Update on Drugs and Drug News - May 2010

Imiquimod 3.75% cream
Zyclara™
Graceway Pharmaceuticals

The US FDA approved this topical immune response modifier in March 2010 for the treatment of clinically typical, visible, or palpable actinic keratoses. This new formulation offers a convenient 6-week dosing cycle and is indicated for application over larger areas of skin (as compared with imiquimod 5%), including the full face and balding scalp in adults.

Adapalene 0.1% lotion
Differin®
Galderma Laboratories

The US FDA approved this novel lotion formulation of the retinoid adapalene in March 2010 for the treatment of acne vulgaris in patients 12 years of age and older. This new once-daily treatment has been designed to improve tolerable efficacy and spreads easily. It is available in an easy-to-use pump dispenser and is indicated for application on the face and other areas of the body that can be affected by acne.

Polidocanol injection
Asclera®
BioForm Medical Inc./ Chemische Fabrik Kreussler & Co.

The US FDA approved this sclerotherapy agent in March 2010 to improve the appearance of varicose veins. This injection treatment is used to close spider veins (<1 millimeter in diameter) and reticular veins (1-3 millimeters in diameter). The agent acts by damaging the cell lining of blood vessels, causing the vessels to close, and then are subsequently replaced by other types of tissue.

In April 2010, the US FDA issued warning letters to six US medical spas and a Brazilian company (Zipmed.net/Mesoone.com) for misbranding and allegedly making false or misleading website statements about certain drug products containing phosphatidylcholine and deoxycholate (PCDC). The therapeutic claims in question surround the elimination of fat when the agents are utilized in a procedure known as lipodissolve, which involves a series of micro-injections to the treatment site. The alleged mechanism of action is instigated when fat cells absorb the PCDC, causing inflammation and hardening. The hardened fat cells break- down within a few weeks, resulting in their permanent removal. The procedure is also known by other names, such as mesotherapy, lipozap, lipotherapy, or injection lipolysis. According to the US FDA, these products are considered to be new drugs with unproven safety and efficacy, and may not be marketed unless the required regulatory authorization has been sought. More information is available at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm.