TEMPE: Topical Eutectic-Like Mixture for Premature Ejaculation.

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.