Therapy Areas: Oncology
Q BioMed Inc reports US FDA filing for new facility to manufacture Strontium Chloride Sr89 Injection USP for metastatic cancer bone pain
21 August 2018 -

Biotechnology company Q BioMed Inc (OTCQB:QBIO) (OtherOTC:QBIO) said on Monday that it has submitted its supplemental regulatory filing with the US FDA for the approval of a new facility for the manufacture of Strontium Chloride Sr89 Injection USP for the relief of metastatic cancer bone pain.

The US FDA filing was initiated in partnership with BioNucleonics, licensor of Strontium 89 Chloride. The prior approval Supplement Filing under GDUFA Guidelines is final step in the approval process.

Following clearance by the US FDA, the company's new facility will be permitted to manufacture Strontium Chloride Sr89 Injection USP under cGMP. Strontium Chloride Sr89 Injection USP is an US FDA-approved non-opioid injectable radiopharmaceutical indicated to relieve cancer bone pain in patients with painful skeletal metastases.

According to the companies, Sr-89 is an effective, safe, non-narcotic analgesic alternative for the treatment of patients with painful skeletal metastases. Numerous studies have demonstrated significant palliative benefit in the management of painful bone metastases. Treatment with Sr89 has led to a significant improvement in quality of life for patients with metastatic bone disease associated with breast, lung and prostate cancer and has been demonstrated to reduce or eliminate the need for opioids.

Unlike many other therapies that demand that patients make repeated visits to hospitals for a course of treatment, Strontium Chloride Sr89 Injection is administered in a single visit and offers pain relief that can last for three months or more. Sr89 works by delivering radiation local to the bone metastases that results in pain relief by selectively targeting and accumulating in metastatic bone lesions with minimal risk of toxicity to surrounding normal tissue, concluded the company.

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