August 2012 | Volume 11 | Issue 8 | Features | 1009 | Copyright © August 2012
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.
Dermablend has introduced a double action treatment primer
called Skin Perfector Pigment Correcting Primer. This new
product reduces skin pigment imperfections such as age spots,
sunspots, and skin discolorations caused by sun damage, natural
aging, and acne scarring. The product is suitable for all ethnicities
and skin tones. Skin Perfector Pigment Correcting Primer is
a double action formula containing Ceramide White with LHA to
target skin discoloration. The product acts on skin surface layers
to reduce the appearance of excess melanin. It also provides a
micro exfoliation for the removal of unwanted pigmented cells.
Dermablend touts the hydrating ability of the product to lock in
skin moisture and prevent water loss and gentle enough for everyday
use. Finally, Skin Perfector Pigment Correcting Primer is
advertised as fragrance free, suitable for sensitive, and allergic
skin, non sticky, and non greasy. The suggested retail price for
Skin Perfector Pigment Correcting Primer is $45.00 (0.8 fl. oz.).
FDA Approval for Horizant® for Postherpetic Neuralgia
GlaxoSmithKline and XenoPort, Inc. have announced that the FDA
has approved Horizant® (gabapentin enacarbil) Extended-Release
Tablets for the management of postherpetic neuralgia (PHN) in adults.
The efficacy and safety of Horizant for the management of PHN
was evaluated in a 12-week principal efficacy trial, plus two supportive
studies that all met their respective primary endpoints.
The three clinical studies involved 574 adult patients from the
US, Canada and Germany.
The recommended dosage for the management of PHN in
adults is 600 mg twice daily. Treatment should be initiated at a
dose of 600 mg in the morning for three days followed by 600
mg twice daily (1,200 mg/day), beginning on day four. Doses
must be adjusted in patients with impaired renal function. In
the 12-week, controlled study in patients with PHN, somnolence
and dizziness were the most frequently reported side effects.
Horizant causes significant driving impairment. Patients
should not drive or operate other complex machinery until
they have sufficient experience on Horizant to know whether
their ability to perform these tasks is impaired.
Horizant is not interchangeable with other gabapentin products
due to differing pharmacokinetic profiles. The same dose of
Horizant results in different plasma concentrations of gabapentin
relative to other gabapentin products. The safety and effectiveness
of Horizant in patients with epilepsy have not been studied.
Horizant is a prodrug of gabapentin, an antiepileptic drug,
which increases the risk of suicidal thoughts or behavior in
patients who take these drugs for any indication.
To discontinue Horizant in patients with PHN receiving Horizant
twice daily, reduce the dose to once daily for one week prior to
discontinuation to minimize potential for withdrawal seizure.
FDA Approval and Launch of Clindamycin Phosphate
and Benzoyl Peroxide 1.2%/5% Gel
Perrigo Company has announced that it has received final
approval from the FDA for its abbreviated new drug application
(ANDA) for clindamycin phosphate and benzoyl peroxide
1.2%/5% topical gel, the generic equivalent of Duac® Gel. Perrigo
may be entitled to 180 days of marketing exclusivity and
the FDA has deferred determining Perrigo's exclusivity period
until there is another ANDA in condition for approval. Perrigo
has commenced shipment of the product.
FDA Safety for Extended-release and Long-acting
The FDA has approved a risk evaluation and mitigation strategy
(REMS) for extended-release (ER) and long-acting (LA)
opioids, highly potent drugs approved for moderate to severe,
persistent pain that requires treatment for an extended period.
The REMS is part of a federal initiative to address the prescription
drug abuse, misuse, and overdose epidemic. The REMS
introduces new safety measures designed to reduce risks and
improve the safe use of ER/LA opioids, while ensuring access
to needed medications for patients in pain.
Under the new REMS, companies will be required to make
education programs available to prescribers based on an FDA
Blueprint. The REMS also will require companies to make
available FDA-approved patient education materials on the
safe use of these drugs. The companies will be required to
perform periodic assessments of the implementation of the
REMS and the success of the program in meeting its goals.
The FDA will review these assessments and may require additional
elements to achieve the goals of the program.
The ER/LA opioid analgesics REMS include training for prescribers.
Based on an FDA Blueprint, developed with input
from stakeholders, educational programs for prescribers of ER/
LA opioids will include information on weighing the risks and
benefits of opioid therapy, choosing patients appropriately,
managing and monitoring patients, and counseling patients
on the safe use of these drugs. In addition, the education will
include information on how to recognize evidence of, and the
potential for, opioid misuse, abuse, and addiction, and general
and specific drug information for ER/LA opioid analgesics.
The REMS also mandate an updated medication guide and
patient counseling document. These materials contain con-