A man uses a nasal spray
Posed by model (Photo: Shutterstock)

Scientists in Australia claim to have created a new treatment for erectile dysfunction that can be administered via a nasal spray. They say its main advantage is that, unlike tablets, it can take as little as five to 15 minutes to take effect.

Common medications for erectile dysfunction include sildenafil (better known under the brand name Viagra) and tadalafil (Cialis).

Once taken, the tablets can take 30-60 minutes before eliciting their desired effect. This is not so great if a spontaneous opportunity for sex arises (or fails to arise, so to speak).

“Our nasal delivery bypasses the digestive system, so it really goes straight into the bloodstream and has an effect in five to 15 minutes,” Lee Rodne, executive chairman of biotech company LTR Pharma, told The Australian on Monday.

“We expect it to be a lot more effective than oral tablets so that it works consistently and in a quicker and faster amount of time, so men don’t have to plan ahead and they don’t have variable results.”

The Australian nasal spray has the name SPONTAN. The active ingredient is Vardenafil (also known by the brand name Levitra). It acts in the same way as sildenafil. It increases blood flow to the penis when you’re sexually aroused. A preliminary proof-of-concept study undertaken in California illustrated how quickly SPONTAN acts.

Fast-track approval sought

According to a press statement from LTR Pharma, the company has “today secured Ethics Approval for a bio-equivalence clinical study of its intranasal spray for erectile dysfunction (ED), ‘SPONTAN™’ – a crucial step in fast-tracking approval for this world-first product with the U.S. Food and Drug Administration (FDA).”

The company says ED impacts approximately 30 million people in the US alone.

“We are thrilled to have received ethics approval for this pivotal clinical study,” said Mr. Rodne in the statement.

LTR Pharma says that it will be seeking out trial participants in Sydney later this year. It’s also already applying to the FDA to be considered for expedited approval. It can apply for this fast-track process because the FDA has already approved Vardenafil in the past. Approving a change in the method of administration should be a quicker process than seeking approval for a new drug.

If SPONTAN is found to be safe and effective, it could be available in a couple of years.

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