GW Pharmaceuticals PLC GWPH disclosed that FDA has accorded Orphan Drug Designation for its Cannabidiol for the treatment of Tuberous Sclerosis Complex (TSC). According to the company, TSC was a rare genetic disorder, the most common symptom of which is epilepsy.
GW Pharmaceuticals indicated that epilepsy happens in about 80–90 percent of TSC patients and was a significant factor of morbidity and mortality. The company said TSC was the third orphan indication that the company was focusing within its Epidiolex clinical development program including four Phase three pivotal studies in Dravet Syndrome and Lennox-Gastaut syndrome.
On April 11, the company indicated it initiated a Phase 3 clinical trial of Epidiolex as an adjunctive therapy for the treatment of seizures associated with TSC.
The company's shares traded 2.15 percent higher at $88.09 early Thursday morning.
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