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CBD for Infantile Spasms Given OK by The FDA

CBD for Infantile Spasms Given OK by The FDA

Infantile spasms Infantile spasmsInsys Therapeutics, Inc. (NASDAQ: INSY)  today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its pharmaceutical cannabidiol (CBD) candidate for the treatment of infantile spasms (IS).

“We are pleased to have received orphan drug designation for CBD to treat infantile spasms, a catastrophic form of childhood epilepsy,” said Michael L. Babich, President and Chief Executive Officer. “If successful, our CBD product could offer certain children the potential to attain seizure control and to potentially achieve an improved level of development. It is also an opportunity to have a significant, positive impact in the lives of these unfortunate children and their families. We are updating our current IND to initiate a clinical trial at UCLA.”

Raman Sankar, MD, PhD, lead investigator for Insys’ planned CBD trial for the treatment of IS with Dr. Shaun Hussain at UCLA, stated, “The population that we are studying in this clinical trial is infants who have failed currently approved therapies for a debilitating disease associated with detrimental effects on their short- and long-term development. I am pleased to be leading this investigation of CBD which, if successful, could offer a new treatment option for these infants for whom there are limited or no currently available therapies.”

Orphan drug designation is granted by the FDA Office of Orphan Products Development to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity upon approval, as well as certain financial incentives that can help support its development.

Insys expects that its new, DEA-inspected facility in Round Rock, Texas, will enable it to manufacture ample quantities of CBD for its research and commercial plans.

About Pharmaceutical CBD

Cannabidiol (CBD) is one of at least 60 active cannabinoids identified in cannabis. CBD is considered to have a wider scope of medical applications than tetrahydrocannabinol (THC), and appears to have anti-convulsive action in animal models.

Insys’ pharmaceutical CBD is over 99.5% pure cannabidiol. It is synthesized to be chemically identical to the CBD extracted from cannabis, and is produced in a controlled environment. The FDA issued a Drug Master File (DMF) to Insys for its CBD active pharmaceutical ingredient in May 2014.

About Infantile Spasms

An infantile spasm (IS), also known as West Syndrome, is a specific type of seizure seen in an epilepsy syndrome of infancy and childhood. West Syndrome is characterized by infantile spasms, developmental regression, and a specific pattern on electroencephalography (EEG) testing called hypsarrhythmia (chaotic brain waves). The onset of infantile spasms is usually in the first year of life, typically between 4-8 months. The seizures primarily consist of a sudden bending forward of the body with stiffening of the arms and legs; some children arch their backs as they extend their arms and legs.(1)an Drug Designation for Its Pharmaceutical Cannabidiol for the Treatment of Infantile Spasms
PHOENIX, AZ–(Marketwired – Aug 4, 2015) – Insys Therapeutics, Inc. (NASDAQ: INSY) (“Insys” or “the Company”) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its pharmaceutical cannabidiol (CBD) candidate for the treatment of infantile spasms (IS).

“We are pleased to have received orphan drug designation for CBD to treat infantile spasms, a catastrophic form of childhood epilepsy,” said Michael L. Babich, President and Chief Executive Officer. “If successful, our CBD product could offer certain children the potential to attain seizure control and to potentially achieve an improved level of development. It is also an opportunity to have a significant, positive impact in the lives of these unfortunate children and their families. We are updating our current IND to initiate a clinical trial at UCLA.”

Raman Sankar, MD, PhD, lead investigator for Insys’ planned CBD trial for the treatment of IS with Dr. Shaun Hussain at UCLA, stated, “The population that we are studying in this clinical trial is infants who have failed currently approved therapies for a debilitating disease associated with detrimental effects on their short- and long-term development. I am pleased to be leading this investigation of CBD which, if successful, could offer a new treatment option for these infants for whom there are limited or no currently available therapies.”

Orphan drug designation is granted by the FDA Office of Orphan Products Development to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity upon approval, as well as certain financial incentives that can help support its development.

Insys expects that its new, DEA-inspected facility in Round Rock, Texas, will enable it to manufacture ample quantities of CBD for its research and commercial plans.

About Pharmaceutical CBD

Cannabidiol (CBD) is one of at least 60 active cannabinoids identified in cannabis. CBD is considered to have a wider scope of medical applications than tetrahydrocannabinol (THC), and appears to have anti-convulsive action in animal models.

Insys’ pharmaceutical CBD is over 99.5% pure cannabidiol. It is synthesized to be chemically identical to the CBD extracted from cannabis, and is produced in a controlled environment. The FDA issued a Drug Master File (DMF) to Insys for its CBD active pharmaceutical ingredient in May 2014.

About Infantile Spasms

An infantile spasm (IS), also known as West Syndrome, is a specific type of seizure seen in an epilepsy syndrome of infancy and childhood. West Syndrome is characterized by infantile spasms, developmental regression, and a specific pattern on electroencephalography (EEG) testing called hypsarrhythmia (chaotic brain waves). The onset of infantile spasms is usually in the first year of life, typically between 4-8 months. The seizures primarily consist of a sudden bending forward of the body with stiffening of the arms and legs; some children arch their backs as they extend their arms and legs.(1)

 

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4 Comments

  1. Hi All,

    My baby is 4 months 10 days old he have same symptoms and i have checked with doctor and they have suggested to give ACT steroid 0.4 ml for 10 days continuously after that alternate days for 2 weeks and epilepsy syrup 2 ml 3 times for the day and topamax 6.50 mg 1 time from (06/October/2016). Please kindly explain this is curable disease for my baby to lead the normal life.

    Still now he was active and giving response head and neck is holding right now from last 20 days. This Jerk movement is happens every time of weak-up from the bed and while sleeping feeding milk.

    Reply
    • Profile photo of EpilepsyU

      It may be a temporary thing for your baby. If your baby is having fevers it could be what is called febrile seizures brought on by them. If it isn’t temporary there is still hope. Many children do outgrow their epilepsy/seizures. In the meantime I would be sure to follow doctors order.

      Best wishes and good luck.
      Chuck

  2. Thank you Carmen

    Reply
  3. My grandson developed bacterial meningitis at just over a month old. He spent several weeks in icu, most intibated. He started having seizures in this time. His seizures are mostly controlled by the many meds he is on, however he has started having these infantile spasms (diagnosed by his neurologist) they’ve added very high doses of prednisone which doesn’t seem to be stopping the spasms, actually they seem to be getting worse or more frequent. We are so desperate for alternate options!

    Reply

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