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June 25, 2014

FDA grants orphan drug designation to Insys Therapeutics’ pharmaceutical cannabidiol

US-based specialty pharmaceutical company Insys Therapeutics has obtained orphan drug designation from the US Food and Drug Administration (FDA) for its pharmaceutical cannabidiol for treatment of Lennox-Gastaut Syndrome.

By Mekala ShivaramPrasad

US-based specialty pharmaceutical company Insys Therapeutics has obtained orphan drug designation from the US Food and Drug Administration (FDA) for its pharmaceutical cannabidiol for treatment of Lennox-Gastaut Syndrome.

Insys Therapeutics president and CEO Michael Babich said: "With no cure and persistence of seizures with current antiepileptic medications, the orphan drug designation recognises 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.

"With no cure and persistence of seizures with current antiepileptic medications, the orphan drug designation recognises the significant, unmet need that exists among children with this severe form of epilepsy and the teams who provide their care."

"We expect to file an investigational new drug application (IND) for CBD in the second half of 2014."

Insys Therapeutics manufactures pharmaceutical dronabinol and pharmaceutical cannabidiol, with both cannabinoids, at its facility in Round Rock, Texas. Recently, the company submitted a drug master file for its cannabidiol active pharmaceutical ingredient.

The company plans to develop treatments for Dravet Syndrome, another rare form of pediatric epilepsy, in addition to Lennox-Gastaut Syndrome.

Insys Therapeutics is currently evaluating the potential use of pharmaceutical cannabinoid in several additional indications that include adult epilepsy, chemotherapy-induced peripheral neuropathy, addiction in cocaine, heroin and opioids, and glioblastoma.

The company intends to pursue orphan drug designation for other indications that may qualify.

Lennox-Gastaut Syndrome is a severe form of childhood-onset epilepsy that typically manifests between two and six years of age.

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