First topical treatment for premature ejaculation now available on prescription

Fortacin is the first topical treatment approved for the treatment of primary premature ejaculation.

Premature ejaculation is the most common form of sexual dysfunction in men. | Stock.com/Koldunova_Anna
Premature ejaculation is the most common form of sexual dysfunction in men. | Stock.com/Koldunova_Anna

Fortacin contains a mixture of the local anaesthetics lidocaine (150mg/ml) and prilocaine (50mg/ml) in a metered-dose aerosol spray. By blocking the transmission of nerve impulses in the glans penis, it reduces sensitivity and delays the intra-vaginal ejaculatory latency time (IELT) without adversely affecting the sensation of ejaculation.

The recommended dose is 3 actuations applied to the entire glans penis. After 5 minutes any excess spray should be wiped off prior to intercourse. A maximum of 3 doses can be used within 24 hours with at least 4 hours between doses.

Increased ejaculation latency

The clinical efficacy of the lidocaine/prilocaine spray has been evaluated in two phase III, multicentre, randomised, double-blind, placebo-controlled studies involving heterosexual adult men with premature ejaculation (n=300 and n=256, respectively). Primary efficacy outcome variables were the change from baseline to study end in mean IELT and in the Index of Premature Ejaculation (IPE) questionnaire domains of ejaculatory control, sexual satisfaction and distress.

In the first study, the mean IELT increased over the 3-month treatment period from a baseline of 0.6 minutes in both groups to 3.8 minutes in men treated with lidocaine/prilocaine spray compared with 1.1 minutes in those using placebo. This represented 6.3- and 1.7-fold increases, respectively, indicating a significant difference between treatments in favour of lidocaine/prilocaine.

In the second study, the mean IELT at baseline was 0.56 minutes in the lidocaine/prilocaine group and 0.53 minutes in the placebo group, and increased to 2.6 and 0.8 minutes, respectively, after 3 months. Again the treatment difference was significantly in favour of the combination.

In both studies, men treated with lidocaine/prilocaine spray reported significantly greater improvements in ejaculatory control, sexual satisfaction and distress than men given the placebo.

Safety profile

The spray was well tolerated in both studies. The most common side-effects in male patients were genital hypoaesthesia and erectile dysfunction. In female partners, vulvovaginal burning sensation and genital hypoaesthesia were most commonly reported.

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