Fosun：PSD502 approved for marketing in China.
On June 15, the NMPA official website showed that the Category 5.1 drug Lidocaine and Prilocaine Aerosol Spray, jointly filed by Plethora Solutions and Fosun Pharma, has been approved for marketing in China for the treatment of primary premature ejaculation in adult males (Acceptance No.: JXHS2500041).
Lidocaine and Prilocaine Aerosol Spray (development code: PSD502) was developed by Plethora Solutions. It was first approved in the European Union in 2013 and was switched from prescription to over-the-counter (OTC) status in 2020 following approval by the European Commission.
The rights to PSD502 have changed hands multiple times. In May 2009, Plethora Solutions transferred the global rights to PSD502 to Shionogi. However, a few years later, Plethora Solutions reacquired the global rights. In terms of commercialization, Recordati obtained the rights for Europe, Russia, CIS countries, Turkey, and parts of North Africa in 2014. In December 2018, Jiangsu Wanbang Biopharmaceuticals Group Co., Ltd., a subsidiary of Fosun Pharma, obtained the commercial rights for this drug in China.
As the second drug approved for the treatment of premature ejaculation worldwide, PSD502 has over a decade of use experience in Europe, with its efficacy and safety having been validated in clinical trials and real-world applications. After 3 months of treatment with PSD502, the intravaginal ejaculatory latency time in patients with premature ejaculation increased from a baseline of 0.56 minutes to 2.6 minutes, with significant improvements in the scores for ejaculatory control, sexual satisfaction, and distress as measured by the Premature Ejaculation Profile.
In China, Plethora Solutions and Fosun Pharma have conducted a total of three clinical trials for this drug: two Phase I trials and one Phase III trial. The two Phase I trials were conducted in healthy Chinese males and females, respectively. The results showed that treatment-emergent adverse events (TEAEs) occurred in 38.9% of male subjects and 66.7% of female subjects receiving PSD502, while the TEAE incidence in the placebo group was 50% for both males and females. All TEAEs were mild-to-moderate and transient, with no serious adverse events or events leading to study discontinuation. After multiple administrations, lidocaine and prilocaine were rapidly cleared from the subjects, with a half-life (t₁/₂) of approximately 4 hours, and Cmax values were less than 1/27 of the systemic exposure levels associated with systemic toxicity (5000 ng/mL).
The Phase III trial was a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of PSD502 in Chinese subjects with premature ejaculation. The study enrolled 295 subjects and was completed in February 2023. Specific study data have not yet been disclosed.
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