LTR Pharma Limited (ASX:LTP) Advances Multi-Market Strategy with FDA Milestone and Roxus Launch
Regulatory Milestone: FDA Pre-IND Meeting
LTR Pharma successfully completed a pre-Investigational New Drug meeting with the US Food and Drug Administration, aligning on a streamlined clinical development path for SPONTAN®. The FDA endorsed the company’s non-clinical and CMC development plans, providing clear guidelines for approval in the US.
US Market Strategy: Launching Roxus®
The company is introducing Roxus®, a vardenafil-based nasal spray, to accelerate entry into the US personalised healthcare sector. Roxus® will be delivered via the 503(a)-compounding pharmacy pathway, targeting the US compounding pharmacy market valued at over US$6 billion. Early US sales are targeted for early 2026.
Australian Market Expansion
LTR Pharma is experiencing strong clinical adoption in Australia, with a growing number of prescribers under the SAS and APS schemes. The company has expanded its telehealth platform and partnered with Men’s Health Downunder and Symbion’s national pharmacy network to enhance distribution.
Scientific Recognition
SPONTAN® received acclaim at the USANZ Annual Scientific Meeting, where Professor Eric Chung was awarded the BAUS Trophy for showcasing SPONTAN’s 470% faster absorption compared to oral ED tablets. The company is collaborating with clinicians to publish real-world case studies on SPONTAN’s efficacy and safety.
Executive Comments
LTR Pharma Executive Chairman, Lee Rodne, stated: “Our positive FDA pre-IND meeting has provided regulatory clarity while unlocking immediate and mid-term commercial opportunities in the US. As SPONTAN moves through the formal FDA process, Roxus offers a fast-track pathway to serve patients through personalised care channels. Nearly 50% of men discontinue oral ED medications due to lack of personalisation. Our approach focuses on clinical collaboration, not just convenience. By empowering healthcare professionals to guide treatment, we offer patients a holistic experience grounded in real care. The response to SPONTAN, both clinically and scientifically, affirms the value of our innovative delivery method. We’re building a robust, multi-market commercial model that maximises short-term returns and long-term potential. First US sales are targeted for early 2026, with a strong foundation already in place.”
Motley Fool contributor Lauren Surplice has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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