LTR Pharma has announced the initiation of a bioequivalence study of its Spontan vardenafil nasal spray, which the company is developing for the treatment of erectile dysfunction. According to LTR, the study will compare a single dose of Spontan, 5 mg (2 sprays of 2.5 mg each) to 10 mg tablets of vardenafil in healthy adult males. The company says that it intends to use the study data to support NDA submissions to the TGA and the FDA.
LTR Pharma Chairman Lee Rodne commented, “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.”
Read the LTR Pharma press release.
