Premature Ejaculation (PE) is considered to be the most widely prevalent male sexual dysfunction.Â Men who suffer from PE have had minimal treatment options available to this date and have generally been treated with either anti-depressants or topical medications. Both treatment options have been proven to be effective at delaying ejaculation but each have their own set of side effects that have rendered them undesirable.
Anti-depressants in the form of selective serotonin reuptake inhibitors (SSRIs) must be taken daily and, in most men, generate a host of negative side effects including dry mouth, nausea, and, ironically, loss of libido. The only topical medication that has proven effective by the medical community is EMLA which has a eutectic formula created by the combination of lidocaine and prilocaine. A eutectic formula enables the anesthetics to absorb through the penile skin surface to the nerves below that control ejaculation. Many researchers agree that it’s the absorption capability of the eutectic formula that is the key to ejaculatory control.
Because EMLA contains prilocaine, a drug that has a potentially dangerous side effect, it is not approved by the FDA and must be prescribed off-label. A new product with a lidocaine-prilocaine eutectic formula, PSD502, has achieved good ejaculatory control in clinical trials but has not achieved FDA approval because of the existence of prilocaine.
â€œPremature ejaculation is the most universal form of sexual dysfunction, affecting men of every age. But it is also the least understood. Embarrassment and lack of accurate information prevent many men from seeking medical treatment for premature ejaculation, a condition that not only adversely affects them, but also their partners and relationships,” explained board certified urologist Dr. Ronald F. Gilbert in a news release. “And many of those who do seek treatment are dissatisfied with the therapies that have been available to date.”
Absorption Pharmaceuticals set out to develop a topical medication with an absorbing eutectic formula that contains only lidocaine. Given the safety record of lidocaine (also called xylocaine, commonly used by dentists), the formula would adhere to FDA monograph 21CFR 348.10 which allows for the resulting product to be available over-the-counter (OTC). The result of this research and development was Promescent, which enables the lidocaine to absorb through the stratum corneum of the penile skin to the dermis and control ejaculation latency.
The product is typically applied to the penis just 10 minutes prior to sexual activity. It is manufactured in a metered dose bottle that sprays 130 micro liters or 10mg of lidocaine per each spray.Â This enables precise, repeatable dosing and helps patients attain the desired ejaculatory control for their level of sensitivity or adjust the dose depending upon sexual arousal.
Promescent is a breakthrough for urologists who for years have been seeking an effective, safe, on-demand solution for PE. It has been used by thousands of patients and has demonstrated excellent patient acceptance and compliance. As compared to SSRIs or EMLA, the lidocaine-only formula has no systemic side effects and is available OTC. Promescent also has a low cost per application ($1.33 per spray for standard metered dose spray bottle) with the average dose of just 1-3 sprays.
Promescent is replacing SSRIs and EMLA, becoming first-line therapy at an increasing number of urologists across the U.S. Many key opinion leaders in the urology specialty of sexual medicine are recommending the product because of its effectiveness and adherence to the FDA monograph, even without clinical trial data.