Pipeline previews

Journal of Drugs in Dermatology, May, 2008 by Marissa Heller

Pipeline Previews brings you information on the newest drugs and medical products as they become available to the der-Teratologic community, including additional information from the manufacturers and physicians who wish to share their clinical experience with these new products. We will also inform you about the latest drugs receiving FDA approval.

Oral Alitretinoin for Severe Chronic Hand Eczema

A recent study showed that alitretinoin (9-cis-retinoic acid) led to the resolution of severe chronic hand eczema (CHE) in a large number of patients who had the disease that was re-fractory to first-line therapy. The full report of the randomized, double-blind, placebo-controlled, multicenter trial was published in the British Journal of Dermatobp (2008;158:808-817). The study enrolled a total of 1032 patients with severe CHE in 111 outpatient dermatology clinics in Europe and Canada. Patients were randomized in a ratio of 1:2:2 to the placebo, 10 rag, or 30 mg of oral alitretinoin taken once daily for up to 24 weeks. All patients were followed for 4 additional weeks, and patients who responded to therapy were followed for 24 additional weeks after the completion of therapy.

A response to therapy was defined as clear or almost clear hands. In total, 48% of patients treated with alitretinoin responded to therapy, as compared to 17% of patients treated with the placebo. The treatment was well tolerated with adverse effects including headaches, mucocutaneous events, hyperlipidemia, and the decreased free thyroxine and thyroid-stimulating hormone. In patients who did relapse, the median time to relapse was 5.5 to 6.2 months in the absence of anti-eczema medication.

Docosahexanoic Acid Supplementation in Atopic Eczema

A recent study shows that dietary docosahexanoic acid (DHA) may have beneficial effects on atopic eczema. A total of 53 patients with atopic eczema were enrolled in this randomized, double-blind, controlled trial and were randomized to receive either 5.4 g of DHA daily for 8 weeks or an isoen-ergetic control of saturated fatty acids. Patients were evaluated by the severity scoring of atopic dermatitis (SCO-RAD) index at weeks 0, 4, 8, and 20.

Results showed that DHA led to a significant clinical improvement of atopic eczema in the study group as measured by a decreased SCORAD compared to the control group. The full report can be found in the British Journal of Dermatology (2008;158:786-792).

Discontinuation of Phase 3 Trial for Advanced Melanoma

Pfizer Inc recently announced that its phase 3 clinical trial (A3671009) of tremelimumab (CP0675.206) for patients with advanced melanoma will be discontinued. The discontinuation came after the review of interim data indicated that this therapy would not be superior to standard chemotherapy. The full data from this study will be thoroughly analyzed and details are expected to be announced at the American Society for Clinical Oncology Annual Meeting in June 2008.

Gabapentin GR for Postherpetic Neuralgia

Depomed Inc recently announced that it has begun dosing in its new phase 3 clinical trial to evaluate the safety and efficacy of Gabapentin GR,M in the treatment of( postherpetic neuralgia (PHN). This randomized, double-blind, placebo-controlled clinical trial plans to enroll 450 patients with PHN who will be randomized to either 1800 mg of Gabapentin GR or to a placebo once daily. This study follows a prior phase 3 trial of Gabapentin GR in the treatment of PHN, which did not achieve statistical significance in its endpoints.

Oral Curcumin for Psoriasis Vulgaris

A recent prospective clinical trial evaluated the safety and efficacy of oral curcumin in the treatment of moderate to severe psoriasis vulgaris. This phase 2, open-label trial studied the effects of 4.5 g per day of oral curcuminoid C3 complex in patients with plaque psoriasis. The authors concluded that the response rate was low and that larger, placebo-controlled studies are necessary prior to recommending oral curcumin as a treatment for patients with psoriasis. The full report can be found in the Journal of the American Academy of Dermatology (2008;58:625-631).

EDA Alert of Quinolones and Phototoxicity

The FDA recently approved safety labeling revisions for lev-ofloxacin (Levaquin[R] tablets, oral solution, and intravenous injection). The new warning alerts patients and practitioners to the risk of photosensitivity and phototoxicity that can be found in association with quinolone antibiotics. The FDA has received reports of phototoxic reactions that mimic extreme sunburn reactions, and include erythema, vesicle formation, blister formation, and edema in areas exposed to light. Treatment with the quinolones should be discontinued if these reactions occur. In addition, patients should be told to minimize and avoid sun exposure while taking these medications.

Marissa Heller MD

Department of Dermatology, Boston University School of Medicine