FDA Approvals & News

FDA Approves New Atopic Dermatitis Treatment
The FDA has cleared Stiefel Laboratories’ MimyX Cream, a new non-steroidal, prescription treatment for burning and pruritus associated with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis.
According to Stiefel, MimyX Cream is designed to restore the stratum corne-um’s natural structure and components.
A company statement reported that, “. . . essential ingredients found within MimyX Cream mimic natural components of the stratum corneum, thus helping repair and restore skin barrier function.” MimyX contains no emulsifiers, perfumes or dyes, and it is safe for children of all ages.

Psoriatic Arthritis Treatment Approved
The FDA has approved adalimumab (Humira) for reducing signs and symptoms of active arthritis in patients who have psoriatic arthritis. This is the second indication for Humira, which was first approved to treat rheumatoid arthritis.
Approval was based on data from the largest biologic trial in psoriatic arthritis, the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Results from this trial, which studied 313 patients with moderately to severely active psoriatic arthritis, found that patients who received the drug experienced significantly greater improvement in joint and skin disease symptoms at 24 weeks, when compared to patients receiving placebo. Improvements were seen as early as 2 weeks in the trial. Specifically, patients achieved the following results:
• 60% of patients achieved ACR20 at week 12 and sustained results through week 24.
• ACR70 (which is a much more difficult-to- reach endpoint) was achieved by nearly 25% of treated patients, as compared to only 1% of patients taking placebo, at week 24.
The recommended dose of Humira for treating psoriatic arthritis is 40 mg every other week via subcutaneous injection.

First Super-High Potency Steroid Spray for Psoriasis
The FDA granted approval for clobetasol propionate (Clobex Spray 0.05%), which is indicated for the treatment of moderate-to-severe plaque psoriasis. This prescription drug is the first super-high potency steroid spray for treating this condition.
FDA approval was based on data from two multi-center, randomized, double-blind studies of 209 patients who had moderate-to-severe psoriasis.
In the first trial: 82% of patients were clear or almost clear of psoriasis after 4 weeks of treatment — 47% of these patients were either clear or almost clear within the first 2 weeks.
In the second trial: 78% of patients were clear or almost clear of psoriasis within 4 weeks of treatment.
Clobex Spray is applied directly to lesions with the total dosage not to exceed 50 g, or 59 ml, which is equivalent to the 2-fluid ounce bottle in which the product is contained. In addition, patients should use Clobex Spray only for the minimum time period necessary to achieve results. This drug is not intended for patients under the age of 18 years.

New Laser Treatment for Fine Lines and Wrinkles
Lumenis has received FDA clearance for its new skin renewal system, Aluma, for the treatment of fine lines and wrinkles.
Aluma uses the company’s proprietary FACES (functional aspiration controlled electrothermal stimulation) technology. This technology combines bipolar radiofrequency energy with vacuum to enable superficial and deep dermal heating.
In a clinical study, 85% of patients showed visible improvement of treated wrinkles after a single session, and the results were shown to have lasted at the 6-month follow-up.

New Dates for iPledge Implementation
The FDA has revised the dates for the implementation of its new isotretinoin risk management program, iPledge. The dates will allow for more time for registration and activation. According to the revised plan:
• wholesalers and pharmacies must now be registered or activated on iPledge by Dec. 30, instead of Nov. 1 as previously stated.
• The patient registration start date is now Dec. 30 instead of the previous Nov. 1.
• Prescribers will now have until Mar. 1 to be activated in iPledge instead of the end of December, which was the original timeframe reported.

Nationwide Recall of Shampoo Caps
Salus Corp., has voluntarily initiated a nationwide recall of all lot numbers of shampoo caps with conditioner because some of the product is contaminated with the bacteria Serratia marcescens.
The shampoo caps, manufactured under the brand names CompleteBath, ReadyBath and No-Rinse, were distributed to healthcare facilities and institutions nationwide through Salus Corp., Medline Industries, and No Rinse Laboratories.
The shampoo caps may have been used in medical settings on patients who are immuno-compromised or have head wounds
S. marcescens has the potential to cause severe and life-threatening illnesses, especially in those with compromised immune systems. The bacterium has the potential to cause wound infections and then gain access to the bloodstream from infected wounds. To date, no adverse events have been reported.
If you have any of these products, return shampoo caps to the point of purchase or call Salus at (314) 429-1000.

New Formulation of Head-Lice Product
A multi-center, Phase III study in the United States to evaluate a novel formulation of malathion (Ovide Lotion 0.5%) is currently underway, according to the drug’s marketer, Taro Pharmaceuticals.
The company expects that the new formulation will maintain the efficacy of the original formulation of Ovide Lotion, a prescription product for the control of head lice in pediatric and adult patients.
Taro hopes that the new formulation will provide patients with shorter application time and greater ease of use, resulting in improved patient compliance.
Taro has filed a patent application in the U.S. Patent and Trademark Office with claims that cover this new, proprietary formulation.

The Value of Technology
Arecent Wall Street Journal Online/Harris Interactive Health-Care Poll showed that while only a minority of U.S. adults have experience with new medical technologies, such as electronic medical records and digital imaging equipment, in their doctor’s office, many are in favor of having their doctors adopt new technologies in their practices.
Here are some highlights from the online survey of 2,084 U.S. adults conducted by Harris Interactive between Sept. 30 and Oct. 4.
• 16% reported that their doctor has used an electronic medical
record to capture their medical information.
• 14% said their doctor uses a personal digital device to record
their information.
• 8% reported that their doctor has used e-mail to communicate.
• 8% reported that their doctor has used digital equipment that
allows them to send pictures or other images via e-mail.
• 5% have had experience with a home monitoring device that allowed them to send medical information, such as blood pressure readings or blood tests, to their doctor’s office via the telephone or e-mail.
While only a small number report experience with these technologies, at least 75% reported that they strongly or somewhat favor having their doctor(s) use these types of new technologies when caring for them or their family members.

Antibiotics and Acne Patients
Acne patients who have undergone more than 6 weeks of treatment with antibiotics were more than twice as likely to develop an upper respiratory tract infection (URTI) within 1 year than those acne patients not treated with antibiotics, according to an article in the September issue of Archives of Dermatology. Lead author David J. Margolis, M.D., Ph.D., of the University of Pennsylvania School of Medicine in Philadelphia, and colleagues identified individuals aged 15 to 35 years diagnosed with acne between 1987 and 2002 in a medical database in the United Kingdom. Using statistical models and controlling for possible confounding variables, the researchers compared incidence of URTIs in acne patients treated with antibiotics with those not. Of 118,496 individuals with acne, 71% received either topical or oral antibiotics for more than 6 weeks and 28.3% did not. Within the first year, 15.4% of all the patients developed at least one URTI. The odds of developing a URTI was 2.15 times more likely in the antibiotic-treated group than in the non-antibiotic group.

Correction
In the October column “Allergen Focus,” we regret that an error was listed in the table titled, “Products Containing Carbamates” on page 28. In the chart, under the heading “Medical Equipment,” thiuram was listed as containing carbamate. However, thiuram does not contain carbamate; it actually cross-reacts with carbamate. The chart should have correctly listed “disulfiram”.

In brief...
The Dermatology Foundation Announced…that Pui-Yan Kwok, M.D., Ph.D., Professor of Dermatology, Department of Dermatology at the University of California, San Francisco, will Chair the 2005-2006 Medical and Scientific Committee of the Dermatology Foundation. The Committee performs all peer-review functions relating to the Foundation’s Research Awards Program. Committee members are elected to 3-year terms and are chosen for their scientific expertise and knowledge. All members serve pro bono and do not participate in evaluations of applications from institutions with which they are associated or in which they have a conflict of interest.

The Dermatology Nurses’ Association Has Joined…forces with the Women’s Dermatologic Society (WDS) in a national education campaign to reduce skin cancer in the United States. The DNA is participating in events across the country as part of the WDS “Families Play Safe in the Sun” campaign. The program, which is supported by a $1 million grant from 3M Foundation, includes free screenings, education materials, complimentary products, youth-oriented contests and community programs. For more information, visit www.playsafeinthesun.org.

Humana and Representatives…of hundreds of thousands of physicians’ state and local medical societies announced that they have agreed to settle the national class action lawsuit pending in the federal court for the southern District of Florida before U.S. District Judge Federico Moreno. Approval of this settlement will provide a mechanism by which physicians can obtain compensation in connection with the claims in the lawsuits. Humana will establish a settlement fund from which physicians can seek compensation.