Insys Therapeutics has obtained orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its pharmaceutical cannabidiol (CBD) to treat glioblastoma multiforme (GBM), a malignant primary brain tumour in humans.
The firm has already been granted ODD to its pharmaceutical CBD to treat Gastaut syndrome and Dravet syndrome, both are rare forms of epilepsy.
Insys Therapeutics president and CEO Michael Babich said: “We are pleased to have received orphan drug designation for this aggressive and often incurable form of brain cancer.
“We look forward to advancing development of this product and offering a potential efficacious treatment for patients.”
Recently, the company signed an exclusive licensing agreement with California Pacific Medical Center on behalf of its Research Institute (CPMCRI).
The agreement was made to license CPMCRI’s patent rights related to the usage of cannabinoids to treat GBM.
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In addition, the company is joining forces with Dr Sean McAllister at CPMCRI with respect to his pre-clinical research on CBD to sensitise GBM to current standard of care chemotherapy treatment.
The company is also assessing the potential use of pharmaceutical CBD in other indication such as adult epilepsy, chemotherapy induced peripheral neuropathy and addiction in cocaine, amphetamines and opioids.
The company produces pharmaceutical dronabinol (THC) and pharmaceutical CBD at its FDA-inspected and Drug Enforcement Administration (DEA) approved facility in Texas.
Insys also submitted a Drug Master File for its CBD active pharmaceutical ingredient.