New for premature ejactualation

[hoosierphilly]

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended authorization of lidocaine/prilocaine Plethora for the treatment of primary premature ejaculation in men.
The product, manufactured by Plethora Solutions, Ltd, is a cutaneous spray containing a mixture of 150 mg lidocaine and 50 mg prilocaine per milliliter. The anesthetic combination blocks transmission of nerve impulses in the glans of the penis, resulting in reduced stimulation and delay in ejaculation time.
It will be available by prescription only.

The CHMP evaluated data from a clinical trial in which men with premature ejaculation were randomly assigned to receive either lidocaine/prilocaine Plethora or placebo. The topical anesthetic improved ejaculatory control during sexual intercourse, sexual satisfaction, and reduced distress related to ejaculation. Time to ejaculation was increased by 2.59 minutes (going from 0.58 to 3.17 minutes), in contrast to a negligible 0.38-minute increase (going from 0.56 to 0.94 minutes) in the placebo group.

Adverse effects included hypoesthesia and a genital burning sensation in both the men and their female partners. Erectile dysfunction was also seen in the male participants, and female partners experienced headache, influenza, nasopharyngitis, and vulvovaginal discomfort. Nonetheless, the CHMP deemed the benefits of the medicine to outweigh the risks after reviewing data on quality, safety, and efficacy.

As part of the marketing authorization, Plethora Solutions will be required to implement a pharmacovigilance plan.

The EMA is expected to issue its decision within 67 days from adoption of the CHMP's opinion.