Penthrox methoxyflurane inhaler maker Medical Developments International said that it recently met with the FDA regarding the agency’s August 2018 clinical hold letter on Penthrox, and the company now has a path forward to resolve the issues. Penthrox is already approved in Australia, Canada, and the majority of Europe.
According to MVP, the FDA has dropped a request for an animal study to predict idiosyncratic hepatoxicity. MVP had initially proposed excluding healthy volunteers from the study if they had previously experienced hepatoxicity from methyoxyflurane or halothane, and the agency had asked for changes to the exclusion criteria. The company will perform a study in animals that “replicates the human dosing regimen” for the inhaler, which is expected to take approximately 6 months.
MVP CEO John Sharman commented, “We had a good discussion with the FDA and we are clear as to what is required. Of particular importance is the willingness of the FDA to consider the recent safety data generated in Europe, and in particular the United Kingdom’s Post Authorisation Safety Study. We are confident this data will prove the safety of Penthrox to the satisfaction of the FDA and expect to submit our full response to the IND clinical hold during early 2020.”
Read the MVP press release.
