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EMA Gives Positive Opinion Regarding Tetra Bio-Pharma Inc.’s (OTCMKTS: TBPMF)QIXFEEL Drug In CRPS Treatment



Tetra Bio-Pharma Inc. (OTCMKTS: TBPMF) has received a positive opinion from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) regarding its Orphan Drug Designation application for the experimental drug QIXLEEF as a possible Complex Regional pain Syndrome (CRPS) treatment. CRPS is a chronic neuropathic pain condition.

COMP issues positive opinion ion QIXLEEF

The company’s CEO and Chief Regulatory Officer, Guy Chamberland, said, “The positive opinion issued by the COMP is excellent news as Tetra continues to execute its regulatory strategy in Europe. An ODD brings several unique advantages, from a cost reduction in drug development, to an accelerated review process and market exclusivity for 10 years. Such strategy is cost and time effective and allows the company to easily gain market shares in a competitive free environment. If granted, this would represent QIXLEEF’s second ODD as a potential treatment for CRPS, in addition to the ODD granted by the U.S. FDA in March 2018. We firmly believe that QIXLEEF will be a safe and effective medicine for pain management and an alternative to opioids.”

QIXLEEF has the potential of being a CRPS treatment 

The COMP’s favorable conclusion will be forwarded to the European Commission, which is likely to grant orphan status within 30 days. The regulatory body found that QIXLEEF met the requirements for orphan medicinal product designation and recommended that it be granted based on a majority of 30 votes out of 31 cast.

Also, the EMA COMP established that QIXLEEF is eligible as an orphan drug for treatment CRPS because the medicinal product is intended to treat a chronic debilitating condition. Equally, this rare condition’s estimated prevalence in the EU is 4.4 in 10,000 people, with available data from published literature showing peripheral neuropathic pain improvement in individuals treated with cannabinoid-based medications.

Since QIXLEEF targets an orphan condition, clinical studies will be carried with a considerably smaller patient number, and it qualifies for conditional approval in EU member states.

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