This Fortacin Spray review will cover everything you should know about this product. Find out how effective it is as a premature ejaculation treatment.
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Fortacin is one of many delay sprays for men with premature ejaculation. Our Fortacin spray review will go over how effective it is and if it’s the best treatment option.
Ejaculating prematurely is a top concern for men in the bedroom. As many as one in three men struggle with premature ejaculation (PE).
Fortacin Delay Spray is a product designed to treat premature ejaculation through desensitizing the penis.
In reviews it's been stated that the effects of the product can last up to an hour.
Fortacin Spray is made with a combination of Prilocaine and Lidocaine.
One prescription treatment option in several countries is Fortacin spray. While it may soon be available in the U.S, it’s important to learn how it works, what ingredients it has, and more below.
Here are a few pros and cons to consider with Fortacin spray:
Fortacin is a topical delay spray made with a combination of lidocaine and prilocaine used to treat PE in men.
Fortacin was initially approved by the European Medicines Agency (EMA) for prescription use in 2013.
The treatment has been available with a doctor's prescription for nearly a decade, but only in the European Union and United Kingdom.
In addition to the name Fortacin, the medication has commonly been referred to as PSD502 and TEMPE in clinical studies.
While Fortacin spray has been available in other countries, it has not been available in the United States.
The latest word from the manufacturers in 2021 stated the product was slated to go through phase III clinical trials and then anticipated to be submitted to the U.S. Food and Drug Administration for approval.
This could mean Fortacin would be available in the U.S. by the end of 2023. Fortacin works by temporarily blocking nerve signal transmissions in the penis.
The lidocaine and prilocaine seep into the skin to disrupt these signals temporarily, which helps to delay ejaculation during sex.
According to usage guidelines supplied by the EMA, the recommended dose of Fortacin is three sprays applied specifically to the glans (head) of the penis.
The usage guidelines state that topical applications should be done as follows:
Fortacin has been shown to be effective for premature ejaculation.
Due to the fact that Fortacin has been approved for pharmaceutical use by the EMA, the spray has undergone extensive clinical testing.
In one of the initial studies published in 2009, 300 men with PE were randomized to receive either PSD502 or a placebo.
The baseline intravaginal ejaculatory latency times (IELT) for these men was just over half a minute (0.60 minutes).
During three months of treatment, men given Fortacin spray had increased IELT times to an average of 3.8 minutes. Secondary benefits were reported as well, such as sexual satisfaction scores.
A second study published in the Journal of Sexual Medicine in 2010, 256 men with PE were given either PSD502 or a placebo for three months.
IELT increased from about a half a minute to just over 2.5 minutes for the PSD502 group. The group given the placebo only had marginal improvements.
IELT times stayed below one minute. One of the latest mentions of Fortacin in clinical literature was in 2022 in the International Journal of Impotence Research.
The cross-sectional retrospective analysis looked at how men responded to treatment for PE with Fortacin at 6 and 12 months. At the 6-month mark, IELT times had significantly improved.
However, at 12 months, only about one-fourth of the men initially given Fortacin were still using the compound even though IELT times had improved.
There are no up-front specifics given by the EMA regarding how long Fortacin spray will deliver the desensitizing effects.
Nevertheless, the aforementioned guidelines provided by the EMA do state that Fortacin should only be used three times in a 24-hour period.
The user should also wait at least four hours after use to reapply. One Fortacin spray review stated that the product started working in about five minutes and the effects lasted for more than an hour.
Fortacin is made with the combination of lidocaine and prilocaine. Lidocaine is a common topical anesthetic agent that can be found in over-the-counter products, such as oral desensitizing gel for a toothache or lotions for sunburn pain.
Currently, products made with a combination of lidocaine and prilocaine, however, are only available with a prescription in the U.S.
Three sprays, or one dose of Fortacin spray, yields 22.5 mg of lidocaine and 7.5 mg of prilocaine. Each bottle of Fortacin contains 150mg/ml of lidocaine and 50mg/ml of prilocaine.
When used according to the manufacturer's guidelines, Fortacin spray is safe for most men.
According to clinical safety data, systematic exposure to prilocaine and lidocaine metabolites remain low even when more than the recommended dose is used.
Both male subjects using the product and female volunteers who directly applied Fortacin spray to their genitals had low plasma levels after application.
Unfortunately, there has not been clinical analysis to determine if Fortacin is safe for people of all ages. Safety and efficacy for people who are over the age of 65 has also not been established.
Nevertheless, adverse reactions are a possibility with Fortacin spray use for premature ejaculation.
In clinical trials mentioned in the clinical safety data, however, less than one percent of study participants discontinued treatment due to adverse reactions.
There is also a chance of experiencing an allergic reaction to the ingredients in Fortacin. If you have a history of sensitivity to local anesthetics, you should not use this product.
The same applies if a user’s partner has experienced allergic reactions to prilocaine, lidocaine, or other Fortacin ingredients in the past.
According to the aforementioned clinical safety data, the two most common side effects include over-desensitization (4.5%) and erectile dysfunction (4.4%).
A burning sensation in the penis was also common with use. Other side effects that are uncommon include:
Female partners may also experience adverse reactions with exposure. Almost four percent of female partners reported genital burning sensations and one percent reported over-desensitization.
Other side effects were uncommon but possible for female partners, including:
Fortacin should be used only under a doctor's guidance if someone is already using other topical treatments or taking certain medications.
Methemoglobinemia may be a bigger risk if the user is concurrently using medication that is also related to the condition, such as:
Also, even though specific studies have not yet been conducted, it is advised to use Fortacin with caution if antiarrhythmic medications like mexiletine or amiodarone are being taken.
The manufacturer also says that beta-blockers may reduce the rate at which lidocaine is cleared from the body.
This could generate problems with toxic buildup if using high doses of Fortacin in a short time frame. However, with standard topical use, this should not be an issue.
The EMA guidelines for Fortacin spray explicitly state that a small amount of the medication may indeed be transferred to a partner during intercourse.
As noted above, clinical trials results did show that female partners of male study participants experienced some side effects while their partner used the spray.
For example, a common reported side effect was genital burning and another was genital desensitization.
With all this considered, there may be a greater risk of partner transference with Fortacin than some other delay sprays.
However, there has not been enough formal research into the topic with other options to make definitive statements.
Fortacin's manufacturers do not state whether the product can be used during oral sex.
However, the guidelines from the EMA do state that there is a chance the product can affect other "mucous membranes," which would include the mouth, throat, and nose.
The guidelines further state that numbness may last a "short while." And, if numbness occurs in the mucosal membranes, caution should be taken to avoid injury.
In the event Fortacin is used during oral sex, the penis should be washed thoroughly to lower the risk of oral transference.
Fortacin delay spray should not be used with polyurethane condoms. The prilocaine and lidocaine may deteriorate the material and make them ineffective.
Fortacin use during pregnancy should be avoided to deter the possibility of fetal exposure.
The guidelines state avoidance during pregnancy just as a precaution; no fetal toxicity has been reported.
And, while there are no substantial human studies to show Fortacin affects the quality or motility of sperm, animal studies have shown the product to slow sperm motility.
Therefore, Fortacin should not be thought of as a contraceptive, but may need to be avoided if someone is trying to conceive.
Fortacin is a topical spray applied to the penis that is prescribed for the treatment of PE throughout Europe. This prescribed delay spray may soon be available in the U.S.
Fortacin has been extensively studied and been shown to be effective at delaying ejaculation and enhancing sexual satisfaction.
However, because the spray is a combination of lidocaine and prilocaine, a heightened chance of certain adverse side effects may be possible.
While Fortacin may eventually be an option, over-the-counter delay sprays like Promescent have been shown to be just as effective. And, Promescent is available without a visit to the doctor.
Our team has over a decade of experience in the sexual wellness field and are experts in sexual dysfunctions, like premature ejaculation. We help couples and individuals better understand treatment options available for different types of sexual needs and educate the public on all things related to intimacy. All of our authored content is medically reviewed for accuracy and reliability.
Absorption Pharmaceuticals LLC (Promescent) has strict informational citing guidelines and relies on peer-reviewed studies, academic or research institutions, medical associations, and medical experts. We attempt to use primary sources and refrain from using tertiary references and only citing trustworthy sources. Each article is reviewed, written, and updated by Medical Professionals or authoritative Experts in a specific, related field of practice. You can find out more about how we ensure our content is accurate and current by reading our editorial policy.
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Dinsmore WW, Wyllie MG. PSD502 improves ejaculatory latency, control and sexual satisfaction when applied topically 5 min before intercourse in men with premature ejaculation: results of a phase III, multicentre, double-blind, placebo-controlled study. BJU Int. 2009 Apr;103(7):940-9. doi: 10.1111/j.1464-410X.2009.08456.x. Epub 2009 Feb 23. PMID: 19245438. Accessed on Nov, 18, 2022.
Carson C, Wyllie M. Improved ejaculatory latency, control and sexual satisfaction when PSD502 is applied topically in men with premature ejaculation: results of a phase III, double-blind, placebo-controlled study. J Sex Med. 2010 Sep;7(9):3179-89. doi: 10.1111/j.1743-6109.2010.01913.x. PMID: 20584124. Accessed on Nov, 18, 2022.
Boeri L, Pozzi E, Fallara G, Montorsi F, Salonia A. Real-life use of the eutectic mixture lidocaine/prilocaine spray in men with premature ejaculation. Int J Impot Res. 2022 Apr;34(3):289-294. doi: 10.1038/s41443-021-00424-9. Epub 2021 Apr 7. PMID: 33828264. Accessed on Nov, 18, 2022.
Beecham, Gabriel B., et al. “Lidocaine.” Nih.gov, StatPearls Publishing, 19 Dec. 2021, www.ncbi.nlm.nih.gov/books/NBK539881/. Accessed on Nov, 18, 2022.
"Lidocaine/prilocaine: Basics, Side Effects & Reviews - GoodRX." Goodrx.com, 2021, www.goodrx.com/lidocaine-prilocaine/what-is. Accessed on Nov, 18, 2022.
"Fortacin (Lidocaine/Prilocaine) Spray - New Medicine Review." Lancsmmg.nhs.uk, 2019, www.lancsmmg.nhs.uk/media/1087/fortacin-lidocaine-prilocaine-new-medicine-review.pdf. Accessed on Nov, 18, 2022.
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