Update on Drugs and Drug News

Update on Drugs and Drug News – May 2006

By

STL Volume 11 Number 4

-

May 1, 2006

UPDATE ON DRUGS
Class	Name/Company	Approval Dates and Comments
Corticosteroids	Fluocinonide VANOS™ 0.1% Cream Medicis	The US FDA approved an additional indication in March 2006 for this class I corticosteroid as a primary therapy for all inflammatory and pruritic skin conditions, including eczema and poison ivy, in patients 12 years of age or older who are responsive to corticosteroids. It was originally indicated for the treatment of plaquetype psoriasis.
Antiarthritic Agent	Infliximab Remicade® Centocor	The Australian Health Regulators approved an additional indication for this biologic therapy in March 2006 for the treatment of psoriatic arthritis.The US FDA granted priority review of this biologic therapy in April 2006 for the treatment of moderate-to-severe active pediatric Chrohn’s disease in patients who have had an inadequate response to conventional therapies.
Antibacterial Agent	Tigecycline TYGACIL® Wyeth Pharmaceuticals	The EMEA’s Committee for Medicinal Products for Human Use recommended approval of this new class of antibiotics in March 2006 for the treatment of complicated skin and soft-tissue infections and complicated intra-abdominal infections.

Drug News
Drug Warning	Finalizing a safety review of tacrolimus (Protopic®, Astellas) and pimecrolimus (Elidel®, Novartis) that began in April 2005, the EMEA’s Committee for Medicinal Products for Human Use concluded that the benefits associated with the use of these dermatological medicinal products outweigh the risks, but that they should be used with greater caution in order to reduce potential risks of skin cancer and lymphoma as far as possible. The Committee recommended changes to the current product information, aimed at raising awareness of the potential long-term risks. They requested that the companies gather more data on the longterm safety profile.
Industry News	Metronidazole (MetroGel® 0.75%, Galderma) has been a mainstay for the treatment of rosacea. In July 2005, MetroGel® 1% was approved by the US FDA. It incorporates a higher concentration of metronidazole, allowing for a once-daily dosing as opposed to the twice-daily dosing required by most other rosacea treatments. Galderma reports that a new 60gm size is now available, and that they are no longer marketing the 0.75% formulation.
Industry News	Penciclovir 1% cream (Denavir®), which is approved in Canada for the treatment of outbreaks of herpes labialis in adults, is now being distributed by Barrier Therapeutics. It is the only topical antiviral prescription product approved by Health Canada for treating this condition..
Systemic Lupus Erythematosus	A study recently published in the New England Journal of Medicine* reported that women with either inactive or stable systemic lupus erythematosus were able to take oral contraceptives without increased risk of flares. Subjects who took triphasic 35ìg ethinylestradiol/0.5-1mg norethindrone for twelve 28-day cycles had no statistically significant difference in the occurrence of flares than those taking placebo. Severe flares occurred in about 7% of the women, regardless of whether they received oral contraceptives or placebo. *Petri M, et al. N Engl J Med 353:2550-8 (2005).