FDA approves topical anesthetic cream

December 31, 2012

The Food and Drug Administration has approved a supplemental new drug application for a topical local anesthetic cream to be used in superficial cosmetic procedures.

Pliaglis cream (lidocaine 7 percent, tetracaine 7 percent; Nuvo Research/Galderma) is designed for use on intact skin in adult patients during aesthetic procedures such as dermal filler injections, pulsed dye laser treatments, facial laser resurfacing and laser-assisted tattoo removals, according to a company news release.

The cream uses a proprietary phase-changing technology to form a pliable peel on the skin when exposed to air, according to Nuvo. In clinical trials, local adverse events were generally mild and transient and resolved spontaneously soon after treatment. These reactions included erythema (47 percent), skin discoloration (16 percent) and edema (14 percent). The most common adverse events included headache, vomiting, dizziness and fever, all of which occurred with a frequency of less than 1 percent, according to the company.

Nuvo has licensed worldwide marketing rights for Pliaglis to Galderma. DT