Medical Developments close to Penthrox approval in UK

Medical Developments International (ASX:MVP) expects to receive formal approval to sell its Penthrox inhaled analgesic product in the UK and three other markets within 90 days.

The company has received positive feedback from the UK’s Medicine and Healthcare products Regulatory Agency (MHRA) regarding its Penthrox application.

The MHRA has determined that based on a review of clinical data, it considers that the application for Penthrox in the treatment of pain is approvable so long as some outstanding points are satisfactorily addressed.

Medical Developments International has stated that the outstanding points - including some labelling, training and clinical matters - are already being addressed.

If the matters are resolved, the company should be free to sell Penthrox in the UK and Ireland in about April or May this year. Approval would also pave the way for the sale of the product in France and Belgium as part of the EU’s Decentralised Procedure.

“The approval of Penthrox for use in the United Kingdom, France, Belgium and Ireland will be a company-making achievement for us,” Medical Developments International CEO John Sharman commented.

“It opens up these European markets to Penthrox for the first time and, more importantly, pursuant to the ‘Mutual Recognition’ process for further regulatory approvals for other countries within the European Union.”

Medical Developments International separately announced that it has appointed chartered accountant Philip Powell as non-executive director.

Powell has been involved in investment banking since 1996, having held roles including executive director at corporate finance advisory firm Kidder Williams and several senior finance roles at OAMPS Limited.

Medical Developments International (ASX:MVP) shares were trading unchanged at $1.60 as of around 12.30 pm on Wednesday