Richard Henry1, Alvaro Morales, Michael G Wyllie. 1. Queen's University, Department of Anesthesiology, Kingston General Hospital, 76 Stuart Street, Kingston, Ontario, K7L 2V7, Canada.
Abstract
BACKGROUND: Premature ejaculation (also known as rapid or early ejaculation) is the most common form of sexual dysfunction experienced by men, but there is presently an unmet need for a licensed pharmaceutical product that can be used on demand and that is effective from the first dose. OBJECTIVE: TEMPE (Topical Eutectic-Like Mixture for Premature Ejaculation; Plethora Solutions Plc.) is a proprietary metered-dose aerosol containing a combination of the well-known local anaesthetics lidocaine and prilocaine in a novel formulation. The authors evaluate here the progress that has been made towards the reformulation of these local anaesthetic agents into a unique eutectic-like formulation for use as a desensitising agent in the treatment of premature ejaculation, as well as examining other potential uses for the spray, such as pain relief at skin-graft donor sites. METHODS: Both lidocaine and prilocaine are soluble in the hydrofluoroalkane (HFA-134a) propellant, providing a unique formulation in which the pressurised liquid propellant is used as the solvent. Deployment of the metered-dose chamber vaporises the propellant, spraying lidocaine and prilocaine, now forced into a eutectic-like combination that remains in liquid form at temperatures well below their individual melting points, onto the target surface. The site is thus easily covered in a controlled dose of pure local anaesthetic in base form, providing ideal circumstances for optimised absorption through non- or poorly-keratinised skin, mucus membranes and wound surfaces. RESULTS/ CONCLUSION: TEMPE has been developed for use in premature ejaculation and preliminary results show promising improvements in intravaginal ejaculatory latency, as well as patient-reported outcomes.
BACKGROUND: Premature ejaculation (also known as rapid or early ejaculation) is the most common form of sexual dysfunction experienced by men, but there is presently an unmet need for a licensed pharmaceutical product that can be used on demand and that is effective from the first dose. OBJECTIVE:TEMPE (Topical Eutectic-Like Mixture for Premature Ejaculation; Plethora Solutions Plc.) is a proprietary metered-dose aerosol containing a combination of the well-known local anaesthetics lidocaine and prilocaine in a novel formulation. The authors evaluate here the progress that has been made towards the reformulation of these local anaesthetic agents into a unique eutectic-like formulation for use as a desensitising agent in the treatment of premature ejaculation, as well as examining other potential uses for the spray, such as pain relief at skin-graft donor sites. METHODS: Both lidocaine and prilocaine are soluble in the hydrofluoroalkane (HFA-134a) propellant, providing a unique formulation in which the pressurised liquid propellant is used as the solvent. Deployment of the metered-dose chamber vaporises the propellant, spraying lidocaine and prilocaine, now forced into a eutectic-like combination that remains in liquid form at temperatures well below their individual melting points, onto the target surface. The site is thus easily covered in a controlled dose of pure local anaesthetic in base form, providing ideal circumstances for optimised absorption through non- or poorly-keratinised skin, mucus membranes and wound surfaces. RESULTS/ CONCLUSION:TEMPE has been developed for use in premature ejaculation and preliminary results show promising improvements in intravaginal ejaculatory latency, as well as patient-reported outcomes.