30 June 2025 – Sydney, Australia | LTR Pharma Limited (ASX:LTP), a Australian company developing a novel intranasal treatment for erectile dysfunction (SPONTAN®), is pleased to announce that it has achieved its latest regulatory milestone for SPONTAN® with the successful completion of extractables testing and the launch of its leachables studies.
Highlights:
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Extractables study completed with co-development partner Aptar Pharma.
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All identified compounds found to be below ICH safety thresholds.
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Leachables study is now underway to support FDA submission under real-world storage conditions.
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These are significant regulatory milestones, and are crucial to the upcoming FDA 505(b)(2) regulatory submission.
Conducted with global partner Aptar Pharma, the extractables study assessed the bottle and pump for the container closure system used to package and dispense SPONTAN’s solution. All of the compounds detected were well below the safety thresholds defined by the requirements of the International Council for Harmonisation (ICH), and adopted by the U.S. FDA (as well as several other regulators). The outcome of this study supports the safety profile of SPONTAN’s packaging requirements and will enable progression to the next stage of testing required.
The leachables study is now underway, which is also to be managed by Aptar Pharma. It will evaluate whether any compounds migrate from the packaging into the product itself under real-world storage conditions. The data from this study will feed into the Chemistry, Manufacturing and Controls (CMC) section of LTR Pharma’s planned New Drug Application.
LTR Pharma Executive Chairman, Mr Lee Rodne, said: "The completion of our extractables study and commencement of the leachables phase keep our regulatory program on schedule. Working with Aptar Pharma provides us with their established expertise in nasal spray device development and FDA submissions. These studies are necessary steps in our development pathway, and we look forward to progressing through each regulatory milestone."
This progress aligns with the Company’s comprehensive regulatory strategy, outlined in its FDA pre-IND meeting, and also follows the path to submitting a 505(b)(2) application for its flagship SPONTAN® product.
About us:
About LTR Pharma Limited (ASX:LTP)
LTR Pharma is an emerging pharmaceutical company committed to developing and commercialising innovative therapies that address significant unmet medical needs. The Company is leveraging its proprietary intranasal drug delivery platform to enable rapid, non-invasive treatment options across multiple therapeutic areas.
LTR’s lead products, SPONTAN® and ROXUS®, are fast-acting intranasal sprays for the treatment of erectile dysfunction, enabling onset of action in 10 minutes or less. Building on this proven technology, the Company is now advancing OROFLOW®, a novel intranasal spray under development for the treatment of Oesophageal Motility Disorders (OMD) – a debilitating group of conditions affecting swallowing function.
Through strategic partnerships, LTR Pharma is expanding its pipeline and global footprint to deliver differentiated, patient-centric treatments that enhance quality of life.
Contact details:
Jane Morgan
Jane Morgan Management
Investor & Media Relations
[email protected]
