PIPELINE PREVIEWS

August 2012 | Volume 11 | Issue 8 | Feature | 1009 | Copyright © 2012

Abstract

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.

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Dermablend Professional
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 Opioid Medications
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-

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