LTR Pharma completes study milestone for SPONTAN ED treatment

• LTR Pharma & co-development partner Aptar Pharma complete extractables study on SPONTAN
• All identified compounds below ICH safety thresholds for nasal spray-mist erectile dysfunction treatment 
• Leachables study initiated to support FDA regulatory submission under real-world storage conditions

Special Report: LTR Pharma has completed a key extractables study for its SPONTAN intranasal spray for erectile dysfunction and kicked off a leachables study as part of a regulatory development program.

LTR Pharma (ASX:LTP) said the extractables study, conducted under the supervision of co-development partner Aptar Pharma, evaluated the bottle and pump components of SPONTAN’s container closure system.

The study confirmed that all detected compounds were below ICH safety thresholds – the internationally recognised standards adopted by the US Food and Drug Administration (FDA) and regulatory authorities worldwide for pharmaceutical impurities.

LTR Pharma said the identified compounds would be monitored in the ongoing leachables study.

FDA requires extractables and leachables (E&L) studies for all pharmaceutical products to ensure packaging materials do not compromise product safety or efficacy.

For nasal spray products, these studies must meet specific regulatory thresholds due to direct tissue exposure.

Leachables study now underway

The leachables study has started under Aptar Pharma’s management, evaluating the potential migration of the compounds from packaging into SPONTAN under real-world storage conditions.

LTR Pharma said SPONTAN used industry-standard bottle and pump components as used in multiple FDA-approved nasal spray products.

The study will run for at least 24 months to support shelf-life requirements. Consistent with FDA practice for nasal sprays, the company can submit its application once sufficient robust data is available, with study completion continuing post-approval as standard.

E&L studies form part of LTR Pharma’s comprehensive regulatory strategy following its FDA pre-IND meeting, where the FDA confirmed the proposed development pathway.

The company said E&L data were required for the chemistry, manufacturing and controls (CMC) section of its planned new drug application (NDA).

With extractables results meeting regulatory requirements, the company progresses to the leachables phase for comprehensive regulatory submission data.

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Progress on SPONTAN and new US-targeted ROXUS

LTR Pharma continues to progress SPONTAN through established regulatory pathways while building commercial foundations through its Australian early access programs.

It is also progressing its new ED nasal spray called ROXUS, which offers a fast-track pathway to serve patients through the US personalised healthcare sector.

As with SPONTAN, ROXUS is based on the common active ingredient vardenafil. It will be delivered via the 503(a)-compounding pharmacy pathway, which exempts drugs from the usual approval, labelling and manufacturing requirements.

“The completion of our extractables study and commencement of the leachables phase keep our regulatory program on schedule,” LTR Pharma executive chairman Lee Rodne said.

“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 article was developed in collaboration with LTR Pharma, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.