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Update on Drugs and Drug News: July-August 2009


Name/Company Approval Dates and Comments

Benzyl Alcohol Lotion 5%
Sciele Pharma

The US FDA approved this prescription medication in April 2009 for the treatment of head lice infestation for use in patients 6 months of age and older.

Red Light Technology Device + Methyl Aminolevulinate Cream
Aktilite® CL 128 + Metvix®
Photocure/ Galderma

Health Canada approved this LED-based narrow band red light technology device in combination with methyl aminolevulinate in April 2009 for the treatment of actinic keratosis and superficial basal cell carcinoma.


Drug News

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. announced in April 2009 that a Phase III trial evaluating sorafenib tablets (Nexavar®) in patients with unresectable Stage III or Stage IV melanoma was stopped early following a planned interim analysis by the independent Data Monitoring Committee (DMC). The trial was sponsored by the National Cancer Institute (NCI) and led by the Eastern Cooperative Oncology Group (ECOG) under a Clinical Trials Agreement between NCI and Bayer and Onyx. The DMC concluded that the study would not meet the primary endpoint of improved overall survival among patients receiving sorafenib in combination with the chemotherapeutic agents carboplatin and paclitaxel vs. patients receiving placebo plus the chemotherapeutic agents. The treatment effect was comparable in each arm. There were no unexpected serious side-effects, though the final analysis of the data will occur per protocol and statistical analysis plan. Bayer and Onyx will further review the findings of this analysis to determine what, if any, impact these data might have on other ongoing sorafenib melanoma trials. Data from this study are expected to be presented at an upcoming scientific meeting.

In a study presented at the 2009 Annual Meeting of the American Academy of Allergy, Asthma & Immunology*, researchers at Mount Sinai Hospital in New York studied 14 patients with persistent atopic dermatitis who received traditional Chinese medicine at Ming Qi Natural Health Center in Manhattan between August 2006 and May 2008. The treatments consisted of Erka Shizheng Herbal Tea, a bath additive, creams, and acupuncture. The study authors utilized 2 measures: the SCORAD index to gauge atopic dermatitis severity and the Dermatology Life Quality Index (DLQI) to calculate impairment to life quality. Baseline median scores for SCORAD and DLQI were 89 and 17, respectively. After a median 8 months of treatment, the median scores fell to 11 for SCORAD and 1 for DLQI. In all but 1 patient, SCORAD measures decreased between 60% to 90% after 3.3 months of treatment. More than 50% improvement in DLQI scores was documented in all but 1 patient after 2.4 months. Patients also reported a reduction in the use of steroids, antibiotics, and antihistamines within 3 months of being treated with traditional Chinese medicine. There were no abnormalities of liver and kidney function observed. While the researchers concluded that the use of traditional Chinese medicine is safe and effective for patients with persistent atopic dermatitis, especially those with a severe case and significant life quality impairment, it is still recommended to speak with a physician before taking any complementary or alternative medicines.

* Wisniewski J, Nowak-Wegrzyn A, Steenburgh-Thanik H, et al. Efficacy and safety of traditional Chinese medicine for treatment of atopic dermatitis (AD). J Allergy Clin Immunol 123(Suppl 2):Abstract #131 (2009 Feb).


In this issue:

  1. Methyl Aminolevulinate-PDT for Actinic Keratoses and Superficial Nonmelanoma Skin Cancers
  2. Adapalene 0.1% and Benzoyl Peroxide 2.5%: A Novel Combination for Treatment of Acne Vulgaris
  3. Update on Drugs and Drug News - July-August 2009