EMA Panel Backs Anesthetic Spray for Premature Ejaculation in Adults

Megan Brooks

September 20, 2019

At its September meeting, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) recommended approval of a new treatment to address premature ejaculation in adult men.

The product, called Senstend (Plethora Pharma Solutions Ltd), is a spray solution containing lidocaine and prilocaine.

Lidocaine and prilocaine block the transmission of nerve impulses in the glans of the penis. This reduces stimulation and helps delay ejaculation time and allow satisfactory sexual activity, the EMA said in a statement.

"The benefits with Senstend are its ability to provide improvements in ejaculatory control and sexual satisfaction and a reduction in distress related to ejaculation," the EMA said.

The most common side effects in men using Senstend are hypoesthesia and erectile dysfunction, while the most common side effects in female sexual partners are hypoesthesia and a burning sensation in the genital area.

The application for Senstend was an informed consent application, which makes use of data from the dossier of a previously authorized medicine. The reference product for Senstend is Fortacin.

Further recommendations and details will be published in the European public assessment report after the European Commission makes a decision about whether to grant full marketing authorization.

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