Gufic Biosciences secures NMPA approval to market Prilocaine (API) in China

Gufic Biosciences has received approval from the National Medical Products Administration (NMPA) in China for its product, Prilocaine (API), an amide-type local anesthetic.

The approval will aid in the commercialization of Prilocaine in China, opening up new opportunities in the Chinese market for Gufic.

Prilocaine, which shares a similar clinical profile to lidocaine, is used for infiltration, peripheral nerve blocks, as well as spinal and epidural anesthesia. It is also used in conjunction with lidocaine for surface anesthesia.

Offering a significantly greater duration and safety margin, Prilocaine does not require the addition of epinephrine to prolong its duration of action, a feature that is beneficial when epinephrine is contraindicated.

The local anesthetic boasts the least systemic toxicity among all amide local anesthetics, making it particularly useful for intravenous regional anesthesia. Prilocaine also presents the highest clearance of all amino-amide local anesthetics, more than double the clearance of lidocaine.

Combined with its larger distribution volume, this characteristic results in a significantly lower prilocaine plasma concentration compared to lidocaine and mepivacaine after regional anesthesia, therefore, toxic blood concentrations are reached very rarely. Furthermore, Prilocaine is associated with fewer reported cases of transient neurological symptoms than lidocaine or mepivacaine.