- Full commercial launch expected in the coming weeks of March
- An estimated 10 million people are living worldwide with pain from bone metastases
NEW YORK, March 12, 2020 - Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotech company, announced today the first patient has been dosed in a commercial setting with its U.S. FDA approved non-opioid drug Strontium89 (Strontium Chloride Sr-89 Injection, USP) for patients with pain from metastatic bone cancer.
The Company completed its initial commercial production run and shipment in February and is pleased to have dosed the first of what it expects to be thousands of patients in the coming years. Due to the opioid crisis, clinicians and patients are looking for pain management alternatives. Strontium89, which can be administered every 3 months, was shown in numerous clinical trials to relieve pain in over 70% of patients who received the treatment.
“With an estimated 10 million people living with bone metastases, we expect that even a small penetration in this market will have dramatic effects on QBioMed’s future. We believe this drug has a very important role to play as clinicians move toward proven non-opioid therapeutics for pain palliation for patients with painful bone metastases,” stated Q BioMed CEO Denis Corin.
Q BioMed plans to launch the drug in global markets, including Europe, in late 2020.
To learn more please visit www.Strontium89.com.
INDICATIONS AND IMPORTANT SAFETY INFORMATION:
INDICATIONS AND USAGE
Strontium Chloride Sr-89 Injection, USP is indicated for the relief of bone pain in patients with painful skeletal metastases. The presence of bone metastases should be confirmed prior to therapy.
Use of Strontium-89 Chloride Injection in patients with evidence of seriously compromised bone marrow from previous therapy or disease infiltration is not recommended unless the potential benefit of the treatment outweighs its risks. Bone marrow toxicity is to be expected following the administration of Strontium-89 Chloride Injection, particularly white blood cells and platelets. The extent of toxicity is variable. It is recommended that the patient’s peripheral blood cell counts be monitored at least once every other week. Typically, platelets will be depressed by about 30% compared to pre-administration levels. The nadir of platelet depression in most patients is found between 12 and 16 weeks following administration of Strontium-89 Chloride Injection. White blood cells are usually depressed to a varying extent compared to pre-administration levels. Thereafter, recovery occurs slowly, typically reaching pre-administration levels six months after treatment unless the patient’s disease or additional therapy intervenes. In considering repeat administration of Strontium-89 Chloride Injection, the patient’s hematologic response to the initial dose, current platelet level and other evidence of marrow depletion should be carefully evaluated. Verification of dose and patient identification is necessary prior to administration because Strontium-89 Chloride Injection delivers a relatively high dose of radioactivity.
Strontium-89 Chloride Injection may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.
Strontium-89 Chloride Injection is not indicated for use in patients with cancer not involving bone. Strontium-89 Chloride Injection should be used with caution in patients with platelet counts below 60,000 and white cell counts below 2,400.
Radiopharmaceuticals should only be used by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
Strontium-89 Chloride Injection, like other radioactive drugs, must be handled with care and appropriate safety measures taken to minimize radiation to clinical personnel.
In view of the delayed onset of pain relief, typically 7 to 20 days post injection, administration of Strontium-89 Chloride Injection to patients with very short life expectancy is not recommended.
A calcium-like flushing sensation has been observed in patients following a rapid (less than 30 second injection) administration.
Special precautions, such as urinary catheterization, should be taken following administration to patients who are incontinent to minimize the risk of radioactive contamination of clothing, bed linens and the patient’s environment.
Strontium-89 Chloride Injection is excreted primarily by the kidneys. In patients with renal dysfunction, the possible risks of administering Strontium-89 Chloride Injection should be weighed against the possible benefits.
Teratogenic effects. Pregnancy Category D. See Warnings section.
Because Strontium-89 Chloride Injection acts as a calcium analog, secretion of Strontium-89 Chloride Injection into human milk is likely. It is recommended that nursing be discontinued by mothers about to receive intravenous Strontium-89 Chloride Injection. It is not known whether this drug is excreted in human milk.
Safety and effectiveness in children below the age of 18 years have not been established.
A single case of fatal septicemia following leukopenia was reported during clinical trials. Most severe reactions of marrow toxicity can be managed by conventional means.
A small number of patients have reported a transient increase in bone pain at 36 to 72 hours after injection. This is usually mild and self-limiting, and controllable with analgesics. A single patient reported chills and fever 12 hours after injection without long-term sequelae.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.FDA.gov/medwatch or call (800) FDA-1088.
Please see full Prescribing Information for Strontium-89 Chloride Injection.
About Q BioMed Inc.
Q BioMed Inc. is a biotech acceleration and commercial stage company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets the strategic resources, developmental support, and expansion capital needed to ensure they meet their developmental potential, enabling them to provide products to patients in need.
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