Erectile nasal spray that works in five minutes set to disrupt Viagra
Viagra revolutionised the treatment of erectile dysfunction, but a major issue with the drug – how long it takes to work – could be solved.
It’s been 25 years since Viagra revolutionised the treatment of erectile dysfunction and provided millions of men the possibility of enjoying a functional sex life. But there’s one problem with the drug and its suite of similar medications known as PDE5 inhibitors - they take a long time to work, and for some men, they don’t work too well at all.
Viagra and similar drugs are taken as an oral pill, and men are advised to ingest the medication about one hour before they plan to have sex. That pretty much rules out any spontaneity. And the effect of the drug depends on what you might have eaten that day and how your body metabolises medication.
But in what may turn out to be the biggest advance in erectile dysfunction treatment since the advent of Viagra, it may soon be possible to take a PDE5 inhibitor as a nasal spray. That would mean it would kick in as little as five minutes.
“Our nasal delivery bypasses the digestive system so it really goes straight in to the bloodstream, and has an effect in five to 15 minutes,” says Lee Rodne, the executive chairman of Brisbane-based biotech LTR Pharma. “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.”
LTR Pharma’s new therapy, dubbed SPONTAN, repurposes the PDE5 inhibitor Vardenafil, which is now off-patent and has high efficacy, as a nasal spray. It is undergoing an expedited regulatory process in the US and will be assessed based on the clinical trial data of other PDE5 inhibitors. A clinical trial will soon begin in Australia comparing SPONTAN with oral delivery of a different PDE5 inhibitor after ethics approval was granted.
Patient recruitment is expected second half of this year, with trial sites set to be opened in Sydney. Results are expected early next year, and if it is approved, SPONTAN would be available to the public in the US within two years. The company would then apply for approval in Australia and other countries.
“We have very high confidence,” Mr Rodne said. “This product has already had a small proof of concept clinical study in California that showed a fast acting rapid onset effect.”
The Royal Australian College of GPs reports that erectile dysfunction (ED) is a very common clinical problem managed in the general practice setting. It can contribute to relationship breakdowns and mental health issues. It’s estimated the condition will affect around 40 per cent of men, with the prevalence increasing with age. PDE5 inhibitors are a frontline treatment for ED.
Brisbane-based LTR Pharma is a spin-off of the medical device commercialisation and distribution company LTR Medical Pty Ltd.
Its scientists collaborated with Californian founding researcher Professor Moses Chow, who first developed the proprietary compound as a nasal spray to treat patients with ED.
The development follows other common medicines moving to the more effective nasal spray delivery method, disrupting pharma markets.