New version of Pliaglis anaesthetic cream

January 6, 2020 0 By FM

Crescita Therapeutics announced that the US FDA approved the enhanced formulation of Pliaglis following its statutory six-month review process and in line with the target action date under the Prescription Drug User Fee Act (PDUFA). 

Pliaglis, a lidocaine and tetracaine (7%/7%) formulation, is a prescription topical local anaesthetic cream approved in over 25 countries that provides safe and effective local dermal anaesthesia on intact skin prior to superficial dermatological procedures, such as dermal filler injections, pulsed dye laser therapy, facial laser resurfacing and laser-assisted tattoo removal. 

This product utilizes the proprietary phase-changing topical cream Peel technology. The Peel technology consists of a drug containing cream which, once applied to a patient’s skin, dries to form a pliable layer that releases drug into the skin. Following the application period, 

The enhanced formulation of Pliaglis also contains 7% lidocaine and 7% tetracaine but possesses improved application and removal properties compared to Pliaglis, with extended patent protection to 2031 in multiple jurisdictions. 

Like Pliaglis, the formulation dries to form a pliable layer which can be easily peeled from the skin once the active ingredients have been delivered to the site on the body, providing a long-lasting anesthetic effect.