LTR Pharma’s ED treatment SPONTAN proves it can last with 18-month shelf life

• LTR Pharma’s SPONTAN nasal spray mist to treat erectile dysfunction achieves 18-month shelf life
• Validates commercial-scale manufacturing and distribution capacity across Australia
• Ongoing stability program provides defined regulatory pathway for extending shelf life further

Special Report: LTR Pharma’s SPONTAN erectile dysfunction (ED) nasal spray has achieved an 18-month shelf life under international stability standards – a key milestone that strengthens commercial prospects in a global ED market forecast to reach US$6 billion by 2028.

LTR Pharma (ASX:LTP) said the achievement demonstrated the robustness of the SPONTAN ED nasal spray formulation, delivery device and packaging system under standard storage conditions.

The 18-month shelf life provides robust commercial flexibility well beyond current distribution requirements  and provides the stability foundation essential for international market entry and partnership discussions.

Major technical milestone

LTR Pharma said achieving extended shelf life was a major technical milestone for a liquid nasal spray formulation.

Unlike oral PDE5 tablets – such as Viagra and Cialis – liquid formulations must maintain active ingredient stability in solution whilst ensuring consistent device performance throughout the shelf life.

SPONTAN has demonstrated chemical stability and device reliability across the full 18 months under International Council for Harmonisation (ICH) conditions.

The latest stability data strengthens SPONTAN’s chemistry, manufacturing and controls (CMC) package, an essential component for regulatory submissions in the US, Europe and Asia.

It also positions SPONTAN competitively against oral PDE5 inhibitors while preserving its key advantage – rapid onset of action within 10 minutes compared to 60+ minutes for tablets.

LTR Pharma’s ongoing stability program is set to continue through 24 months and beyond, with interim data potentially supporting further shelf-life extensions.

Under established regulatory guidelines, manufacturers can extend expiry dates as new stability data becomes available, creating additional commercial flexibility.

‘On track to transform ED treatment worldwide’

It’s been a good week for LTR Pharma which also announced that results of its phase I pharmacokinetic (PK) study of SPONTAN had been published in the peer-reviewed European Journal of Pharmaceutical Sciences.

Executive chairman Lee Rodne said the 18-month stability achievement marked a pivotal step in SPONTAN’s global commercial journey.

“We have proven that our innovative intranasal formulation can meet international distribution standards,” he said.

“This milestone validates our manufacturing strength and positions SPONTAN as a commercially viable alternative to traditional ED treatments.

“With our Australian footprint expanding and a stability profile that meets global expectations, we are on track to transform ED treatment worldwide.

This article was developed in collaboration with LTR Pharma, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.