LTR Pharma Limited has announced the successful completion of its pivotal clinical study for Spontan, an intranasal formulation of vardenafil for erectile dysfunction (ED).
The study demonstrated Spontan's rapid onset of action and enhanced bioavailability compared to traditional oral ED medications, positioning it as a potential disruptor in the global ED market.
Key findings include a 470% faster absorption rate, with Spontan reaching peak plasma concentration in 12 minutes, compared to 56 minutes for oral tablets.
Despite using half the dose, Spontan showed 111.8% dose-normalised bioavailability and a 155.6% higher peak concentration, suggesting comparable efficacy with a lower dose.
The formulation was well-tolerated, with no serious adverse events reported.
Chief Medical Officer Prof Geoffrey Strange noted the potential of Spontan to address unmet needs in ED treatment, highlighting its speed of absorption and favourable safety profile.
"These results offer patients a more spontaneous and convenient therapeutic option," he said.
The study, involving 18 healthy adult males, compared Spontan to oral tablets over 24 hours, confirming its faster onset and comparable bioavailability.
Chairman Lee Rodne added, "these results position LTR Pharma to advance commercialisation efforts, regulatory discussions, and strategic partnerships, reinforcing our commitment to delivering innovative solutions for patients". JG
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