LTR Pharma’s (ASX:LTP) data evaluation phase of the SPONTAN ED treatment has delivered a 155.6% higher peak concentration despite using only half the dose.
The company has now completed the data evaluation phase of the SPONTAN pivotal clinical study evaluating the pharmacokinetics and safety profile of SPONTAN, its novel intranasal formulation of vardenafil for the treatment of erectile dysfunction (ED).
Key results from the randomised, open-label, cross-over study demonstrate that SPONTAN Nasal Spray (5 mg vardenafil) achieved a significantly faster time to maximum plasma concentration (Tmax) compared to the oral tablet (10 mg vardenafil).
SPONTAN achieved a mean Tmax of 12 minutes versus 56 minutes for the oral tablet. This rapid onset offers patients greater spontaneity and convenience compared to traditional oral ED medications.
Moreover, SPONTAN displayed a comparable bioavailability to the oral tablet on a dose-normalized basis. Despite the lower 5 mg dose, the nasal spray showed 111.8% dose-normalized bioavailability relative to the oral tablet.
Additionally, SPONTAN’s maximum plasma concentration (Cmax) was comparable on a dose-normalized basis, reaching 155.6% of the oral tablet’s Cmax. The half-life (t1⁄2) of vardenafil was similar for both formulations, with SPONTAN demonstrating a mean half-life of 4.15 hours, compared to 4.23 hours for the oral tablet.
SPONTAN was well-tolerated, with no serious adverse events (SAEs) reported. All treatment-emergent adverse events (TEAEs) were mild to moderate and transient. The overall safety profile of SPONTAN is consistent with the known safety profile of vardenafil.
“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,” LTR Pharma Chief Medical Officer, Professor Geoffrey Strange, said.
“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."
