FDA Approvals & News
New Topical Rosacea Treatment from Galderma
Galderma Laboratories announced the FDA approval of its new metronidazole 1% gel (MetroGel) for the treatment of the inflammatory lesions of rosacea. The new medication, available by prescription since the end of July, incorporates a higher concentration of metronidazole in a new vehicle.
The new MetroGel 1% uses the HSA-3 vehicle, which is a combination of niacinamide, betadex and propylene glycol. The vehicle is a water-based formulation and contains no alcohol. The new product calls for once-a-day dosing as opposed to twice-a-day dosing for more topical rosacea treatments.

Marketing Approval for Revitalight
Skincare Technology announced that it received a letter from the FDA giving the company permission to market the Revitalight’s Blue Pulsator device for treating moderate inflammatory acne vulgaris (blue light) and pain (red and amber light).
According to Skincare Technology, the Revitalight unit can be used for treatment of moderate inflammatory acne vulgaris (blue pulsator), promoting increased blood flow (red and amber pulsators), facial massage (red and amber pulsators), and relief of pain (red and amber pulsators).
The Revitalight uses a pulsator to project its LED to the skin. The blue light emitting from the device is a combination of 12 blue 420 nm LEDs at 18 mw each and Lambertian blue 455 LED at 100 mw, which results in 45 mw/cm2 or 4.05 J/90 seconds at skin level. According to the company, the system is calibrated to pulsate the light at a multi-frequency to further achieve a greater result, and it is capable of focusing its LED beam to direct all light energy to a specific problem area.

First-Time Generic Approved
The FDA approved first-time generic alclometasone dipropionate 0.05% cream for relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The new generic, manufactured by Altana Inc., is the generic equivalent of Aclovate by GlaxoSmithKline.

New Anesthetic Patch
Zars Inc., has announced the FDA approval of its topical local anesthetic patch, Synera (lidocaine 70 mg and tetracaine 70 mg). The patch is used to numb the skin before various medical procedures, such as superficial venous access, as well as certain dermatological procedures. The product is indicated for use in children and adults.
Synera uses a thin layer of local anesthetic formulation integrated with an oxygen-activated heating element. The heating element, according to Zars, enhances the delivery of the local anesthetics into the skin. The patch begins to heat once removed from the storage pouch.
In clinical trials, the most common side effects were local skin reactions, such as erythema, blanching and edema. Synera is contraindicated in patients with a known history of sensitivity to lidocaine, tetracaine or local anesthetics of the amide or ester type.

Aczone Gel Approved to Treat Acne
The FDA granted final approval to QLT Inc., to market its dapsone 5% gel (Aczone Gel) for topical treatment of acne vulgaris.
Patients using Aczone Gel will need to be screened to detect if they are predisposed to one type of anemia (hemolytic anemia) because of a specific enzyme deficiency, G6PD (Glucose 6-phosphate dehydrogenase) deficiency. If a patients is found to have this deficiency, he or she will have to be monitored with regular blood counts. QLT says it will undertake a post-approval Phase IV study in 50 acne patients who have G6PD deficiency and follow them for 6 months, after which QLT expects to submit an application to the FDA for re-evaluation of the Aczone label.

Other Drug News

Massachusetts Medicaid Adds Prior Authorization FOr TCIs
The Massachusetts Medicaid program announced that as of August 1, it will require prior authorization for pimecrolimus (Elidel) and tacrolimus (Protopic). The state’s change in prior authorization for these topical agents used to treat eczema comes as a result of the FDA request that labeling for Elidel and Protopic carry a “black box” warning about potential cancer risk.

Genentech Issues Warning for Raptiva
Last month, Genentech informed healthcare providers of new safety information regarding efalizumab (Raptiva), which is indicated for the treatment of adult patients with chronic moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In a letter to healthcare providers that was sent with new package inserts for Raptiva, Genentech said the safety information includes a warning regarding events of immune-mediated hemolytic anemia and updated warnings regarding post-marketing reports of serious infections and thrombocytopenia. Two cases of hemolytic anemia were observed during clinical trials for Raptiva, and two cases were reported in the post-
marketing setting. In two severe cases, hemoglobin decreased to 6 g/dl and 7 g/dl.
According to the company, “A casual relationship between Raptiva and these events has not been established but cannot be excluded.”
Genentech asks that any serious adverse events suspected to be associated with use of Raptiva be reported to the company at (888) 835-2555 or to the FDA’s MedWatch reporting system by phone at (800) FDA-1088.

Foamix Reports Positive Results for PerFoam
Foamix announced the results of its Phase II/III study on PerFoam (1% permethrin) for the treatment of lice. For the study, 56 children, aged 3 to 16, with head lice were treated with PerFoam. The foam was applied to the hair for 10 minutes and then washed off. Treatment was repeated 10 days later. Data shows evidence of safety and a 96.4% efficacy rate in killing the lice on the first application.
Foamix says it anticipates launching PerFoam in the Israeli market in 2006 and in the global market in 2006/2007.

Update on Medicare Pay-for-Performance Bill
In late June, Senator Chuck Grassley (R-Iowa) and Senator Max Baucus (D-Montana) presented a bill based on pay-for-performance recommendations from the Medicare Payment Advisory Commission. The bill called for providers who report quality data and satisfy particular quality standards to receive full Medicare reimbursement plus bonuses. Providers who do not report data starting in 2007 would receive full Medicare reimbursement minus 2%. This penalty would be on top of whatever reductions are mandated by the physician payment formula, which is projected to be at least a 4% cut in each of the next 6 years, according to a report on amednews.com. If this bill became law, starting in 2008, federal officials would set aside 1% of Medicare reimbursements to fun the bonus pool. The bonus pool would increase each year until 2012 when it hits the 2% maximum.

New Bill Would Repeal Planned Cuts
Late last month, a bill introduced by Nancy Johnson (R-Conn), would cancel the proposed cuts over the next 6 years and calls for pay-for-performance guidelines. The bill would provide physicians with inflation-based increases each year, though physicians who fail to meet specified quality standards would receive smaller increases. The quality measurement criteria would be set by physicians, quality organizations and Medicare officials.
According to Reuters Health, the main hurdle this bill faces is that canceling the scheduled pay cuts will cost the federal government as much as $180 billion over the next 10 years.

Scientists Discover Gene Mutation in Melanoma
Scientists at the Department of Medical Oncology and Melanoma Program in Medical Oncology at the Dana-Farber Cancer Institute in Boston, have discovered a genetic mutation in melanoma skin cancer cells that increases the severity of melanoma. These findings were reported in the June issue of the journal Nature.
Extra copies of the gene MITF (microphthalmia-associated transcription factor) were found when scientists looked at cells from patients with early and advanced melanoma tumors. The scientists found that MITF amplification was more prevalent in metastatic disease and correlated with decreased overall patient survival. The MITF mutation was also linked to other genetic chances such as mutations in the BRAF gene and silencing of the tumor suppressing gene p16. Scientists reported that reduction of MITF activity sensitizes melanoma cells to chemotherapeutic agents. The genetic mutation could be a target for new melanoma treatment drugs.

In Brief...
Photomedex Inc., Announced…that UnitedHealthcare has adopted a medical policy covering medically necessary treatment of mild to moderate psoriasis using the PhtotoMedex XTRAC laser system.

New National Rosacea Society Survey Found…that most of the estimated 14 million rosacea sufferers in the United States experience a progression in the condition beyond one subtype. In the survey of 1,233 rosacea patients, 72% reported that their rosacea had evolved from one subtype to another and 77% said they had experienced more than one subtype at the same type.

Women’s Dermatologic Society Announced…that it received the American Academy of Dermatology’s Gold Triangle Award for the society’s “Play Safe in the Sun” program. The WDS also announced the national launch of its “Families Play Safe in the Sun” in Boston at the end of June to kick off a 15-city, 3-year sun safety educational outreach geared for students and families. The program was made possible by a $1 million grant from the 3M Foundation and will feature WDS dermatologist volunteers from its 1,200 members.

Sirius Laboratories Announced Results…of study on 4% nicotinamide (Nicomide-T Gel and Cream). The study, conducted over 8 weeks, showed the usefulness of this acne preparation as an adjunctive and stand-alone tool for mild to moderate inflammatory acne. Interim results with 212 patients showed that 81% of patients reported either significant or some visible improvement in their condition after 2 weeks of using nicotinamide gel or cream. Also, 87% of patients in the study felt that Nicomide-T gel or cream used in combination with their current acne medication(s) was more useful than previously used therapies alone, according to Sirius. The study showed that patients found the product easy to use. And, 84% reported that they were better able to tolerate other acne medication when they added the Nicomide-T to their treatment.

Stiefel Laboratories Announced…the launch of its new corporate Web site, www.stiefel.com. On the site, Stiefel depicts its mission and values, provides an overview of products and a physician locator tool. Stiefel also announced the appointment of Dr. Marco Taglietti to the newly created position of Senior Vice President, Head of Global Research and Development.

New American Cellulite Task Force Established…to focus on the widespread, but misunderstood occurrence of cellulite. Michel van Welden, a researcher in connective tissue disorders and task force Executive Director, heads up a multidisciplinary panel of physicians. The ACTF hopes to provide media, consumers, medical and aesthetic professionals with research, education and advocacy on cellulite. n

Clarification
In the June 2005 supplement to Skin & Aging, Winter Clinical Dermatology Confer-ence Hawaii, an error was noted in both the section that is revised below and in the accompanying table. The following revision of the appropriate section from the original article includes the corrected information identified in italics (see both text and the accompanying table).
Longevity Of Clearance Of Actinic Keratosis After Treatment With Topical Imiquimod
The accompanying table outlines results of long term clearance of actinic keratosis after treatment with topical imiquimod (Aldara) applied 3 times weekly for 12 weeks.1 At follow up after 2 years, 80% of patients remained clear of actinic keratoses in the treatment field as compared to 10% of patients treated with vehicle only. A larger analysis evaluating long-term response rates after use of topical imiquimod either two or three times per week has been completed with publication of results anticipated in the near future.

REFERENCES
1. Stockfleth E. Christophers E, Benninghoff B, et al. Low incidence of new actinic keratoses after topical 5 % imiquimod cream treatment: a long-term follow-up study. Arch Dermatol. 2004;140:1542.