SPONTAN Phase II data show rapid onset, support FDA pathway
Filed with ASX · · 6 pages · English
Summary by 6ix AI
LTR Pharma Limited reports interim Phase II pharmacokinetic data for SPONTAN, demonstrating rapid onset and a favorable safety profile across adult and geriatric populations. The data support the company's planned FDA regulatory pathway, with final results expected in the third quarter of the following year. Key findings include a median time to peak concentration significantly shorter than that of oral alternatives, with no serious adverse events reported. The study was designed in accordance with FDA Pre-IND guidance and aims to address unmet medical needs in erectile dysfunction treatment.
Written by 6ix AI from the company’s filing. How 6ix writes summaries
In the deck
Story so far
Earlier from LTR Pharma
- SPONTAN Phase II Clinical Study Completes Recruitment
- Appendix 4D and Half Yearly Report
- SPONTAN Shows Positive Outcomes in Younger Men with ED
- Quarterly Activities/Appendix 4C Cash Flow Report
- First Patients Dosed in SPONTAN Phase II Clinical Study
Later from LTR Pharma
- SPONTAN® Phase II interim data demonstrates rapid onset and pharmacokinetic profile addressing FDA Pre-IND requirements across adult and ≥65 populations
- LTR Secures First U.S. Commercial Agreement for ROXUS
- LTR Secures Exclusive U.S. Pharmacy Partner for ROXUS
- Response to ASX Aware Letter
- LTR Executes Definitive U.S. Commercial Agreement with Shed
Follow LTR Pharma into a list and get an email when it puts out news.
Follow LTR Pharma