LTR Pharma’s SPONTAN spray has met the requirements for earning an FDA clinical trial.
Aussie men’s health company LTR Pharma will take its erectile dysfunction nasal spray treatment, SPONTAN, to the FDA after successfully completing pivotal stability and quality control milestones.
By testing the chemical stability of SPONTAN over three specified periods, including assessing packaging integrity and confirming purity of the active ingredients, LTR has met FDA requirements to be considered for a pivotal study.
Patient recruitment for SPONTAN’s bioequivalence study will start this month. It is a randomised, open label, single dose, two treatment crossover study that looks at how the body processes active ingredient vardenafil after giving it to 18 healthy adult men in the form of the SPONTAN nasal spray and in tablet form.
“We are optimistic about the potential impact of SPONTAN in the market and look forward to sharing our progress as we move closer to initiating the clinical trial,” said LTR Pharma chairman Leo Rodne.
