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Cipher Pharmaceuticals Launches New Prescription Drug for Oral Cold Sores

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Posted: September 18, 2015
Edited by Dentaltown staff

CHARLESTON, S.C.—Cipher Pharmaceuticals has introduced a new product, Sitavig (ACYCLOVIR) 50mg Buccal Tablets, to the dental community for the treatment of herpes labialis caused by the HSV-1 virus.

Sitavig (50 mg 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 Lauriad delivery technology which consists of a tablet that sticks to the gum above the canine tooth on the side of the lip that is infected with a cold sore.

Eight mm in diameter and 2.2–2.6 mm in thickness, this white-to-slightly-yellow tablet is tasteless and odorless. It dissolves gradually to provide a sustained release of medicine. As a dentist, you are apt to see cold sores on a regular basis and with a recommendation of Sitavig, you now have the option to help your patients with more than their teeth.

A Phase III study¹ demonstrated that a single low dose of Sitavig Acyclovir buccal tablet improved all clinical parameters of labial herpes; in particular, it increased the percentage of blocked lesions and delayed by about 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 labial herpes (HL). However, Acyclovir Lauriad muco-adhesive buccal tablet (Sitavig) is an innovative drug delivery system that provides a high sustained-release local exposure of acyclovir in oral mucosa, supporting its evaluation as single low dose in the treatment of HL. 

“We are very excited to inform the dental community about Sitavig,” said Charles Jenkins, vice president of marketing at Cipher. “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.  This is a very dynamic and extremely proactive approach to a cold sore recurrence, and studies show that when Sitavig is applied at first signs of episodic prodromal symptoms, it can often actually abort the episode entirely. What makes Sitavig extremely user-friendly,” said Jenkins, “is that a patient can eat and drink normally once the tablet adheres to the gum, which is usually within a few minutes.”

Study¹ confirms efficacy
In a multi-center, double blind, placebo-controlled, patient-initiated trial, 775 patients with recurrent HL were randomly assigned to either a single application of Sitavig 50 mg or matching placebo as soon as prodromal symptoms occurred. The primary endpoint was the time to healing (TTH) of primary vesicular lesion (mITT population). Other endpoints included incidence of blocked episodes, duration of herpes episodes, and incidence and time to next recurrence evaluated during a 9-month follow-up (ITT population). 

Results confirm success with treatment modality
With Sitavig 50 mg, the incidence of blocked herpes episodes was increased by a relative rate of 24.2% (34.9% vs 28.1%; p = 0.042), the median duration of herpes episodes was reduced (5.6 days vs 6.4 days, p = 0.003). During the nine-month follow up, recurrence of herpes lesions was less frequent (64.2% vs 73.6%; p = 0.027) and delayed (median 205 days vs 165 days, p = 0.041) in the Sitavig 50mg group. Patients were satisfied by the treatment and adverse events were similar to placebo.

In summary, Sitavig 50 mg provided clinical benefit to patients independently of the lesion stage. It reduced 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 50 mg buccal tablet is an attractive alternative to systemic antiviral treatment for patients with recurrent HL when applied within one hour after the occurrence of prodromal symptoms. 

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.
3Lemarchand C, et al. J Clin Pharmacol & Clin Pharmacokinet. 2014; 1(1):000001.
 
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