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The Creation and Development of Promescent

by Ronald Gilbert M.D. F.A.C.S.

Urology, as in all other medical specialties, has certain diagnoses for which an adequate solution is elusive. Interstitial cystitis and non-bacterial prostatitis are two of these urological diagnoses. Urologists have historically been challenged to adequately manage these difficult to treat entities. Another condition that has continued to be a treatment challenge and seemed to have no adequate solution or cure was PE. Although PE is widely considered the most prevalent male sexual dysfunction, men who suffer from poor control of ejaculation have not had the treatment options seen in other sexual dysfunctions such as erectile dysfunction.

Ron Gilbert M.D. F.A.C.S. talks about PE and the many misconceptions that surround the #1 men's sexual dysfunction.

 

 

Lidocaine-based Topical Anesthetics Show Promise
Like the majority of my urological colleagues, I had historically treated patients having difficulty delaying ejaculation with serotonin reuptake inhibitors (SSRIs). Although some of my patients have responded very well with this form of therapy, others have found SSRIs to be inadequate either due to the need for daily dosing, medication related side effects or both. Approximately three years ago I happened upon an article in the Journal of Urology detailing the results of patients treated for PE with a prescription topical anesthetic cream. I was initially apprehensive because numerous patients tried inexpensive lidocaine-based topical creams and sprays and results were universally unsatisfactory. However, with the prescription-based anesthetic, the feedback from my patients was generally positive but patients had difficulty controlling the dose and complained that the cream was oily and "messy". I became intrigued by the idea of topical therapy for PE because of the lack of systemic side effects and the ability to use the medication in an on-demand fashion. Additional research towards a cure for PE led to two discoveries that together resulted in our product.

The first document was the monograph released by the FDA in the mid 80's which stated that PE could be treated by either benzocaine or lidocaine applied topically. Although this news was significant, the importance of it was tempered by the fact that neither of these compounds are able to be absorbed through the layer of the skin called the stratum corneum. Therefore, what the FDA had approved for use were substances with suboptimal efficacy.

Ron Gilbert M.D. F.A.C.S. talks about why the topical spray is the best treatment for PE available and how it's a product just as much, if not more, for women as it is for men.

 

 

Discovery of Formula with Good Absorption
The second document was a patent approved from a university in the southern United States. The university conducted research to determine whether an alternative to an off-label, topical anesthetic could be developed. Although this prescription topical anesthetic has excellent efficacy, the prilocaine component can potentially lead to a rare side effect involving oxygen carrying capacity called methemoglobinemia. This problem is potentially catastrophic in children and therefore an alternative that contained only lidocaine would represent a safer alternative. The researchers were successful in developing a clinically-equivalent, lidocaine-only topical anesthetic through a process called a two-step melting point depression process.

Development of Promescent
Using this technology, we at Absorption Pharmaceuticals, in conjunction with pharmacologists at the university, developed Promescent, an exciting new advance in the treatment of PE that is developed using lidocaine alone in conjunction with the FDA monograph. It has been sold by physicians to thousands of patients with PE with excellent patient acceptance and comes as great news to urologists struggling for adequate answers for their patients suffering from PE. Unlike SSRIs, Promescent has no systemic side effects and does not need to be dosed either daily or hours prior to intercourse. Unlike off-label, topical anesthetic creams, Promescent is manufactured in a metered dose bottle. This bottle sprays 130 microliters or 10 mg of lidocaine per each spray, allowing precise dosage reproducibility or adjustability. For patients with PE, this means they can learn how to delay ejaculation to a time that suits the level of his excitement or the desired sexual session with his partner. 

In my quest towards a cure for PE, Promescent is a huge step forward and rapidly becoming the best known solution on the market today.

Ron Gilbert M.D. F.A.C.S. talks about how he developed the FDA approved treatment and why the technology is so unique and effective.