Q BioMed has announced the U.S. Food and Drug Association (FDA) approval of its contract manufacturer IsoTherapeutics Group. ITG is now cleared to manufacture the Company’s FDA approved non-opioid cancer bone pain drug Strontium-89 Chloride USP.
Strontium-89 is an FDA-approved non-opioid radiopharmaceutical indicated for the treatment of painful skeletal metastases caused by cancer. The product is administered intravenously once every three months as an alternative to opioid analgesics and plays a critical role in the treatment of metastatic bone pain. The product has a long history of providing well-documented and significant pain relief for patients suffering from the excruciating pain associated with primary cancers that have spread to the bone, including breast, prostate, lung and others. This is the ideal time to be launching Strontium-89 given the current concerns with the over-use of opioid drugs. In addition, as more therapies come to market for the treatment of primary cancers, more people are living longer with metastatic disease. It is estimated that approximately two million patients experience debilitating bone pain from metastatic disease. The opportunity to provide significant pain relief to this group is substantial.
“We have been anticipating this critical regulatory step for a long time, certainly longer than we hoped, but we are thrilled that we can now move forward with certainty,”
QBioMed CEO Denis Corin said.
“This is the start of a new chapter in the evolution of our company, and we are looking forward to serving the needs of thousands of patients suffering from metastatic bone pain, providing them the chance to minimize their pain and positively impact life with metastatic disease. With millions of potential patients around the world, this is a major market opportunity for our company. In addition, we are investigating and planning expansion trials to provide additional indications for the drug and entry into an even larger therapeutic market.”