Sitavig
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
