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(12) Patent Application Publication (10) Pub. No.: US 2009/0093547 A1 Corbitt Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2009/0093547 A1 Corbitt Et Al US 20090093547A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2009/0093547 A1 Corbitt et al. (43) Pub. Date: Apr. 9, 2009 (54) COMPOSITIONS AND METHODS FOR Publication Classification TREATING PREMATURE EACULATION (51) Int. Cl. (75) Inventors: James M. Corbitt, Tucker, GA st 4. CR (US); Brian Adams, Atlanta, GA ( .01) (US); Larry Dillaha, Atlanta, GA (52) U.S. Cl. ........................................................ 514/626 (US) Correspondence Address: (57) ABSTRACT Pabst Patent Group LLP 1545 PEACHTREE STREET NE SUTE 32O Compositions and methods for the treatment of premature ATLANTA, GA 30309 (US) 9 ejaculation have been developed. It has been discovered that 9 premature ejaculation can be treated by administering a local (73) Assignee: Sciele Pharma, Inc. anesthetic to the glans penis. The local anesthetic may be formulated as an emulsion, lotion, paste, gel, cream, oint (21) Appl. No.: 11/869,280 ment, shea butter, Suspension, Solution, balm, salve, foam, or in the form of a pump spray to achieve local anesthesia of the (22) Filed: Oct. 9, 2007 dorsal neurons of the penis. US 2009/0093547 A1 Apr. 9, 2009 COMPOSITIONS AND METHODS FOR 0007. There exists a need for improved alternatives for the TREATING PREMATURE EACULATION effective treatment of PE. 0008. Therefore, it is an object of the invention to provide FIELD OF THE INVENTION compositions for the effective treatment of PE and methods of use thereof. 0001 Compositions and methods for treating premature 0009. It is another object of the invention to provide local ejaculation have been developed, which are useful for desen compositions containing an effective amount of one or more sitizing the dorsal nerves of the penis. local anesthetics to cause desensitization of the neurons of the glans penis and methods of making and using thereof. BACKGROUND OF THE INVENTION SUMMARY OF THE INVENTION 0002 Premature ejaculation (PE) remains the most com 0010 Compositions for the treatment of premature ejacu mon sexual dysfunction in men. Although progress is being lation (i.e. to delay or have control over ejaculation) and made in elucidating its causal mechanisms, the disparate Vari methods of making and using thereof have been developed. ety oftechniques and drugs available for its treatment has met The compositions contain an effective amount of one or more only limited Success. For instance, behavioral interventions anesthetics for local administration to the glans penis. The were reported to be effective with initially satisfactory results compositions may be formulated as an emulsion, lotion, in the vicinity of 90%; unfortunately, the success rates decline paste, gel, cream, ointment, shea butter, Suspension, Solution, markedly to less than 25% after 3 years. Systemic drugs have balm, salve, foam, or pump spray to achieve local anesthesia proven to have varying levels of efficacy, but are plagued by of the dorsal neurons of the penis. side effects that are generally considered unacceptable, in the 0011. The compositions may further contain one or more long term, in otherwise healthy men. Equally discouraging, additional pharmaceutically active agents. Suitable classes of the effect of these medications is temporary since the Symp active agents include, but are not limited to, antimicrobial toms return upon their discontinuation. agents (antibacterial and antifungal agents, and/or antiproto 0003. The early Freudian-based causal hypothesis of PE Zoal agents), anti-inflammatory agents (non-steroidal or Ste has been revised and largely abandoned in favor of physi roidal agents), vasodilator agents, anti-oxidants, vitamins, ological facts. A heightened sensitivity of the glans to tactile and hormones. stimuli is currently believed to be a fundamental initiating factor in PE. Therefore, it is possible that reducing the sensi DETAILED DESCRIPTION OF THE INVENTION tivity of the glans could translate into a delaying effect on intravaginal ejaculation latency time (IVELT) without I. Definitions adversely affecting the sensation of ejaculation. A drastic 0012 “Water soluble' as used herein refers to substances approach to desensitization involves “neurotomy' of the dor that have a solubility of greater than or equal to 5 g/100 ml sal nerves of the penis. This invasive and irreversible measure Water. is reported to be effective but has failed to gain wide support 0013 “Lipid soluble' as used herein refers to substances in the medical community. that have a solubility of greater than or equal to 5 g/100 ml in 0004 Topical formulations for the treatment of PE have a hydrophobic liquid Such as castor oil. also been evaluated. Stud 100R) (available from Pound Inter 0014) “Hydrophilic” as used herein refers to substances national, Ltd, England), an over the counter formulations that have strongly polar groups that readily interact with containing 9.6% w/v lidocaine HCl, is marketed as a treat Water. ment for PE. This product contains an ionized form of 00.15 "Lipophilic” as used herein refers to compounds lidocaine in order to increase the solubility of the lidocaine in having an affinity for lipids. the delivery vehicle at physiological pH. However, lidocaine 0016 Amphiphilic” as used herein refers to a molecule salts do not effectively penetrate keratinized and non-kerati combining hydrophilic and lipophilic (hydrophobic) proper nized skin. Thus, this product is considered to be ineffective ties for the treatment of PE. In fact, no controlled clinical trials 0017 “Hydrophobic' as used herein refers to substances have been conducted showing that this product is effective for that lack an affinity for water; tending to repel and not absorb the treatment of PE. water as well as not dissolve in or mix with water. 0005 Xylocalne(R), a lidocaine spray, is used primarily for 0018. As used herein, an “oil is a liquid or liquefiable the treatment of Sore throats. Xylocalne contains ethanol as a material that is immiscible in water. In one embodiment, an Solvent and dichloroethane and trichloroethane as propel oil is a composition containing at least 95% by weight of a lants. Xylocalne is not ideal for use in topical applications lipophilic Substance. Exemplary lipophilic Substances because the propellants can cause irritation of the mucosal include, but are not limited to, naturally occurring and Syn membranes, such as the glans penis. thetic oils, fats, fatty acids, lecithins, triglycerides and com 0006 EMLA, a cream containing a local anesthetic, may binations thereof. be an alternative treatment for PE. However, the active ingre 0019. As used herein, an "emulsion' is a composition dients of EMLA take a long time to penetrate the glans so that containing a mixture of non-miscible components homog the formulations would need to be applied well in advance of enously blended together. In particular embodiments, the sexual activity, which can limit spontaneity. Further, the non-miscible components include a lipophilic component cream is greasy, difficult to administer, and requires the use of and an aqueous component. An emulsion is a preparation of a condom in order to prevent partner transfer. Finally, as one liquid (e.g., the discrete or discontinuous phase) distrib EMLA penetrates keratinized skin, it numbs the whole of the uted in Small globules throughout the body of a second liquid penis, not just the glans, which can compromise sexual sat (e.g., the continuous phase). When oil is the dispersed liquid isfaction. and an aqueous Solution is the continuous phase, it is known US 2009/0093547 A1 Apr. 9, 2009 as an oil-in-water emulsion. When water or an aqueous solu 0024. As used herein, a “cream' is an emulsion having a tion is the dispersed phase and oil or oleaginous Substance is viscosity of greater than 1000 centistokes, typically in the the continuous phase, it is known as a water-in-oil emulsion. range of 20,000-50,000 centistokes. Either or both of the oil phase and the aqueous phase may 0025. As used herein, a “paste’ is a liquid or emulsion contain one or more surfactants, emulsifiers, emulsion stabi having solid material homogenously suspended therein, typi lizers, buffers, and other excipients. Preferred excipients cally in a lotion cream or gel. include Surfactants, especially non-ionic Surfactants; emulsi 0026. As used herein, a “gel’ is a composition containing fying agents, especially emulsifying waxes; and liquid non a thickening agent or polymeric material dissolved or Sus Volatile non-aqueous materials, particularly glycols such as pended in a liquid. The liquid may include a lipophilic com propylene glycol. The oil phase may contain other oily phar ponent, an aqueous component or both. Some emulsions may maceutically approved excipients. For example, materials be gels or otherwise include a gel component. Some gels, however, are not emulsions because Some do not contain a Such as hydroxylated castor oil or sesame oil may be used in homogenized blend of immiscible components. the oil phase as Surfactants or emulsifiers. 0027 “Penetration enhancers', are used herein, refers to 0020. As used herein, “emollients' are an externally materials or techniques which promote transdermal delivery applied agent that softens or soothes skin. Emollients are of drugs across the skin, in particular across the stratum generally known in the art and listed in compendia, Such as corneum. These can be chemical penetration enhancers or the “Handbook of Pharmaceutical Excipients', 4' Ed., Phar physical penetration enhancers, such as ultrasound. maceutical Press, 2003.
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