AP, Kaiser Permanente initiate clinical trial to evaluate the efficacy of Promescent lidocaine spray

Dec 11 2013

Absorption Pharmaceuticals LLC (AP) in collaboration with Kaiser Permanente announced today the initiation of a clinical trial to evaluate the efficacy of Promescent lidocaine spray for men with premature ejaculation (PE). This Phase III, double blind, placebo-controlled, randomized study will measure the intravaginal ejaculatory latency time (IELT) for subjects aged 18 and older. The study protocol will adhere to International Society of Sexual Medicine's (ISSM) definition of PE and guidelines set forth by the Standards for Clinical Trials in Male Sexual Dysfunction Committee.

Jeff Abraham, CEO of Absorption Pharmaceuticals, said, "I am very pleased to be engaging in this trial with Kaiser. Although Promescent has already been recognized as a viable solution for PE, obtaining the clinical data resulting from this study is a key step in achieving our goal to be the first-line therapy for this condition by both the AUA and ISSM."

Promescent is a topical spray that is applied to the penis about 10 minutes prior to sexual activity. Its formula contains a patented eutectic absorption technology, enabling the lidocaine to penetrate the penile skin's stratum corneum layer to reach the underlying dermal papillae where the nerves reside that control ejaculation latency. Similar to TEMPE (PSD502) and EMLA, but prilocaine-free, Promescent is the only FDA-approved, topical premature ejaculation product with a lidocaine-only eutectic mixture. Its unique formulation and metered dose delivery system provides superior ejaculatory control with minimal side effects.

"We are very pleased to partner with Absorption Pharmaceuticals to evaluate the efficacy of their product, Promescent. Its lidocaine-only absorption formula shows promise as a universally-accepted solution for PE," says principal investigator and leader of the trail at Kaiser Permanente, Eugene Y. Rhee, M.D., MBA, chief of the Department of Urologic Surgery at the Southern California Permanente Medical Group and president of The California Urologic Association.

The Promescent® trial will be conducted at two Kaiser Permanente Southern California medical centers: Los Angeles and San Diego. Over the course of a year, the study will screen approximately 150 subjects with an estimated 20 percent screen failure rate to produce a total of 120 subjects. Subjects who provide written informed consent, meet all eligibility criteria and are enrolled to the study will be randomized to one of two arms: active treatment (Promescent lidocaine spray) or placebo. Each arm will contain 60 subjects stratified by site.

"Promescent has already established itself within the urology and sexual medicine communities as a first-line therapy for men suffering with PE. The results of this clinical trial will serve to validate what is already known by patients and physicians alike, which is that this product really works," said Laurence A. Levine, M.D., professor and an attending surgeon in the Department of Urology at Rush University Medical Center in Chicago, Sexual Medicine Society of North America (SMSNA) multiple committee chair member, former president of the Chicago Urologic Society, and voted Best Urologists in Chicago by Chicago Magazine.

Premature Ejaculation (PE) continues to be a leading cause of sexual dysfunction among men of all ages, leading to a significant decrease in self-esteem and healthful relationships. Currently, 200 pharmacies and over 1,000 urologists throughout America recommend Promescent's patented, one-of-a-kind formula to aid their patients.