Brisbane-based LTR Pharma has secured ethics approval for a bio-equivalence clinical study of its intranasal spray for erectile dysfunction, SPONTAN.
SPONTAN is based on an intranasal delivery technology that bypasses the digestive system and is designed to overcome the issues of other erectile dysfunction oral tablets by having a significantly faster onset of action within five to 15 minutes.
LTR Pharma executive chairman and CEO Lee Rodne said SPONTAN has the potential to revolutionise the way men manage erectile dysfunction.
“SPONTAN is a truly innovative, fast-acting treatment, which is on track to disrupt the established blockbuster oral PDE5 market. Current oral tablets such as Viagra can take up to one hour to take effect, and many men are dissatisfied with the results as they don’t always work or in the time desired,” said Mr Rodne.
“We are thrilled to have received ethics approval for this pivotal clinical study – a crucial step in clinical validation and our expedited regulatory journey, as we prepare to market this product around the world,” said Mr Rodne.
LTR Pharma is pursuing the expedited FDA 505(b)(2) regulatory process. The company said it has received approval from the Bellberry Human Research Ethics Committee (‘HREC’) for a bioequivalence clinical trial comparing its proprietary multi-use Nasal Spray SPONTAN with the FDA-approved drug Levitra (vardenafil).
The trial will compare the pharmacokinetics, safety and tolerability of vardenafil after administering LTR’s SPONTAN and vardenafil tablets in healthy male adults. Patient recruitment is expected second half of this year, with trial sites set to be opened in Sydney.
LTR Pharma collaborated with a founding researcher from the US, Professor Moses Chow, who developed a proprietary compound (SDS089 now called SPONTAN) as a nasal spray to treat patients with erectile dysfunction. LTR Pharma has in-licensed on a global exclusive basis all rights to develop, manufacture, commercialise and sell the compound as a nasal spray product.