The European Medicines Agency (EMA) has given a positive opinion for Orphan Drug Designation (ODD) for Tetra Bio-Pharma’s QIXLEEF.
Cannabinoid-derived drug discovery company Tetra Bio-Pharma has received a positive opinion from the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) on its application for ODD for its investigational medicine QIXLEEF as a potential treatment for Complex Regional Pain Syndrome (CRPS), a chronic neuropathic pain condition.
The medicine is a botanical inhaled drug product with a fixed ratio of THC and CBD that provides fast-acting relief from pain, which the company says offers patients a viable, safer, and non-opioid option for pain management.
Tetra CEO and CRO, Dr Guy Chamberland, commented: “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 US FDA in March 2018.
“We firmly believe that QIXLEEF will be a safe and effective medicine for pain management and an alternative to opioids.”
The positive opinion issued by the COMP will be sent to the European Commission, which is expected to grant the orphan designation within 30 days.
As the medicine will be intended to treat an orphan condition, clinical studies will be preformed with a significantly smaller number of patients and could be entitled to conditional approval through a decentralised procedure resulting in a single decision from the European Commission, valid in all EU Member States, which would shorten the time to market approval.