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news.The US Food and Drug Administration (FDA) has granted orphan drug designation to Insys Therapeutics' pharmaceutical cannabidiol (CBD) to treat Lennox-Gastaut Syndrome, a rare pediatric-onset epilepsy.
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Insys manufactures pharmaceutical dronabinol (THC) and pharmaceutical CBD at its FDA-inspected and Drug Enforcement Administration (DEA) approved facility in Round Rock, Texas.
Recently, Insys submitted a drug master file for its cannabidiol active pharmaceutical ingredient.
Insys Therapeutics president and chief executive officer Michael Babich said with no cure and persistence of seizures with current antiepileptic medications, the orphan drug designation recognizes the significant, unmet need that exists among children with this severe form of epilepsy and the teams who provide their care.
"We have the unique opportunity to test a controlled pharmaceutical CBD product for Lennox-Gastaut Syndrome, and our company is committed to advancing cannabinoid therapies that have the potential to provide significant medical benefits to patients across multiple indications," Babich said.
"We expect to file an Investigational New Drug Application (IND) for CBD in the second half of 2014."
Apart from Lennox-Gastaut Syndrome, the company plans to develop treatments for Dravet Syndrome, another rare form of pediatric epilepsy.
The company is also evaluating the potential use of pharmaceutical CBD in several additional indications, such as adult epilepsy; chemotherapy-induced peripheral neuropathy; addiction in cocaine, heroin and opioids; and glioblastoma.