LTR Pharma Strengthens SPONTAN Market Readiness With Extended Shelf Life
LTR Pharma (ASX: LTP) has extended the shelf life of its SPONTAN intranasal erectile dysfunction (ED) spray to 18 months, a milestone that strengthens its commercialisation prospects in Australia and key international markets.
The achievement, confirmed under International Council for Harmonisation stability conditions, demonstrates both chemical and device reliability across the extended period.
It positions SPONTAN to meet and exceed global distribution standards, supporting regulatory submissions and partnership discussions in the US, Europe, and Asia.
Shelf Life Extension
The 18-month shelf life surpasses current requirements for LTR’s growing Australian pharmacy network and provides a foundation for global commercial entry.
The company will continue stability studies through 24 months and beyond, with the potential to extend expiry dates further under established regulatory pathways.
LTR has already commenced discussions with distributors about incorporating the longer-dated product into existing supply agreements.
Executive chair Lee Rodne said the achievement was “a pivotal step in SPONTAN’s global commercial journey,” validating both its manufacturing strength and its competitiveness against oral treatments.
The company said the result underscores the scalability of its production model as it prepares for larger batch manufacturing.
Technical Significance
Extended shelf life is particularly challenging for liquid nasal spray formulations, which must maintain active ingredient stability in solution while preserving device performance.
SPONTAN’s success demonstrates the robustness of its formulation and packaging system, providing a competitive edge over oral phosphodiesterase type 5 (PDE5) inhibitors such as Viagra and Cialis.
The data supports compliance with international Good Manufacturing Practice standards, strengthening the company’s regulatory portfolio, and also improves distribution economics by allowing more efficient stock management across multiple geographies.
LTR said the results strengthen SPONTAN’s Chemistry, Manufacturing and Controls package, a key regulatory requirement for market approvals.
Clinical Validation
The shelf life achievement builds on clinical data published just days earlier in the European Journal of Pharmaceutical Sciences that confirmed SPONTAN achieves peak plasma concentration in a median of 10 minutes, compared to 45 minutes for oral tablets.
Professor Geoff Strange, LTR’s chief medical officer, said the findings addressed the spontaneity challenge that drives half of all ED patients to discontinue oral treatments within their first year.
The publication also validated SPONTAN’s pharmacokinetic profile under rigorous peer review, adding credibility to its clinical package.
LTR noted the results provide an important differentiator in physician engagement, particularly among specialists seeking alternatives for patients who do not respond well to tablets, and said the combined milestones of shelf life extension and peer-reviewed clinical validation have enhanced discussions with potential pharmaceutical partners.
Commercial Positioning
Together, the extended stability and validated rapid onset highlight SPONTAN’s potential to transform the ED market, forecast to reach US$6 billion by 2028, while the favourable stability profile could lower barriers to entry with pharmacy chains that require extended expiry for stocking.
Mr Rodne said the company was “on track to transform ED treatment worldwide” with a technology that now meets both clinical and commercial benchmarks, and the company has already begun engaging with urology and sexual health clinics to ensure early adoption in key markets.
LTR expects continued stability data to support further expiry extensions, providing flexibility for international distribution, and said it is targeting first European market entry in 2026, with the US and Asia to follow pending regulatory approvals.
The company will also pursue expanded clinical adoption through physician engagement and regulatory filings backed by its European journal publication and plans to expand manufacturing capacity over the next 12 months to align with anticipated global demand.