Sichuan Meida’s Phentolamine Gains Priority Review for Pheochromocytoma Treatment

The Center for Drug Evaluation (CDE) website indicates that Sichuan Meida Kangjiale Pharmaceutical Co., Ltd’s phentolamine has obtained priority review status as a “clinically urgent, in-shortage drug.” This non-selective alpha-adrenoceptor antagonist is used to control paroxysmal hypertension in patients with pheochromocytoma before and during surgery.

Clinical Application and Mechanism
Phentolamine is used to manage hypertensive crises in pheochromocytoma patients and can also be employed for diagnostic examinations if other tests are unavailable or insufficient. Originated by Novartis, the drug was first approved in China in April 2002. It works by exciting the heart, dilating blood vessels, blocking 5-HT receptors, and promoting mast cell histamine release.

Supply and Procurement Context
Despite having nearly 30 generic versions approved for erectile dysfunction, phentolamine supply has been affected by China’s national volume-based procurement (VBP) normalization. A draft proposal for a common drug VBP alliance procurement involving phentolamine was released by the Chongqing healthcare security administration in May 2021.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry