Cannabis-based treatment scores Phase 3 successes for GW Pharma
pharmafile | December 6, 2016 | News story | Manufacturing and Production, Research and Development | GW Pharma, cannabidiol
UK-based GW Pharmaceuticals, a biopharmaceutical firm focused on the development of novel cannabinoid therapies, has unveiled new efficacy data for Epidiolex (cannabidiol or CDB) in the treatment of Dravet syndrome and Lennox-Gastaut syndrome (LGS).
Both Phase 3 studies reached their primary endpoints, showing a “statistically significant” improvement in in reducing seizure frequency over 14 weeks compared to placebo; this efficacy was established early in the trials. A consistent separation of Epidiolex and placebo was also observed in all response rates at the 50% seizure reduction threshold, according to drop seizure responder analysis.
The research follows positive Phase 3 data released in September this year, which sent share prices soaring for the company.
“We are pleased to present key findings from two pivotal Phase 3 studies of Epidiolex and believe these additional positive data reinforce the robust nature of the results achieved in two of the most difficult-to-treat epilepsy patient populations,” stated Justin Gover, GW’s Chief Executive Officer. “We are making very good progress toward a NDA submission to the FDA as well as preparations for commercial launch and look forward to the opportunity to make this important new medicine available to patients as quickly as possible.”
Both illnesses are known to prove resistant to treatment. An epileptic condition associated with mutation in the sodium channels, Dravet syndrome occurs within a child’s first year and can cause seizures which can evolve into more serious forms such as tonic-clonic, myoclonic and even prolonged bouts of seizures, in addition to intellectual and developmental disabilities.
LGS affects up to an estimated 50,000 across the US and Europe and typically manifests in patients between three and five years and patients can suffer non-convulsive, convulsive and drop seizures. It can be caused by brain malformations, severe head injuries, central nervous system infection or inherited metabolic or degenerative conditions, though in up to 30% of sufferers, no cause can be identified.
“Dravet syndrome and Lennox-Gastaut syndrome are diagnosed in early childhood and represent some of the most difficult types of epilepsy to treat. Nearly all patients continue to have uncontrolled seizures and other medical needs throughout their lifetime. These trial results show that Epidiolex offers much needed new hope for children and their families,” added Elizabeth Thiele, director of Pediatric Epilepsy at the Massachusetts General Hospital, Professor of Neurology at the Harvard Medical School and Principal Investigator of the LGS trial. “I very much look forward to the day when Epidiolex is available as a new prescription option for my patients.”
Principal investigator of the Dravet syndrome trial Orrin Devinsky, of New York University Langone Medical Center’s Comprehensive Epilepsy Center, also noted:“These placebo-controlled studies demonstrate that Epidiolex provides clinically meaningful reductions in seizure frequency together with an acceptable safety and tolerability profile. The epilepsy community has been eagerly anticipating the presentation of this high quality scientific data from the Epidiolex program at the American Epilepsy Society. My colleagues and I are excited at the future prospect of prescribing an appropriately standardized and tested pharmaceutical formulation of cannabidiol.”
Matt Fellows
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