ED drug may become OTC

2 minute read

Australian men may soon have access to over-the-counter ED medication


Australian men may soon have access to over-the-counter erectile dysfunction medication for the first time.

The TGA is considering down-scheduling Bayer’s Levitra (vardenafil) from prescription-only to a pharmacist-only drug.

Bayer, which made a formal submission to the TGA, says erectile dysfunction adversely affects sexual intimacy, reduces quality of life and increases the use of healthcare services.

“While erectile dysfunction is not a disease, it is related to physical diseases such as diabetes, and psychological conditions such as depression,” the company said.

“The self-care controlled environment within pharmacy represents an important step forward in providing men with greater accessibility to [vardenafil].”

In its application to the government consultation, Bayer proposed a new schedule 3 entry for vardenafil in oral preparations containing 10mg or less in packs containing not more than eight dosage units.

According to Bayer estimates, ED affects one in five Australian men over the age of 45. However, less than 20% under the age of 65 consult their doctor about ED symptoms, the company says.

Meanwhile, Bayer says the purchase of unapproved ED products online is widespread in Australia, which creates safety issues.

Applications have also been made to the TGA in relation to melatonin, paracetamol compounded with caffeine and a number of other medications.

The government consultations will close on 1 September.

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