October 2014 | Volume 13 | Issue 10 | Features | 1293 | Copyright © October 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.
Inocutis introduces NEW breakthrough
TREATMENT FOR COLD SORES
Sitavig® 50mg (Acyclovir) Muco-Adhesive Buccal Tablet
If you have never experienced a cold sore, consider yourself
lucky! Millions of people get more than one episode per year
and for up to two weeks that the sore may last, virtually everyone
is “watching your lips!” And, not in a good way.
Now, there is a breakthrough treatment for cold sores with the
potential to abort, shorten the duration, increase the amount
of time between episodes. South Carolina-based, Innocutis, is
pleased to announce the introduction of Sitavig® (ACYCLOVIR),
50mg Buccal Tablet. Sitavig represents a treatment breakthrough
in the herpes labialis (HSV-1 cold sore) category,
because of its unique vehicle and delivery system.
Sitavig uses a proprietary delivery technology called Luriad®
which consists of a tablet that sticks to the gum above the incisor
tooth on the side of the lip that is infected with a cold sore.
8mm in diameter and 2.2 – 2.6 mm in thickness, this white-toslightly-
yellow tablet is tasteless and odorless. It dissolves to
provide a sustained release of medicine. It is available by prescription
only at local retail pharmacies.
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 buccal tablet improved all clinical
parameters of labial herpes when applied shortly after
symptoms occurred. Most notable, Sitavig decreased duration
of episode, increased the percentages of blocked lesions
and delayed by 105 days the recurrence of the next herpes
episodes.2 It is well known that the standard of care, systemic
antiviral drugs, is typically prescribed at high doses in the
treatment of labial herpes (HL). However, Sitavig's innovative
drug delivery system that provides a high sustained-release
local exposure of acyclovir in the oral mucosa, supporting its
evaluation as single low dose in HL.
“We are very excited to bring Sitavig to the North American
markets,” said Charles Jenkins, Vice President of Marketing for
Innocutis. “Up to ninety percent of Americans have been exposed
to HSV-1 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.”
If there is anything good to be said about cold sores it is that
they often come with a warning; a tingling or burning sensation
before anything is visible on the lips. This “warning” stage is
called prodrome and when Sitavig was applied within one hour
after prodrome. It provided clinical benefit to cold sore sufferers,
reducing 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,
making Sitavig an attractive alternative option to systemic
antiviral treatment for individuals with recurrent cold sores when
applied within one hour after the onset of prodromal symptoms.
The Promius Promise Physician Portal
To help physicians who would like to better be able to follow
a patient's progress while taking Promius Pharma's generic
isotretinoin, Zenatane™(isotretinoin capsules USP) AB rated
to Accutane, the company has created a web-based provider
portal. It was designed to allow any authorized prescriber
using the Promius Promise, to obtain easy, instant access to
secure patient data related to their prescriptions handled by
the Promius Promise.
The HIPAA secured web portal includes a list of all patients
who are enrolled in the Promius Promise program (when
processed through Direct Success Pharmacy), patient demographics,
dates of prescriptions received and prescription
shipments, information on pending prescriptions, reports
showing communication with the patients and HCP office to
allow the patient to receive isotretinoin within the iPledge® Do
Not Dispense window, and a messaging tool allowing HCP office
to send questions and receive responses within the portal
itself or on their smart phone devices as preferred.
Aqua Pharmaceuticals, LLC Announces FDA Approval
of ACTICLATE™ Tablets
Aqua Pharmaceuticals, an Almirall company, announced ACTICLATE
™, a tetracycline-class antibacterial indicated for the
treatment of a number of infections, including adjunctive therapy
in severe acne, is FDA-approved as 150 mg and 75 mg tablets.
ACTICLATE™ 150 mg tablets have two functional scores,
providing several dosing options to physicians and patients.
The ACTICLATE™ film-coated, round 75 mg tablets and ovalshaped,
dual-scored 150 mg tablets are designed to be small
and easy to swallow. Utilization of the latest manufacturing
technology has allowed 150 mg of doxycycline to be formulated
in a substantially reduced tablet size for ACTICLATE™.