LTR Pharma Limited has announced the successful completion of a pivotal clinical study for SPONTAN, its novel intranasal formulation of vardenafil for erectile dysfunction treatment, demonstrating significantly faster absorption compared to traditional oral medications. The study's pharmacokinetic and safety data show SPONTAN achieved a time to maximum plasma concentration of 12 minutes, compared to 56 minutes for oral vardenafil tablets, representing a 470% faster absorption rate.
Clinical Study Results
The cross-over design study involved 18 healthy adult males comparing SPONTAN Nasal Spray with oral tablets. According to LTR Pharma Chief Medical Officer Professor Geoffrey Strange, "These results are highly encouraging from a clinical perspective. The rapid onset of action and pharmacokinetic profile of Spontan have the potential to address significant unmet needs in erectile dysfunction treatment. The speed of absorption, coupled with the excellent bioavailability and safety profile, offers patients a more spontaneous and convenient therapeutic option."
The study demonstrated enhanced bioavailability alongside the rapid onset of action, positioning SPONTAN as a potential disruptor in the erectile dysfunction treatment landscape.
Regulatory Progress
Concurrent with the clinical achievements, LTR Pharma has reached significant regulatory milestones through its partnership with Aptar Pharma. The company successfully completed extractables testing for SPONTAN's container closure system, with all identified compounds found to be below International Council for Harmonisation (ICH) safety thresholds adopted by the U.S. FDA.
The extractables study assessed the bottle and pump packaging system, supporting the safety profile of SPONTAN's packaging requirements. Following this success, leachables studies are now underway to evaluate compound migration from packaging into the product under real-world storage conditions. This data will contribute to the Chemistry, Manufacturing and Controls (CMC) section of LTR Pharma's planned New Drug Application.
Strategic Positioning
LTR Pharma Executive Chairman Lee Rodne emphasized the significance of these developments: "These study results mark a significant milestone for LTR Pharma. Spontan's pharmacokinetic profile and rapid onset of action demonstrate its potential to disrupt the global ED market. We are now well-positioned to accelerate our commercialisation strategy, including advancing regulatory discussions and exploring strategic partnerships."
The progress aligns with the company's comprehensive regulatory strategy outlined in its FDA pre-IND meeting and supports the path toward submitting a 505(b)(2) application for SPONTAN. Rodne noted that the completion of extractables testing and commencement of leachables studies keeps the regulatory program on schedule.
Technology Platform
SPONTAN represents LTR Pharma's proprietary intranasal drug delivery platform designed to enable rapid, non-invasive treatment options. The company's lead products, SPONTAN and ROXUS, are fast-acting intranasal sprays for erectile dysfunction treatment, enabling onset of action in 10 minutes or less. The platform technology is being expanded to OROFLOW, a novel intranasal spray under development for Oesophageal Motility Disorders.
The positive results will support LTR Pharma's engagement with key regulatory bodies, including the Therapeutic Goods Administration (TGA) and U.S. FDA, as the company advances toward commercialization of its innovative erectile dysfunction treatment.
