Absorption Pharmaceuticals (AP) in collaboration with Kaiser Permanente has started a double blind, placebo-controlled, randomised Phase III clinical trial to assess the efficacy of 'Promescent lidocaine spray' for men with premature ejaculation (PE).
The trial is aimed at measuring the intravaginal ejaculatory latency time (IELT) for subjects aged 18 and older, will adhere to International Society of Sexual Medicine's (ISSM) definition of PE and guidelines set out by the Standards for Clinical Trials in Male Sexual Dysfunction Committee.
Promescent is a topical spray containing a patented eutectic absorption technology, allowing 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.
It is the only FDA-approved, topical premature ejaculation product with a lidocaine-only eutectic mixture.
According to the company, the prilocaine-free Promescent's formulation and metered dose delivery system offers superior ejaculatory control with minimal side effects.
Absorption Pharmaceuticals CEO Jeff Abraham said: "Although Promescent has already been recognised 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."
The trial will be carried out at two Kaiser Permanente Southern California medical centres in Los Angeles and San Diego, US.
Over the course of a year, the trial will screen about 150 patients with an estimated 20% screen failure rate to produce a total of 120 patients.
Patients who provide written informed consent, meet all eligibility criteria and are enrolled in the trial will be randomised to one of two arms (each containing 60 subjects) for active treatment with Promescent lidocaine spray or placebo.
The spray was discovered in 2009 by Ronald Gilbert, former chief of the Department of Urology at Hoag Hospital and assistant clinical professor of Urology at UCI Medical School.
In April, the US Patent and Trademark Office also announced that it would award a patent to inventors Gilbert and colleagues for the use of its topical medication, Promescent, for PE.
The patent is assigned to Absorption Pharma, and will help protect the lidocaine-only eutectic formulation that enables maximum absorption of the anesthetic through the skin's outer layer.
Image: Promescent is FDA Approved Treatment for Premature Ejaculation. Photo: courtesy of PRNewsFoto/Absorption Pharmaceuticals.