On March 24, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration showed that the application for the listing of the 5.1 new drug lidocaine prilocaine aerosol jointly submitted by Plethora Solutions and Fosun Pharma was officially accepted. The drug's trade name is Fortacin, which has been on the market in the EU for more than ten years and has been converted to OTC. If lidocaine prilocaine aerosol is approved, it will fill the gap in the field of premature ejaculation treatment in China, which has long relied on the oral drug dapoxetine, and provide patients with a new option of "one spray and immediate effect".
Premature ejaculation is one of the most common sexual dysfunctions in men, with an incidence rate of 2.3% among urban men in China. Currently, the only drug approved for the treatment of PE in China is the oral selective serotonin reuptake inhibitor (SSRI) dapoxetine, but it needs to be taken 1-2 hours in advance and has systemic side effects such as dizziness and nausea. Lidocaine prilocaine aerosol is used as a topical spray. It directly reduces the sensitivity of the glans penis through the dual local anesthetic effects of lidocaine and prilocaine. It takes effect quickly within 5 minutes and is effective after the first spray.

According to domestic public information, the Phase III clinical data of lidocaine prilocaine aerosol is impressive. The patient's intravaginal ejaculation latency time (IELT) was extended from a baseline of 0.56 minutes to 2.6 minutes, a 6-fold increase compared to the placebo group (p<0.0001), and sexual satisfaction, ejaculation control and distress scores were significantly improved. The study included 295 patients, and the results showed that it was well tolerated and had no systemic adverse reactions, which is consistent with European and American data.

Since Fortacin, the original lidocaine and prilocaine aerosol drug, was launched in the EU in 2013, it has covered more than one million patients. The market was further expanded after it became OTC in 2020, and Fosun Pharma obtained exclusive rights in China in 2018. According to Yaozhi data, the domestic premature ejaculation treatment market has exceeded 1.3 billion yuan in size. With the addition of lidocaine and prilocaine aerosols, a new competitive landscape will be formed in which oral drugs and topical preparations will run parallel.
Currently, there are 10 companies in China, including Shanghai Zezheng Pharmaceutical, that have developed this product. As patients' demand for private treatment and immediate medication increases, lidocaine and prilocaine aerosol may become the next "hot item" in the field of andrology.
If lidocaine prilocaine aerosol is approved for marketing, it will not only ease the clinical monopoly of dapoxetine, but also expand its accessibility through the OTC route, benefiting tens of millions of potential patients. It is worth continued attention whether Fosun Pharma can leverage lidocaine and prilocaine aerosol to gain another foothold in the men's medicine market.

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