SILVER SPRING, Md., July 31, 2020 /PRNewswire/ -- Today, the Tuberous Sclerosis Alliance (TS Alliance) lauds the U.S. Food and Drug Administration's (FDA's) approval of Epidiolex® oral solution to treat seizures in people one year of age and older who have tuberous sclerosis complex (TSC). Affecting approximately 50,000 in the United States and 1 million worldwide, TSC is a genetic disorder that causes non-cancerous tumors to form in vital organs; it's also the leading genetic cause of both epilepsy and autism.
"Up to 85 percent of those affected by TSC experience seizures at some point in their lifetime," explained TS Alliance President & CEO Kari Luther Rosbeck. "Unfortunately, existing medications don't always effectively control them. Our organization and the TSC community certainly welcome a new option such as Epidiolex, which is the second FDA-approved drug specific to TSC."
Manufactured by GW Pharmaceuticals and distributed in the United States by Greenwich Biosciences, Epidiolex is a plant-derived cannabinoid prescription medicine and the only current FDA-approved form of cannabidiol (CBD). In 2018, the FDA approved the drug to treat people two years of age and older with Lennox-Gastaut syndrome (LGS) or Dravet syndrome.
"We are grateful for the dogged commitment of GW Pharmaceuticals and especially for the TSC clinical trial volunteers, researchers and clinicians who made this possible," said TS Alliance Chief Scientific Officer Steven L. Roberds, PhD. "Epidiolex provides a standardized formulation of CBD with evidence of effectiveness supported by rigorous, well-controlled clinical trials."
Established in 1974, the Tuberous Sclerosis Alliance is an internationally recognized nonprofit organization dedicated to finding a cure for tuberous sclerosis complex while improving the lives of those affected. The organization accomplishes this by developing programs, support services and resource information; stimulating and sponsoring research; and creating and implementing public and professional education programs designed to heighten awareness of the disease. For more information, visit tsalliance.org or email [email protected].