Today, China's National Food and Drug Administration (NMPA) announced that the pregabalin sustained-release tablets declared by Hengrui Medicine have been approved for listing in China
Public information shows that pregabalin is an analgesic, and Hengrui Medicine has applied for pregabalin sustained-release tablets, which belong to the 2.
2 new drugs
Screenshot source: NMPA official website
Pregabalin is an analogue of the neurotransmitter γ-aminobutyric acid (GABA).
The original drug was developed by Pfizer
It can bind to and inhibit the α2-σ subunit protein of voltage-dependent calcium channels, reduce the depolarization of nerve endings and calcium ion influx, thereby inhibiting the release of excitatory neurotransmitters such as L-glutamate
The release of these excitatory neurotransmitters is associated with convulsions, pain and anxiety
The original drug pregabalin has been approved for multiple indications worldwide, including diabetic peripheral neuropathy, post-herpetic neuralgia, fibromyalgia syndrome, neuralgia caused by spinal cord injury, and as an adjuvant therapy for adult patients Part of epileptic seizures and many other diseases
In China, Pfizer's Pregabalin capsules have been approved for marketing
In addition, a number of generic pregabalin capsules and pregabalin oral solutions have been approved
The dosage form declared by Hengrui Medicine is pregabalin sustained-release tablets
According to the information from the Chinese drug clinical trial registration and information disclosure platform, Hengrui Medicine has registered a number of phase 1 clinical studies of pregabalin sustained-release tablets, involving indications including post-herpetic neuralgia, fibromyalgia, and postoperative analgesia , fibromyalgia and so on
The approval of the drug will bring more treatment options to patients
 On September 28, 2021, the drug approval document pending information is released.
Retrieved Sep 28, 2021, from https://