LTR Pharma (ASX:LTP) has announced extremely positive results from its SPONTAN® pivotal bioequivalence clinical study. Initial analysis has concluded that SPONTAN® achieves rapid absorption and faster onset of action compared to oral PDE5 inhibitors.
The results demonstrated that SPONTAN achieves rapid absorption and faster onset of action at a substantially lower dose, compared to traditional PDE5 oral tablets. By bypassing the digestive system, the intranasal delivery technology of SPONTAN results in a faster effect within as little as 9 minutes, compared to an average of 56.4 minutes in oral administered patients.
Importantly, SPONTAN also demonstrated an improved safety and tolerance profile, and the study showed better response consistency for the nasal spray patient cohort.
LTR Pharma Chairman, Lee Rodne said:
“The initial findings from our pivotal clinical study are truly exciting. SPONTAN® has the potential to make a significant impact on the global PDE5 inhibitor market, providing men with a more convenient and effective solution for erectile dysfunction (ED).”
Based on these promising results, LTR Pharma plans to expedite regulatory filings in the United States and Australia, seeking fast-track FDA approval and TGA approvals and subsequently seeking approvals in other key markets. This strategic move will enable the Company to bring SPONTAN to market promptly, meeting the high demand for innovative ED treatments globally.