LOS ANGELES, Dec. 11, 2013 /PRNewswire/ -- 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.
Promescent was invented in 2009 by Ronald F. Gilbert, former chief of the Department of Urology at Hoag Hospital and assistant clinical professor of Urology at UCI Medical School. Gilbert sought a eutectic formulation with maximum absorption rate through the penile skin without the use of prilocaine. Urologists had been encouraged by the success of two topical anesthetics with lidocaine/prilocaine eutectic formulations: EMLA and PSD502. However, neither of the products are approved by the FDA specifically for the treatment of PE due to prilocaine's unusual side effect of methemoglobinemia. On April 22, 2013, the U.S. Patent and Trademark Office indicated that it would grant a patent to inventors Ronald F. Gilbert and colleagues related to the use of its topical medication, Promescent, for premature ejaculation (PE). The patent, assigned to Absorption Pharmaceuticals, protects novel lidocaine-only eutectic formulation, which enables maximum absorption of the anesthetic through the skin's outer layer. Promescent conforms to 21 CFR Section 348.10 Subpart B (a)(2) and is produced in the United States by a pharmaceutical manufacturing company meeting or exceeding Good Manufacturing Practices (GMP) established by the FDA.
Unlike ionized forms of lidocaine, which may not penetrate skin or may take significant time, Promescent features a eutectic mixture with un-ionized lidocaine to more effectively penetrate the skin membrane. This formula allows men to easily manage penile sensitivity in order to maintain optimum sexual satisfaction with no product transference to their partner. Promescent takes effect in as little as 10 minutes and typically lasts at least 30 minutes to an hour plus, depending upon the dose and pretreated penile sensitivity.
About Absorption Pharmaceuticals
Absorption Pharmaceuticals is the maker of Promescent®, an FDA-approved topical treatment for premature ejaculation and first-line therapy for PE. Based in Huntington Beach, California, with offices in Las Vegas, Chicago, and New York, this privately held company was founded in 2011 and has seen tremendous distribution growth within the U.S. and internationally.
Promescent is now available through doctors' offices, pharmacies and online at http://www.promescent.com.
Promescent is a registered trademark of Absorption Pharmaceuticals.
To set up an interview and/or media inquiries, call Tyler Barnett at 323.937.1951.
SOURCE Absorption Pharmaceuticals