Absorption Pharmaceuticals, the maker of the world's first FDA-approved topical medication for premature ejaculation, has announced that the U.S. Patent and Trademark Office has indicated that it will grant a patent related to the use of the drug, Promescent.
The patent protects novel lidocaine-only eutectic formulation, which enables maximum absorption of the anesthetic through the skin's outer layer and provides men with improved ejaculatory control while maintaining great sensory feeling.
Absorption Pharmaceuticals, which is based in Huntington Beach, California, was founded in 2011 by the late Dr. Ronald F. Gilbert, former chief of the Department of Urology at Hoag Hospital and assistant clinical professor of urology at UCI Medical School.
For many years, Dr. Gilbert had been treating PE patients with topical anesthetics with modest success. Although effective in slowing the ejaculatory response, these simple lidocaine and benzocaine topical sprays and creams had two side effects which made them undesirable for repeated use by patients: significant loss of sexual sensation and transference of the anesthetic to the man's partner.
"About a decade ago, some urologists started to prescribe EMLA, a prescription topical anesthetic that achieves a eutectic formula, and somewhat better absorption, with the combination of lidocaine and prilocaine," said Dr. Laurence Levine, professor in the Department of Urology at Rush University Medical Center.
"EMLA showed improved performance in controlled studies over simple lidocaine formulas. However, because EMLA contains prilocaine, it lacks FDA approval for treating PE patients and is usually prescribed off-label," Dr. Levine.
Not satisfied with EMLA as a PE treatment, Dr. Gilbert sought a fast-acting, lidocaine-only topical medication with superior skin absorption capability, no loss of penile sexual sensation, elimination of partner transfer, and minimal side effects.
After five years of analysis and laboratory work, Dr. Gilbert and colleagues developed a formulation containing lidocaine, thymol and ethanol in specific ratios that improved EMLA's eutectic absorption effect. This novel formulation also achieved the maximum absorption rate of lidocaine through penile stratum corneum (skin's outer layer), and thus attained maximum anesthetic effect, but retained great sensory feeling.
Virtually no transfer of the anesthetic effect to the patient's partner has been reported, and prilocaine side effects have been eliminated. The secret to the new formulation lies in the strict proprietary balance of ingredient concentrations that maximized the effect of lidocaine's anesthetic efficacy.
Available over-the-counter under FDA Monograph 21 CFR 348.10, Promescent is gaining acceptance by urologists and general practitioners across the U.S.
The award of this patent strengthens Absorption Pharmaceuticals position as a leader in the treatment of premature ejaculation. (ANI)