Medical Developments International (ASX: MVP) should trade...

Medical Developments International (ASX: MVP) should trade higher after the Medicine and Healthcare products Regulatory Agency issued the Final Assessment Report with the support of France, Belgium and Ireland authorities for its Penthrox pain relief product.

All outstanding issues pursuant to the Decentralised Procedure have been successfully resolved and Penthrox is approvable.

Penthrox is a fast onset, non-opioid analgesic indicated for pain relief by self-administration in patients with trauma and those requiring analgesia for surgical procedures.

Penthrox has been used safely and effectively for more than 30 years in Australia with excess of 5 million units sold.

There is growing interest in Penthrox being used in patients undergoing investigatory procedures, as well as operational procedures such as colonoscopy.

MVP now moves into the National Phase which is an administrative process whereby each of the countries approve the translation of the labelling and product information, and registers Penthrox as being available for sale in their national records.

The National Phase should take 30 days and thereafter Marketing Authorisation will be issued and Penthrox will be available for sale in these markets.

MVP has Galen Limited as its Licensing and Distribution Partner in the UK and Ireland and expects sales to commence within the next three months.

Upon approval MVP will receive a second milestone payment of circa $850,000, with additional sales based milestone payments to follow.

The initial approval of Penthrox for use in the United Kingdom, France, Belgium and Ireland is a significant event for MVP.

In these four countries there are more than 50 million Accident & Emergency hospital attendances each year.

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