Q BioMed Inc. announced the FDA approval of its contract manufacturer IsoTherapeutics Group LLC (ITG). ITG is now cleared to manufacture the company’s FDA approved non-opioid cancer bone pain drug Strontium-89 Chloride USP.
 
The approval of the facility means that this oncologic pain drug will soon be available to patients in the U.S. and the rest of the world. Q BioMed is now the only FDA-approved source for this drug in the western world. The company is activating its planned commercial operations to support marketing, sales, and distribution in the U.S. and the rest of the world.
 
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.
 
QBioMed chief executive officer Denis Corin said, “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. 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.”