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Information about Fortacin

What is it and what is it used for?

Fortacin is a medicine containing the active substances lidocaine and prilocaine. It is used to treat men with primary (lifelong) premature ejaculation (when ejaculation regularly occurs before, or too early during, penetration).

How Fortacin is used
Fortacin can only be obtained with a prescription and is available as a spray-on solution that supplies 7.5 mg of lidocaine and 2.5 mg of prilocaine per spray. The recommended dose is three sprays onto the head (glans) of the penis before intercourse. Doses should not be repeated more frequently than every 4 hours, and no more than three doses should be used in 24 hours. For further information, see the package leaflet.

How Fortacin works
The active substances in the medicine, lidocaine and prilocaine, are local anaesthetics that temporarily numb the contact area by reversibly blocking the transmission of signals in the nerves. This reduces sensitivity to stimulation, helping to increase the time taken to ejaculate.

What are the benefits?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) considered that the active ingredients are a well-known local anaesthetic combination, and the use of a local spray minimises the amount of active substance absorbed and hence the risk of side effects affecting the body as a whole. There were positive psychological benefits to patients and their partners, and side effects were local and generally manageable. The CHMP therefore decided that Fortacin’s benefits are greater than its risks and recommended that it be approved for use in the EU.

What are main side effects?

The most common side effects with Fortacin (which may affect up to 1 in 10 people) are hypoaesthesia (reduced sensation) and a burning sensation in the genital area in both men and their female sexual partners, and erectile dysfunction (inability to maintain a normal erection) in men. For the full list of all side effects reported with Fortacin, see the package leaflet. Fortacin must not be used in patients who are hypersensitive (allergic) to any of the ingredients of the medicine or to other local anaesthetics with a structure related to the active ingredients (amide-type local anaesthetics). Fortacin must also not be used in patients whose partners are hypersensitive to these substances.

What studies have been done?

The effectiveness of Fortacin has been shown in two main studies involving a total of 256 and 300 heterosexual adult men with premature ejaculation, respectively; both studies compared the medicine with a placebo (dummy) spray over 12 weeks. The main measures of effectiveness were the time taken to ejaculate after penetration and the amount of control over ejaculation, sexual satisfaction and distress reported by the patients. In the first study, the average time to ejaculation in patients treated with Fortacin was 2.6 minutes, compared with 0.8 minutes in those using placebo; in the second study, average ejaculation time in patients using the medicine was 3.8 minutes compared with 1.1 minutes in the placebo group. In both studies, patients given the medicine reported substantially greater improvements in reported control, sexual satisfaction and distress than patients given the placebo. Some patients were monitored for up to 9 months in an extension of the initial studies and continued to show similar benefit.

Sources

Fortacin was first approved for use in the EU in 2013. It is manufactured by Plethora Solutions Limited.

European Medicines Agency website page for Fortacin (accessed 22/07/18)
NICE website
SMC website

Links available in External Resources

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


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For the full list of side effects and restrictions, see the package leaflet (link to package leaflet available in External Resources).