Update on Drugs and Drug News – March 2008

The US FDA approved this biologic agent in January 2008 for the treatment of adults with moderate-to-severe chronic plaque psoriasis who are not suitable candidates for other systemic therapies.

The US FDA approved a labeling change for this antihistamine in January 2008 to advise consumers that this OTC formulation relieves allergy symptoms caused by both perennial and seasonal allergies.

The US FDA approved this non-nucleoside reverse transcriptase inhibitor (NNRTI) in January 2008 for the treatment of HIV infection in adults who have failed other antiretroviral therapies. NNRTIs block cellular replication. For use in combination with other antiretroviral agents.

In recent studies led by dermatologists David McDaniel and Zoe Draelos, the efficacy of a new antioxidant, coffeeberry (REVALÉSKIN™, Stiefel Laboratories), was assessed. Dr. McDaniel led a 6 week, double-blind study of 30 subjects aged 30-70 years with a variety of skin types. Dr. Draelos conducted a 12 week study with 50 women aged 30-50 years with mild-to-moderate photoaging. Improvement in skin texture was seen after 3 weeks. The statistically significant findings from both investigations showed improvement in overall skin appearance.

Efalizumab (Raptiva®, EMD Serono Canada Inc.) is the first biologic treatment for psoriasis to receive public reimbursement through the provincial formularies in the Canadian provinces of Nova Scotia and New Brunswick. The benefit of Exceptional Status provides drug coverage to patients with severe, debilitating psoriasis.

At the 66th annual meeting of the American Academy of Dermatology*, clinical data was presented from a multicenter, randomized, double-blind Phase II study on oral apremilast (CC-10004, Celgene Corporation) for the treatment of moderate-to-severe plaque-type psoriasis. Apremilast inhibits the production of various proinflammatory mediators such as interleukin-2 (IL-2), IL-17, and IL-23, interferon-., TNF-a, leukotrienes, and nitric oxide synthase, which in combination, are responsible for immune-mediated inflammatory diseases. Interim findings showed that 24.4% of subjects treated with 20mg of oral apremilast every 12 hours experienced =75% improvement in their symptoms, as measured by the Psoriasis Area and Severity Index (PASI) after 84 days vs. 10.3% in the placebo group (p=0.023). Fifty-seven percent of subjects in the active treatment group achieved a PASI 50 response rate compared with 23% of subjects receiving placebo (p < 0.001). PASI 90 was attained by 14% in the apremilast group vs. 5.7% of those who received placebo (p=0.113). Substantial improvement in patient quality of life, as measured by the Dermatology Life Quality Index (DLQI), was reported by patients in the apremilast arm. Based on the favorable mid-stage data, Celgene is expanding the dosage of apremilast to 30mg and extending the treatment period up to 6 months from 84 days. The most common side-effects reported were headache, nasal inflammation, nausea, and diarrhea.
*A Phase 2 Study Demonstrating the Efficacy and Safety of the Oral Therapy CC-10004 in Subjects With Moderate to Severe Psoriasis. Abstract P2614. Presented at: the 66th Annual Meeting of the American Academy of Dermatology (February 1-5, 2008) in San Antonio, TX, USA.