Sunday, May 28, 2023
Recently, the "Pyridostigmine Bromide Sustained-release Tablets" developed by Shanghai Shanghai Pharmaceutical Zhongxi Pharmaceutical Co., Ltd., a subsidiary of Shanghai Pharmaceuticals, received the "Notice of Drug Clinical Trial Approval" issued by the State Drug Administration (notification number: 2023LP00758 ), will start clinical trials in the near future.
Pyridostigmine bromide is mainly used for the treatment of myasthenia gravis. It is a reversible anticholinesterase drug, which can inhibit the activity of cholinesterase, reduce the destruction of acetylcholine released from cholinergic nerve endings, and make the synaptic cleft Acetylcholine accumulates in the body, and muscarinic (M) and nicotinic (N) choline receptor excitatory effects occur. It has a direct excitatory effect on the nicotinic choline receptor (N2 receptor) on the motor end plate, and can promote the release of acetylcholine from the motor nerve endings, thereby increasing the muscle tone of the gastrointestinal tract, bronchial smooth muscle and skeletal muscle of the whole body. Compared with ordinary tablets, sustained-release tablets can reduce the number of times patients take it and help improve patient compliance.
In February 2023, the clinical trial application for this project was officially accepted by the State Food and Drug Administration. Recently, the project was approved by the State Food and Drug Administration to issue the "Notice of Drug Clinical Trial Approval", agreeing to carry out clinical trials according to the submitted protocol.
The IQVIA database shows that in 2022, the hospital purchase amount of the same API drug pyridostigmine tablets is RMB 56.49 million.
