Promescent and PSD 502

The topical spray PSD 502 has yet to receive regulatory approval by the FDA for the treatment of premature ejaculation. This is in spite of multiple studies showing excellent efficacy and no episodes of significant side effects. Because Dapoxetine, the oral agent currently available in several countries is also yet to receive FDA approval, both physicians and patients in North America are in a difficult situation regarding treatment options for what some feel is the most common sexual disorder in men. What made PSD 502 unique among ED treatment options was the fact that unlike other topical therapies containing lidocaine alone, PSD 502 contained eutectic absorption technology that significantly enhanced its efficacy compared to other topical agents. The remaining topical therapies available do not use this technology and have never been shown in clinical studies to be efficacious.

Promescent, a topical, metered dose spray, contains eutectic absorption technology similar to what is seen in PSD 502. However, because Promescent does not contain prilocaine, it is available as an over the counter product under FDA monograph 21 CFR 248. Promescent has many similarities to PSD 502, including the route of administration (metered dose spray), prompt onset of action (10 minutes) and in preliminary clinical experience the product has shown excellent efficacy and minimal side effects. Unlike PSD 502 Promescent is available legally in North America and does not require a prescription. The product is currently nearing the completion of its initial clinical trial being conducted by Dr. Irwin Goldstein, the Editor in Chief of the Journal of Sexual Medicine.