INSYS Begins Phase 3 CBD Trial

INSYS Therapeutics (NASDAQ:INSY) announced the start of its phase 3 clinical trial studying cannabidiol (CBD) oral solution treating infantile spasms rare type of pediatric epilepsy that occurs in very young children.

As quoted in the press release:

“We need better treatments for infantile spasms, one of the more severe and dangerous seizure disorders of early childhood,” said Shaun Hussain, M.D., a pediatric neurologist at UCLA Mattel Children’s Hospital and director of its Infantile Spasms Project. “That’s why we’re excited about this pivotal study, which has the potential to reveal a new piece of the treatment puzzle for infantile spasms.”

In previous studies, CBD—one of the main molecules in cannabis—has demonstrated sustained clinical benefits in a variety of medically refractory pediatric epilepsies, including infantile spasms, an uncommon condition estimated by the Child Neurology Foundation (CNF) to be diagnosed in about 1,200 children in the United States each year.

“We have great hope in the potential of our proprietary formulation of pharmaceutical-grade, synthetically manufactured CBD oral solution in combination with vigabatrin to offer greater seizure control to children with infantile spasms,” said Steve Sherman, senior vice president of regulatory affairs for INSYS Therapeutics. “The need for more efficacious and better tolerated products to treat this devastating disorder continues to motivate us to advance this investigational therapy through the clinical and regulatory pathway.”

Click here to read the full press release.