Endurance announced that its commercial partner Wanbang Biopharmaceuticals has completed a Phase III study of Fortacin (lidocaine/prilocaine) in China for the treatment of premature ejaculation (PE).
The 295-patient, placebo-controlled Phase III trial met all four co-primary endpoints. Fortacin has marketing authorisation for PE in the EU, and Senstend is the brand name for Fortacin in China.
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Intravaginal ejaculation latency time (IELT), index of premature ejaculation (IPE) ejaculatory control, and IPE sexual satisfaction domains, as well as IPE distress, all showed positive results compared to baseline and placebo. Fortacin increased IELT, ejaculatory control and satisfaction while reducing distress.
Fortacin is a formulation of metered dose aerosol of lidocaine and prilocaine. It provides topical anaesthesia to the glans penis with lidocaine and prilocaine blocking the transmission of nerve impulses resulting in sensitivity reduction.
Premature ejaculation is a common occurrence in men. There are two types: primary, a long-term occurrence; and secondary, where PE was recently developed. PE is a complex condition with psychological, biological and social factors all at play. According to the American Urological Association, approximately one in five men between the ages of 18 and 59 report incidences of PE.
Endurance CEO Jamie Gibson said: “This represents an important milestone in the regulatory submission process in China. We now look forward to our commercial partner in China submitting the New Drug Application (NDA) to the National Medical Products Administration (NMPA) by the end of Q3 2023 with approval expected 12 months later.”
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By GlobalDataEndurance also reported strong uptake of Fortacin in the EU and especially in Germany. The manufacturer released 30,000 units in February 2023, with the next 30,000 scheduled for delivery in July 2023.
