Medical Developments International (MVP), which announced in July 2018 that it was expecting a clinical hold letter from the FDA regarding its US clinical program for its Penthrox methoxyflurane inhaler, said that it has now received the letter from the FDA and believes that the company can satisfy the FDA’s requirements.
According to MVP, the FDA is requiring the company to change the exclusion criteria for the Phase 1 study. MVP had proposed using healthy volunteers excluding those who had experienced hepatoxicity from either methoxyflurane or halothane previously. The agency wants the company “to identify an appropriate patient population . . . for whom the risk/benefit of Penthrox would be reasonable,” MVP said, along with providing more information regarding idiosyncratic hepatoxicity and justification of the risk of its occurrence, which MVP says is rare.
Some of the other information requested by the agency pertains to questions about the “whistle” delivery device, including the instructions for use, the amount of methoxyflurane captured in an activated carbon chamber that absorbs exhaled drug, and performance of the inhaler’s valve system.
MVP CEO John Sharman commented, “We are currently consulting with ourscientific team, USA and EU advisors on the development program needed to satisfy the FDA’s requirements. We will report back to the market as to the impact on costs and timeframes in due course.”
Penthrox is already approved in Australia, Canada, and most of Europe.
Read the MVP press release.
