LTR Pharma (ASX:LTP) has announced the successful completion of the pivotal clinical study for Spontan, the company’s novel intranasal formulation of vardenafil for the treatment of erectile dysfunction.
The company said the study’s pharmacokinetic and safety data demonstrate Spontan's rapid onset of action and enhanced bioavailability compared to traditional oral erectile dysfunction (ED) medications. It said Spontan achieved a time to maximum plasma concentration of 12 minutes, compared to 56 minutes for oral vardenafil tablets, representing a 470 per cent faster absorption rate.
LTR Pharma chief medical officer Professor Geoffrey Strange said, “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 involved 18 healthy adult males and used a cross-over design to compare Spontan Nasal Spray with an oral tablet.
LTR Pharma said the positive results will support its engagement with key regulatory bodies, including the TGA and US FDA.
LTR Pharma chair Lee Rodne added, “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. This success reinforces our commitment to delivering innovative solutions that can significantly improve patients' lives while creating value for our shareholders.”