|Class||Name/Company||Approval Dates and Comments|
The US FDA approved this topical immunomodulator in December 2001, for the short-term and intermittant long-term treatment of mild to moderate atopic dermatitis in patients <2 years of age who do not respond well to, or may have side effects with conventional treatments.
The US FDA approved this antifungal agent in December 2001, for the nonprescription treatment of superficial dermatophytoses.
The US FDA approved new labeling in November 2001, for treatment of cutaneous and inhalation anthrax after exposure.
The US FDA approved this topical scalp oil in November 2001, for treatment of psoriasis in patients 2-5 years of age.
The EMEA granted orphan drug status in December 2001, for the treatment of multiple myeloma and erythema nodosum leprosum.
In a double-blind, placebo-controlled trial, RB Nadelman, et al*, recently found that a single dose of doxycycline when administered within 72 hours after a tick bite, was more effective than placebo in preventing the development of Lyme Disease. *N Engl J Med 345(2):79 (2001 July)
Debacterol® (Northern Research Laboratories), a topical canker sore treatment that has, until recently, been available only through dentists and other healthcare professionals will soon be available to the general public. Debacterol® is the only canker sore treatment available that chemically cauterizes the oral lesion in a single treatment.
Micrologix Biotech recently completed a Phase I placebo-controlled study of their new anti-acne treatment, MBI 594AN. This compound is a synthetic, cationic peptide that acts by damaging the bacterial membrane, which results in the rapid death of the treated bacteria. Results from this study indicate that no resistance developed to MBI 594AN among the strains of P. acnes present in the 36 patients who were treated for 6 weeks. Phase II results are anticipated soon.
A pilot study at the National Institute of Allergy and Infections Diseases suggests that certain people with HIV disease may be able to move from a continuous regimen of anti-HIV therapy to a strategy in which they discontinue and then resume their anti-HIV treatment in a pre-planned, cyclic manner. The approach is known as “structured intermittent therapy”. After the study, patients found that there was no deleterious effects on the course of their disease, and as well, noted a significant reduction in drug related side-effects. The investigators also found significant reductions in serum cholesterol and triglyceride levels. Further randomized, controlled clinical trials are currently underway.