LTR Locks in FDA Pathway, Fast-Tracks U.S. Expansion with Roxus®
- StockSurge Team
- Mar 25
- 2 min read
LTR Pharma (ASX: LTP) has hit a major regulatory milestone with the U.S. FDA while ramping up its commercial push in the U.S. and Australia.
The company has arranged a pre-Investigational New Drug (pre-IND) meeting for its intranasal erectile dysfunction (ED) treatment, SPONTAN®, and is set to launch Roxus®, a new product designed for early market entry.
Regulatory Pathway for SPONTAN®
LTR Pharma's pre-IND meeting with the FDA mapped out a streamlined path to approval for SPONTAN®. The plan includes one pivotal safety and efficacy trial and a multi-dose pharmacokinetic (PK) study. The agency backed LTR’s toxicology and chemistry, manufacturing, and controls (CMC) development plans, bringing the company closer to a New Drug Application (NDA) submission.
LTR will work with Aptar Pharma and leading contract research organizations (CROs) to fast-track the studies, while also looking to leverage U.S. trial data for other global markets.
U.S. Market Entry with Roxus®
To gain an early foothold in the U.S., LTR Pharma is launching Roxus®, a vardenafil-based nasal spray, via the 503(a)-compounding pharmacy pathway. This market, worth over $6 billion and projected to hit $10 billion by 2033, offers a faster route to commercialization while SPONTAN® moves through FDA approvals.
LTR is co-developing Roxus® with an Australian pharmaceutical partner, with stability and shelf-life testing underway. The Company expects the product to hit the U.S. market in early 2026, providing valuable insights into prescriber behaviour and patient preferences.
Strong Momentum in Australia
SPONTAN® continues to gain traction in Australia, with rising adoption under the Special Access Scheme (SAS) and Authorised Prescriber Scheme (APS). LTR's partnership with the Restorative Sexual Health Clinic (RSHC) launched a telehealth platform in December 2024, receiving strong patient feedback.
LTR has also teamed up with Men’s Health Downunder, Australia’s largest men’s health pharmacy network, and is set to expand through Symbion’s national pharmacy network in Q2 2025.
Scientific Recognition
SPONTAN® made waves at the Urological Society of Australia and New Zealand (USANZ) Annual Scientific Meeting, where LTR’s Chief Scientific and Clinical Adviser, Professor Eric Chung, won the BAUS Trophy for his presentation. Data showed SPONTAN® absorbs 470% faster than oral ED tablets, reinforcing the potential of intranasal drug delivery.
LTR is now working with leading clinicians to publish real-world case studies in peer-reviewed journals, further validating SPONTAN®’s clinical benefits.
Leadership Insight
LTR Pharma Executive Chairman Lee Rodne highlighted the company’s two-pronged strategy:
“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.”
Rodne emphasized LTR’s patient-first approach: “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.”
