LTR Pharma (ASX:LTP) has announced that it has achieved its latest regulatory milestone for SPONTAN with the successful completion of extractables testing and the launch of its leachables studies.
LTR is developing the novel intranasal treatment, SPONTAN, for erectile dysfunction. The company stated that an extractables study was completed in collaboration with co-development partner Aptar Pharma, and all identified compounds were found to be below recognised safety thresholds. It said a leachables study is now underway to support FDA submission under real-world storage conditions.
The extractables study evaluated the bottle and pump components of the container closure system used to package and dispense SPONTAN’s solution. All the compounds detected were well below the safety thresholds defined by the International Council for Harmonisation (ICH) requirements, adopted by the US FDA, as well as several other regulators.
LTR said 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, also to be managed by Aptar Pharma, will evaluate whether any compounds migrate from the packaging into the product under real-world storage conditions.
Executive chairman 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."