Name/CompanyApproval Dates and Comments

Capsaicin 8% Patch

NeurogesX, Inc.

The US FDA approved this dermal delivery system containing prescription strength capsaicin in November 2009 for the management of neuropathic pain due to postherpetic neuralgia (PHN). This medicated skin patch contains a synthetic form of capsaicin, which can provide up to 12 weeks of pain reduction following a single 1-hour application.

Alitretinoin Capsule
Basilea Pharmaceutica

Health Canada approved this new once-daily oral retinoid in November 2009 for the treatment of adults with severe chronic hand eczema refractory to potent topical corticosteroids.

Drug News

A recent study by Kenter et al.* explored the efficacy of a human papillomavirus (HPV) vaccine in 20 women with precancerious vulvar lesions. Vulvar intraepithelial neoplasia is chronic and caused by high-risk types of HPV, especially type 16 (HPV-16). The objective of the trial was to assess the immunogenicity and efficacy of a synthetic long-peptide vaccine in women with HPV-16-positive, high-grade vulvar intraepithelial neoplasia. Patients were vaccinated 3-4 times. At 3 months after the last vaccination, 60% of patients showed clinical responses and reported relief of symptoms. Five women had complete regression of the lesions, and HPV-16 was not detectable in 4 subjects. At 12 months of follow-up, 79% of patients showed clinical responses, with a complete response exhibited by 47%. The complete response rate was maintained at 24 months of follow-up. All patients had vaccine-induced T-cell responses; retrospective analyses indicate that subjects demonstrating a complete response at 3 months experienced a significantly stronger induction of HPV-16-specific immunity, when compared with patients without a complete response. This study shows that it may be possible to vaccinate against and treat HPV-induced premalignance. If validated by larger trials, this novel therapeutic approach has the potential to reduce the need for more intensive treatments, such as cryotherpay and laser surgery.

* Kenter GG, et al. N Engl J Med 361(19):1838-47 (2009 Nov 5).

At variance are reports linking psoriasis with lymphohematopoietic malignancies (e.g., leukemia and lymphoma) and solid cancers. In an observational study using the UK General Practice Research Database, cancer incidence was compared between patients with and without psoriasis; duration of disease and treatments used were also examined. Among 67,761 patients, 1703 had incident cancer, with 54% having had a history of psoriasis. Incidence rate ratios for lymphohematopoietic and pancreatic cancers were 1.81 (95% CI 1.35-2.42) and 2.20 (95% CI 1.18- 4.09), respectively. In a nested case-control analysis with this cohort, adjusted odds ratios (ORs) for cancer overall were 1.50 (95% CI 1.30-1.74) for psoriasis of >or=4 years duration and 1.53 (95% CI 0.97-2.43) for patients receiving systemic therapy. Findings revealed that highest risk for lymphohematopoietic malignancies was associated with systemic treatment. The OR for patients without systemic treatment was 1.59 (95% CI 1.01-2.50) for psoriasis of < 2 years and 2.12 (95% CI 1.45-3.10) for that of >or=2 years duration. Increased risk of bladder/kidney and colorectal cancers correlated with longer-duration psoriasis. Although further study is necessary, longer-term and more severe psoriasis appears to confer an increased, but not significant, risk for certain cancers.

Brauchli YB, et al. J Invest Dermatol 129(11):2604-12 (2009 Nov).