SPONTAN® Sets New Standard: 470% Faster Absorption In Latest Pivotal Study

LTR Pharma Limited is excited to share that it has successfully completed the data evaluation phase of the SPONTAN® pivotal clinical study. This study assessed the pharmacokinetics and safety of SPONTAN, a novel intranasal vardenafil formulation aimed at treating erectile dysfunction (ED). For further details, please refer to the ASX Announcement dated June 7, 2024, which outlines the initial results of the study.

Notable findings from this randomized, open-label, cross-over study reveal that SPONTAN Nasal Spray (5 mg vardenafil) produced a significantly quicker time to reach maximum plasma concentration (Tmax) compared to the oral tablet (10 mg vardenafil). Specifically, SPONTAN demonstrated a mean Tmax of 12 minutes, while the oral tablet reached Tmax at 56 minutes.

This quick onset provides patients with increased spontaneity and convenience over traditional oral erectile dysfunction (ED) medications. Notably, SPONTAN exhibited similar bioavailability to the oral tablet when normalized for dose. Even at a lower dose of 5 mg, the nasal spray achieved a dose-normalized bioavailability of 111.8% in comparison to the oral tablet.

Furthermore, the peak plasma concentration (Cmax) of SPONTAN was also comparable when normalized for dose, reaching 155.6% of the Cmax of the oral tablet. The half-life (t½) of vardenafil was nearly identical for both forms, with SPONTAN showing an average half-life of 4.15 hours, while the oral tablet had a half-life of 4.23 hours. SPONTAN was generally well-tolerated, with no serious adverse events (SAEs) reported. All treatment-emergent adverse events (TEAEs) were mild to moderate and transient, supporting that the overall safety profile of SPONTAN aligns with the established safety profile of vardenafil.

LTR Pharma Chief Medical Officer, Professor Geoffrey Strange, said in a statement, “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. 

He further added, “The speed of absorption, coupled with the excellent bioavailability and safety profile, offers patients a more spontaneous and convenient therapeutic option. These data have been supported by positive anecdotal efficacy feedback from patients to prescribers of SPONTAN under the Special Access Scheme. Together, these data, support our belief that SPONTAN® may represent a meaningful advancement in ED management.”