26 March 2025 – LTR Pharma Limited (ASX:LTP) (“LTR Pharma” or “the Company”) is pleased to provide an update to the Company’s commercial and regulatory processes, highlighting the strong progress that has been made toward the global commercialisation and approvals for its innovative intranasal erectile dysfunction (ED) treatment, SPONTAN®.
Highlights
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Successful FDA pre-IND meeting has outlined a clear approval pathway for SPONTAN® in the United States.
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Introduction of new product, Roxus®, a vardenafil-based nasal spray targeting the personalised healthcare market via US compounding pharmacy channel.
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Recognition at USANZ conference – SPONTAN® has been shown to deliver 470% faster absorption than traditional oral tablet treatments for erectile dysfunction.
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Investor webinar taking place on Thursday, 27 March 2025 at 10:30am AEDT / 7:30am AWST via Zoom
LTR has successfully completed a pre-Investigational New Drug (pre-IND) meeting with the United States Food and Drug Administration (FDA). The meeting has seen an FDA endorsement of the Company’s non-clinical (toxicology) and Chemistry, Manufacturing and Controls (CMC) plans. The FDA also confirmed a streamlined clinical pathway, including a pivotal safety and efficacy trial.
LTR will work closely with Aptar Pharma and expert Contract Research Organisations (CROs) to complete the required studies and prepare for a formal New Drug Application (NDA) submission.
INtroduction of Roxus®
LTR Pharma is preparing to launch Roxus®, a vardenafil-based nasal spray, into the US 503(a) compounding pharmacy market. This is a sector valued at over US$6 billion, projected to reach US$10 billion by 2033.
Roxus® is being developed with an Australian pharmaceutical partner, and stability testing is now underway. The first US release is now targeted for the first half of the 2026 calendar year. This strategy allows LTR Parma to:
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Establish early commercial presence in the U.S.
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Gain insights into patient preferences and potential pricing strategies.
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Support prescriber engagement while SPONTAN® progresses through to an FDA approval.
SPONTAN® was also recently showcased at the Urological Society of Australia and New Zealand (USANZ) Annual Scientific Meeting, where Chief Scientific and Clinical Adviser, Professor Eric Chung, received the prestigious BAUS Trophy.
The presentation showed that SPONTAN achieves 470% faster absorption than oral ED tablets.
Investor Webinar
LTR Pharma will host an investor webinar to provide a corporate update and address shareholder questions
Date: Thursday, 27 March 2025
Time: 10:30am AEDT / 7:30am AWST
Registration: https://janemorganmanagement-au.zoom.us/webinar/register/WN_6z1q3Ta7SX2FdJZYZ93QSw
Shareholders and attendees are encouraged to submit questions in advance by emailing: [email protected]
About us:
About LTR Pharma (ASX:LTP)
LTR Pharma is dedicated to improving men’s health—physically and mentally—through the commercialisation of innovative treatments for erectile dysfunction. The Company’s lead product, SPONTAN®, delivers a PDE5 inhibitor via a fast-acting intranasal spray, enabling onset of action in 10 minutes or less. This unique delivery method offers men greater control, spontaneity, and confidence, distinguishing SPONTAN® from conventional oral therapies.
LTR Pharma is focused on building a global footprint, leveraging regulatory milestones, strategic partnerships, and medical community engagement to address unmet patient needs.
Contact details:
Jane Morgan
Jane Morgan Management
Investor & Media Relations
[email protected]
