LTR Pharma has completed extractables studies for SPONTAN®, its intranasal spray for erectile dysfunction, with co-development partner Aptar Pharma. All identified compounds were confirmed below ICH safety thresholds.
This milestone represents a required step in the Company’s FDA 505(b)(2) regulatory submission pathway. The FDA requires Extractables and Leachables (E&L) studies for all pharmaceutical products to ensure packaging materials do not compromise product safety or efficacy.
With extractables complete, the leachables study has now commenced under real-world storage conditions. The leachables study will run for at least 24 months to support shelf-life requirements, with both studies forming part of the Chemistry, Manufacturing and Controls (CMC) section of the Company’s planned New Drug Application.
The Company can submit its application once sufficient robust data is available, with study completion continuing post-approval as standard.
LTR Pharma 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.”