Q Biomed (OTC:QBIO) and Bio-Nucleonics, the company licensing Q Biomed’s strontium chloride injection, have asked the FDA to approval a new manufacturing facility for the drug.
Strontium-89 is a non-opioid injectable designed to relieve pain in patients with metastatic bone disease.
The drug is given in a single injection and takes two weeks to reach its maximum potency within the body, according to CEO Denis Corin. There, it lasts for three to six months without the side effects and addictive qualities associated with opioid pain-killers.
“A lot of these patients are spending the final days of their lives in metastatic disease states really dosed heavily on opiates. It essentially leaves them in like a zombie-like state, because this is such a painful and debilitating condition to be in,” the chief executive told Drug Delivery Business News last year.
The injection was previously approved as a generic with the FDA, but it was shelved when its developer fell ill. Q Biomed picked it up as one of its many pipeline candidates when the company first formed.
Q Biomed is positioning its Sr-89 injection as an affordable and effective alternative to opioids for patients with late-stage cancer. Although the drug is indicated as a pain reliever, Corin believes there is an opportunity to expand the label and market it as a therapeutic.
“The first step is to dust off the ANDA, establish manufacturing facilities, sort of rework it a little bit and get the drug ready for commercial availability, which we’re in the process of doing right now,” he said.
