LTR Pharma (ASX:LTP) has announced that patient recruitment has commenced its pivotal bioequivalence clinical study for its innovative nasal spray treatment, SPONTAN.
The company said the study will assess the relative bioavailability of vardenafil following administration of SPONTAN nasal spray compared to oral delivery of vardenafil tablets.
LTR Pharma scientific and clinical Advisor, Professor Eric Chung, said, “On behalf of LTR Pharma, we are excited to welcome appropriately screened and suitable participants to participate in the Study – and look forward to building a clear picture of data that helps to inform measured regulatory and clinical access pathways for novel treatments in the treatment of ED [erectile dysfunction].”
The company said current oral PDE5 tablets are gold-standard treatments but have a high discontinuation rate with consumers. SPONTAN is designed to overcome this issue and to be a fast-acting-on-demand treatment for ED.
LTR Pharma, in partnership with its appointed clinical research facility, Scientia Clinical Research, is now welcoming healthy adult males to volunteer their time to be part of the Study.
LTR Pharma Chairman Lee Rodne added, “Commencing recruitment for our upcoming bioequivalence clinical study for our lead product, SPONTAN, is a significant achievement for our Company and in keeping with the clearly mandated clinical and commercial milestones that we communicated during our recent IPO campaign. 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.”