QRxPharma moving closer to market with MoxDuo IR
Tuesday, 27 July, 2010
QRxPharma reported this week that it is making important progress towards gaining European and US regulatory approval for its dual-opioid pain treatment MoxDuo IR.
The company noted positive results of two European Scientific Advice Meetings held in May in Germany and the UK which has encouraged it to apply for initial European MAA ( Marketing Authorisation Application ) review in Germany next year, paving the way for wider EU approval. The European pain market is the second largest behind the US and is valued at around $US3.5 billion.
MoxDuo IR is currently near the end of Phase III trials in US after which the company intends to submit a NDA (new drug application).
QRxPharma CEO Dr John Holaday said that the feedback from Europe marks an important step in the company’s plans to launch MoxDuo globally by 2012.
The German Institute for Drugs and Medical Devices (BfArM) confirmed that the data package from the US studies was acceptable for MAA submission in Europe. It has also called for a Phase III study in bunionectonomy patients comparing the adverse event profile of MoxDuo IR to equi-analgesic doses of morphine and oxycodone. The study will also compare these treatments with MoxDuo IR in terms of key side effects including moderate-severe nausea, emesis or dizziness.
A Phase III study conducted by QRxPharma in April showed that MoxDuo IR had superior analgesic effects compared with morphine and oxycodone and with less side effects.
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