Insys medicine receives orphan drug status for Infantile Spasms
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Insys Therapeutics, Inc. 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."
"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."
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