- Australian company Medical Development International is one step closer to launching Penthrox in Russia
- The non-opioid pain killer has been used in Australia for over 40 years and it has been approved in over 40 countries
- In September a Marketing Authorisation Application for Penthrox was submitted to the Eurasian Economic Union
- The Russian Ministry of Health has now accepted the application in a process that is expected to take up to 15 months before approval for sale
- The review and approval process in Belarus, Kazakhstan, Armenia and Kyrgyzstan, however, will take up to two years
- Shares in Medical Development International rose 1.55 per cent higher to be worth $7.20 each at market close.
Australian company Medical Development International (MVP) is one step closer to launching Penthrox in Russia.
A Marketing Authorisation Application (MAA) for Penthrox was submitted to the Eurasian Economic Union in September.
Following a two-months validation period, the application has been approved for review by the Russian Ministry of Health.
Now, the ministry will review the ‘Clinical, Safety and Efficacy’ data which was also used to support the MAA in other countries.
To date, Penthrox has been approved in over 40 countries and in Australia, the non-opioid analgesic has been in use for over 40 years.
The review and final approval for sale in Russia will take up to 15 months.
Medical Development International CEO John Sharman says it been a long process to get to this milestone.
“We have been working on our MAA in Russia for several years and its acceptance for review by the Ministry of Health is a significant achievement and pointer to our future in Europe,” he said.
The MAA acceptance will also trigger a milestone payment to Medical Development International from Russian-partner and pharmaceutical supplier Lancet.
The application will also be assessed in other member countries of the Eurasian Economic Union. Belarus, Kazakhstan, Armenia and Kyrgyzstan will take up to two years to complete the review and final approval.
Shares in Medical Development rose 1.55 per cent higher to be worth $7.20 each at market close.