Update on Drugs and Drug News: January 2011

Calcipotriene/Calcipotriol0.005% foam
Sorilux™

Stiefel, a GSK Company

The US FDA approved this calcipotriene 0.005% foam formulation in October 2010 for the topical treatment of mild to moderate plaque psoriasis in patients =18 years of age. Calcipotriene, a synthetic vitamin D3 analog, has been formulated using the VersaFoam® vehicle, a proprietary delivery technology.

Ceftaroline fosamil
Teflaro™
Forest Laboratories, Inc.

The US FDA approved this novel broad-spectrum injectable cephalosporin antibiotic in November 2010 for the treatment of community acquired bacterial pneumonia and complicated skin and skin structure infections. Ceftaroline has activity against both Gram- positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and Streptococcus pneumoniae, and common Gram-negative pathogens.

In October 2010, data from a Phase II efficacy and safety study of oral tasocitinib (CP-690,550, Pfizer), a Janus kinase (JAK) inhibitor, for the treatment of moderate to severe plaque psoriasis was presented in two posters (P558 and P616) at the 19th Congress of the European Academy of Dermatology and Venereology in Gothenburg, Sweden. JAK pathways are believed to play a key role in the inflammatory cascade associated with psoriasis. The double-blind, placebo-controlled, dose-ranging study involved 197 adult patients. Tasocitinib met its primary endpoint by demonstrating statistical significance with a greater proportion of patients achieving at least a 75% reduction from baseline in Psoriasis Area and Severity Index (PASI) at week 12. PASI 75 responses for tasocitinib 2mg, 5mg and 15mg twice daily groups were 25.0%, 40.8% and 66.7%, respectively, vs. placebo, 2.0%. Treatment with tasocitinib 5mg and 15mg twice daily significantly improved patient reported health-related quality of life outcomes as early as week 4. The most frequently reported treatment-related adverse events were upper respiratory tract infection and headache. Three patients experienced a total of five serious adverse events. Dose dependent decreases in mean neutrophil counts and hemoglobin values and increases in mean LDL, HDL and total cholesterol levels were observed.

In September 2010, Health Canada approved a new indication for the use of tacrolimus (Protopic®) ointment as maintenance therapy in moderate to severe atopic dermatitis. The updated product monograph includes:

Indications and Clinical Use for Maintenance

• Tacrolimus is also indicated for maintenance therapy to prevent flares and prolong flare-free intervals in patients with moderate to severe atopic dermatitis experiencing a high frequency of flares (i.e., occurring =5 times per year) who have had an initial response (i.e., lesions cleared, almost cleared or mildly affected) with up to 6 weeks of treatment with twice daily Protopic®.

Administration for Maintenance

• Patients who have a high frequency of flares and are responding to up to 6 weeks of acute treatment with tacrolimus ointment twice daily are suitable for maintenance treatment. Protopic 0.03% or 0.1% should be applied once daily twice a week. There should be 2 to 3 days between applications (e.g., Monday and Thursday). The product is applied as a thin layer to skin areas normally affected by atopic dermatitis (e.g., face, neck, and eyelids).
• Upon recurrence of signs/symptoms of flares, twice daily treatment can be reinitiated.