How LTR Pharma’s Safety Study Completion Advances SPONTAN’s FDA Journey
LTR Pharma has successfully completed the extractables study for its intranasal erectile dysfunction spray SPONTAN, confirming safety compliance and initiating the next phase of leachables testing to support FDA approval.
- Extractables study for SPONTAN completed with all compounds below ICH safety thresholds
- Leachables study commenced under real-world storage conditions
- Studies critical for FDA 505(b)(2) regulatory submission
- Partnership with Aptar Pharma supports device and regulatory expertise
- Ongoing clinical and manufacturing milestones planned
Regulatory Milestone Achieved
LTR Pharma Limited (ASX, LTP) has reached a significant regulatory milestone in the development of SPONTAN®, its intranasal spray for erectile dysfunction. The company announced the completion of the extractables study, a key safety evaluation that assesses potential chemical compounds released from the product’s packaging components. Conducted in collaboration with Aptar Pharma, the study confirmed that all detected compounds fall below the stringent safety thresholds set by the International Council for Harmonisation (ICH), standards recognised globally by the FDA and other regulatory bodies.
Next Phase, Leachables Study Underway
Following this success, LTR Pharma has initiated the leachables study, which examines the migration of compounds from the packaging into the drug product under real-world storage conditions. This phase is critical to ensure that the product remains safe and effective throughout its shelf life. Aptar Pharma continues to oversee this study, which is expected to run for at least 24 months to meet FDA shelf-life requirements. Importantly, the FDA allows submission of the New Drug Application once sufficient robust data is available, even as the study continues post-approval.
Strategic Regulatory Pathway
The extractables and leachables studies form an essential part of the Chemistry, Manufacturing, and Controls (CMC) section of LTR Pharma’s planned FDA 505(b)(2) submission. This regulatory pathway leverages existing data from approved drugs to streamline approval for new formulations or delivery methods. LTR Pharma’s Executive Chairman, Lee Rodne, emphasised the importance of these studies, highlighting the value of Aptar Pharma’s expertise in nasal spray device development and regulatory submissions.
Broader Pipeline and Market Strategy
Beyond SPONTAN, LTR Pharma is advancing other intranasal therapies, including ROXUS®, another erectile dysfunction treatment, and OROFLOW®, targeting oesophageal motility disorders. The company is simultaneously building commercial foundations through early access programs in Australia and preparing for a US market entry. The completion of these extractables and leachables studies not only advances SPONTAN’s regulatory progress but also strengthens LTR Pharma’s position in the competitive pharmaceutical landscape.
Looking Ahead
With the extractables study behind them and the leachables phase underway, LTR Pharma is on track to meet its regulatory milestones. The company’s methodical approach to safety and compliance underscores its commitment to delivering innovative, patient-centric therapies. Investors and industry watchers will be keenly observing the progress of the leachables study and subsequent FDA submission updates as LTR Pharma moves closer to commercialisation.
Bottom Line?
LTR Pharma’s steady regulatory progress with SPONTAN sets the stage for upcoming FDA submissions and market entry.
Questions in the middle?
- When will sufficient leachables data be available to support FDA submission?
- How might ongoing clinical and manufacturing milestones impact the regulatory timeline?
- What are the commercial launch plans for SPONTAN in the US following approval?
