatment does not interfere with most daily life activities
  • One-time dose
  • Second tablet provided in every prescription as backup or for a future outbreak
  • Patients generally know their triggers, and should keep Sitavig available to them especially during these times
HSV-1 Viral Replication

Where HSV-1 replication takes place

  • HSV-1 begins to replicate in the basal layer of the oral mucosa.
  • Patient may experience an itching, burning or tingling sensation.
  • A lesion may form in 2-3 days.
Targeted Delivery

Lauriad™ delivery system¹

  • Muco-Adhesive Buccal Tablet applied to the upper gum over the canine fossa
  • Targeted delivery of antiviral drug directly to the site of viral replication
Sitavig Acyclovir Concentration

Stays active during viral replication¹

  • Specifically designed to slowly dissolve over 12-14 hours
  • Covers the window of maximum viral replication
  • Provides continuous, targeted delivery of acyclovir

Sitavig reduces salivary viral load2

A single dose of Sitavig reduced the viral load in the saliva 5-fold at the site of viral replication (P=.583), possibly reducing the amount of virus available to return into latency.

Days Between Episodes

More days between outbreaks3*

Patients treated with Sitavig had a average of 105 more days before experiencing a recurrent episode of herpes labialis compared to patients treated with placebo. Plus, 36% of patients remained free from lesion recurrence at 10 months post-treatment compared to 26% of placebo patients (P=.027).

Aborted Episodes

Sitavig patients experienced 35% aborted episodes3

34.9% of patients failed to develop a vesicular lesion when applying Sitavig soon after feeling an oncoming cold sore sensation.
 

86% of patients were satisfied with Sitavig treatment²

Disclaimer
*Data on the incidence and delay of the next recurrence need further confirmation as they were obtained on a subset of patients.

 
References

  1. Lemarchand C, Singlas E, Constantini D, Dufour A and Attali P. Plasma, saliva and labial mucosa pharmacokinetics of acyclovir Lauriad mucoadhesive buccal tablet in healthy volunteers. J Clin Pharmacol Clin Pharmacokinet. 2014;1(1):1-9.
  2. Data on file. Cipher Pharmaceuticals.
  3. Bieber T, Chosidow O, Bodsworth N, Tyring S, Hercogova J, Bloch M, Davis M, Lewis M, Boutolleau D, Attali P and the LIP Study Group. Efficacy and safety of acyclovir mucoadhesive buccal tablet in immunocompetent patients with labial herpes (LIP): 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).
Indication & Important Safety Information
INDICATION
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 (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.
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. Click here for Full Prescribing Information.