Medical Developments International updates on Penthrox in the US

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Medical Developments International (ASX:MVP) says it has received correspondence from the FDA in relation to its Investigative New Drug application to have Penthrox approved for sale in the US.

According to the company, the FDA requires MVP to identify an appropriate patient population for its suggested Phase I Study for whom the risk and benefit of Penthrox would be reasonable.

The says it has suggested the appropriate population would be healthy volunteers excluding patients who had previously developed hepatoxicity after administration of either methoxyflurane or halothane. However, it said the FDA has advised it does not consider this population exclusion to be adequate.

MVP said in it believes it can identify an appropriate patient population and satisfy the FDA’s concern.

"The FDA requested additional information and justification for the rare occurrence of idiosyncratic hepatoxicity," said the company. "MVP believes it will be able to illustrate satisfactorily to the FDA the rare occurrence of idiosyncratic hepatoxicity and the acceptability of this risk in terms of the overall benefit of Penthrox compared with dangerous opioid alternatives."

It continued, "The FDA has asked for clarification around a chloroform impurity which is a process element in the manufacturing of methoxyflurane. MVP’s new manufacturing technology meets the globally accepted standard for chloroform and MVP believe it can comply with the FDA’s acceptable limits.

"The FDA raised questions about the 'Instructions For Use' material for the Penthrox device (whistle). MVP believes it can satisfy the FDA in this regard.

"The FDA requires additional information about the variability of concentrations of the administration of methoxyflurane from closing the dilutor hole in the whistle. MVP believes it can supply the additional information the FDA requires.

"The FDA questioned the amount/volume of methoxyflurane captured in the activated carbon device (the AC Chamber device which fits on top of the whistle), which is used to scavenge the smell and the exhaled methoxyflurane from a patient’s breath. The FDA has asked for additional testing to demonstrate the absorption capacity of the AC Chamber. MVP believes it can satisfy this request.

"The FDA queried the performance of the inbuilt valve system within the whistle and asked a number of questions around the performance characteristics of these valves. MVP believes it can satisfactorily respond to the FDA’s questions."

The company added the FDA has advised of other issues that do not form part of its 'Clinical Hold” Statement'.

The issues to be addressed include: The inadvertent exposure of methoxyflurane to healthcare professionals; minor amendments to the labelling suggested in our application; additional analytical tests to be used for both release and stability control testing; amendments to acceptance criteria of impurities in the finished product of methoxyflurane; and, additional biocompatibility testing for the whistle itself.

"MVP believes it can satisfactorily respond to these issues," it said.

“We are currently consulting with our scientific 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,” said MVP CEO Mr John Sharman.