UK Cannabis Biotech gets another Orphan Drug Designation by the FDA

22/04/2016 - 2 minutes

Cambridge based GW Pharmaceuticals has now been granted Orphan Drug Designation from FDA for Cannabidiol drug to treat a 3rd rare genetic form of epilepsy.

GW_PHARMA_biotech_fda_orphan_tuberous_SclerosisGW Pharmaceuticals has been granted Orphan Drug Designation for cannabidiol (CBD) for the treatment of Tuberous Sclerosis Complex (TSC). Epidiolex is a liquid formulation of pure plant-derived CBD, which is in development for the treatment of a number of rare pediatric epilepsy disorders.

GW Pharma recently began a phase III trial with 200 patients with TSC, and will last for 16 weeks. If the results are positive, this new Orphan Drug Designation could really speed the market authorization in the US.

TSC is a rare genetic disorder, the most common symptom of which is epilepsy. Epilepsy occurs in around 80-90% of TSC patients and is a significant cause of morbidity and mortality.

It causes non-malignant tumors to form in many different organs, primarily in the brain, eyes, heart, kidney, skin and lungs. However,

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