The study will compare the bioavailability of the active ingredient Vardenafil when administered through SPONTAN nasal spray against oral Vardenafil tablets. Credit: New Africa / Shutterstock.

Australian pharmaceutical company LTR Pharma has begun recruiting subjects in a bioequivalence clinical study of SPONTAN, a quick-acting nasal spray designed to treat erectile dysfunction (ED).

The open-label, randomised crossover comparison study will enrol healthy adult male subjects, who will fast for the duration of the trial.

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It aims to compare the bioavailability of the active ingredient Vardenafil when administered through SPONTAN nasal spray against oral Vardenafil tablets, which are the current standard therapy, for four weeks.

The trial will take place in Sydney, Australia, in partnership with Southern Star Research and Scientia Clinical Research.

It will be conducted under the supervision of staff from Scientia Clinical Research, while Southern Star Research will oversee several aspects of the trial, including data management, monitoring, safety and pharmacokinetic assessments.

Findings from the study are expected to support regulatory submissions of the spray.

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Upon successful conclusion of the study and acquisition of the expected data, LTR Pharma plans to submit these findings as part of new drug applications to the US Food and Drug Administration (FDA) and Australia’s Therapeutic Goods Administration (TGA) for regulatory approvals.

The global ED market is projected to be worth $5.94bn by 2028, with more than 60% of males in Australia suffering from ED after the age of 45.

LTR Pharma chairman Lee Rodne said: “This study will form a critical piece of the data package we plan to submit to the FDA and TGA – supporting our plans for expedited regulatory approval for SPONTAN in key initial markets.

“We believe SPONTAN has the potential to disrupt the global blockbuster PDE5 market and we are excited to bring this innovation to men worldwide. I encourage all members of the public who meet the essential recruitment criteria to get involved.”