Q BioMed and Bio-Nucleonics, licensor of Strontium 89 Chloride, announce submission of a regulatory filing to the FDA for the approval of a new manufacturing facility. Upon approval by the FDA, the facility will be permitted to manufacture Strontium Chloride Sr89 Injection USP (Strontium-89) in accordance with cGMP.
Strontium-89 is a non-opioid injectable radiopharmaceutical to relieve cancer bone pain in patients with painful skeletal metastases. In the body, strontium acts similar to calcium, selectively localizing in bone and is preferentially taken up in osteoblastic lesions. The unabsorbed isotope clears rapidly from the blood and is excreted in the urine the first 2 to 3 days following injection. Uptake of Strontium-89 occurs preferentially in sites of active osteogenesis; thus bone tumors and areas of metastatic involvement (blastic lesions) can accumulate significantly greater concentrations of Strontium-89 than surrounding normal bone.
Strontium-89 is a pure beta emitter, and selectively irradiates sites of primary and metastatic bone involvement with minimal irradiation of soft tissues distant from bone lesions. The presence of bone metastases should be confirmed prior to therapy. When blastic osseous metastases are present, significantly enhanced localization of the radiopharmaceutical will occur with corresponding higher doses to the metastases compared with normal bones and other organs. Although responses can vary, pain relief typically begins 7 to 20 days after injection and lasts for four months or more.