LTR Pharma (ASX:LTP) said it completed a successful pre-investigational new drug meeting with the US Food and Drug Administration, providing a defined path to approval for its SPONTAN intranasal spray, according to a Wednesday Australian bourse filing.
The meeting resulted in an alignment on a streamlined clinical development path, including one pivotal safety and efficacy trial and a multi-dose pharmacokinetic study.
The FDA broadly endorsed LTR's non-clinical toxicology and chemistry, manufacturing and controls development plans. It plans to investigate the ability to use additional clinical trial data for the US with other regulatory submissions in key global markets.
It also plans to introduce its vardenafil-based nasal spray Roxus into the US market. Roxus is being developed together with an Australian pharmaceutical partner in Australia and testing is being conducted to establish stability and shelf-life.
Its shares fell 9% as of market close on Wednesday.
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