Pipeline Previews

August 2014 | Volume 13 | Issue 8 | Features | 996 | Copyright © August 2014


Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.


Innocutis Holdings LLC has announced the introduction into the North American markets of Sitavig® (ACYCLOVIR) 50mg Buccal Tablets, licensed from BioAlliance Pharma.
Sitavig (50 mg acyclovir) Muco-Adhesive Buccal Tablet uses a proprietary Lauriad delivery technology, which consists of a tasteless and odorless tablet that sticks to the gum, above the canine tooth on the side of the lip that is infected with a cold sore. The 8mm in diameter and 2.2–2.6mm thick tablet dissolves to provide a sustained release of medicine. Sitavig also requires application to the gum only once-per-episode. A patient can eat and drink normally once the tablet adheres to the gum, typically within a few minutes of application. Moreover, Innocutis reports that when Sitavig is applied at first signs of episodic prodromal symptoms, it can often actually abort the episode entirely.
Innocutis cites a Phase III study to demonstrate that a single low dose of Sitavig® Acyclovir buccal tablet improved all clinical parameters of labial herpes, in particular, it increased the percentages of blocked lesions and delayed by about 100 days the recurrence of the next herpes episodes. Because Sitavig provides a high sustained-release local exposure of acyclovir in oral mucosa, it is evaluated as a single low dose treatment.
In a multicenter 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 followup (ITT population).
With Sitavig 50 mg, the incidence of blocked herpes episodes was increased by 24.2% (34.9% vs 28.1%; P = 0.042), the median PA3 duration of herpes episodes was reduced (5.6 days vs 6.4 days, P = 0.003) as well as viral load in saliva. During the 9-month follow up, recurrence of herpes lesions was less frequent (64.2% vs 73.6%; P = 0.027) and delayed (205 days vs 165 days, P = 0.041) in the Sitavig 50mg.
In this trial, a single administration of a low dose of acyclovir using Sitavig 50 mg resulted in the prevention of vesicular lesions. Consistently, the number and percentage of patients with “non-primary” (outside the lips) vesicular lesions were significantly lower in the Sitavig 50 mg (10.4%) than in the placebo group (15.7%). The study showed that Sitavig 50 mg reduces by 22.7% the risk to experience a recurrence in a 9-month follow up. In addition, the next recurrence of herpes episode was delayed by a mean of 100 days in patients whose herpes lesions recurred.

FDA Approves Jublia for Treatment of Onychomycosis

Valeant Pharmaceuticals has announced FDA approval of its New Drug Application for Jublia (efinaconazole 10% topical solution), the first topical triazole approved for the treatment of onychomycosis of the toenails. Jublia is a solution applied daily to the nail with a flow-through brush applicator built in to the bottle. It dries quickly and there is no need to remove excess product. There are no concerns for systemic side effects such as drug-drug interactions or acute liver injury.
The two positive pivotal studies that were the basis for approval were published last year in the Journal of the American Academy of Dermatology. These international studies were conducted in 1,655 subjects with onychomycosis, including subjects in Canada. For the pivotal studies, the primary endpoint was complete cure at Week 52, which required that the target nail show no clinical involvement and no evidence of fungus present by both KOH testing and a negative fungal culture. In Study 1, 17.8% of subjects treated with Jublia were completely cured, compared to only 3.3% of subjects treated with vehicle. In Study 2, 15.2% of subjects treated with Jublia ® were completely cured, compared to only 5.5% of subjects treated with vehicle. Adverse events that were reported were generally mild and transient and were similar between

FDA Clears Restylane

Valeant Pharmaceuticals has announced that that the FD has issued marketing clearance for Restylane® Silk Injectable Gel with 0.3% Lidocaine, a device indicated for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21. Restylane® Silk