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Pliaglis gains FDA approval as topical anesthetic peel
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The FDA has approved a supplemental New Drug Application for a 7% lidocaine/7% tetracaine cream as a topical local anesthetic to minimize pain during dermatologic procedures, according to its Canadian manufacturer.
Pliaglis 7%/7% Cream (Nuvo Research) forms a pliable peel on the skin when exposed to air, the company and Galderma Laboratories, which markets the product, said today in a joint press release. It is indicated for use on intact, adult skin to provide local analgesia for superficial aesthetic procedures, including dermal filler injection, pulse dye laser therapy, facial laser resurfacing and laser-assisted tattoo removal.
In clinical studies, the most common reactions to Pliaglis were erythema (47%), skin discoloration (16%) and edema (14%); all were generally mild and resolved soon after treatment, the news release said. Adverse events included headache, vomiting, dizziness and fever, all occurring less than 1% of the time, according to the release.
“Pliaglis offers a pre-treatment solution and contributes to improving the patient experience of an aesthetic treatment,” Francois Fournier, president of US and Canadian operations of Galderma Laboratories, said in the release.
“Pliaglis is an important part of Nuvo’s expanded topical pain product portfolio,” said Bradley S. Galer, MD, president of Nuvo’s Pain Group.