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LTR Pharma (ASX:LTP) has reached a significant milestone in the development of SPONTAN®, its groundbreaking nasal spray treatment for erectile dysfunction (ED); and has now completed the recruitment and dosing for its pivotal clinical study.
SPONTAN® is a world-first, on-demand nasal spray designed to act fast, with effects felt within just 10 minutes. Unlike traditional oral tablets for ED, SPONTAN® bypasses the digestive system, offering a unique approach to addressing the condition, and the latest dosing and recruitment activity marks a crucial step towards potential market availability.
The clinical study, which compares SPONTAN® nasal spray to oral Vardenafil tablets, aims to evaluate the spray’s effectiveness and bioavailability. With recruitment and dosing now finished, data analysis has commenced, with results expected by mid-2024. These findings will be pivotal for pre-submission meetings with regulatory authorities such as the FDA and Australia’s early access scheme, and will facilitate potential initial sales.
“We are the first and only nasal spray coming to market for the treatment of Erectile Dysfunction and are extremely excited to bring this key innovation to men worldwide,” Chairman of LTR Pharma Lee Rodne said.
The clinical study, designed to meet regulatory requirements, involves healthy adult male subjects and aims to demonstrate the efficacy and safety of SPONTAN® compared to oral Vardenafil tablets.
With study results anticipated in mid-2024, LTR Pharma is optimistic about the future of SPONTAN® nasal spray and its potential to reshape the landscape of ED treatment and revolutionise the global market currently dominated by oral PDE5 inhibitors – like Viagra.
LTP was up 5 per cent on Friday’s close and was trading at 31.5 cents mid-morning.
