|GW Pharma Confirms Positive Proof of Data in Schizophrenia|
|By David Fowler|
|Tuesday, 15 September 2015 18:12|
Biopharmaceutical firm GW Pharmaceuticals PLC - ADR (NASDAQ:GWPH) has confirmed positive top line results from exploratory Phase 2a placebo-controlled clinical trial of Cannabidiol in 88 patients suffering from schizophrenia.
These had earlier not responded to first line anti-psychotic medications. Patients were randomized to get CBD or placebo as adjunct therapy.
Through a number of exploratory endpoints, CBD was much better than placebo. The noteworthy difference in PANSS positive sub-scale, Clinical Global Impression of Severity as well as Clinical Global Impression of Improvement.
The proportion of responders on CBD was much more than participants on placebo.
CBD much better than placebo especially in cognition with major differences in sub-domains of particular relevance for improving outlook of people suffering with schizophrenia. The Scale for Assessment of Negative Symptoms demonstrated in favour of CBD reaching statistical significance for patients getting CBD with some leading first line anti-psychotic medications.
CBD’s safety profile was very reassuring with no major bad events. The common adverse events were nausea, diarrhea, headache as well as somnolence. However, there were withdrawals from study because of treatment-related adverse events.
Professor Philip McGuire, Head of the Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, and Principal Investigator of the study, opined that the addition of Cannabidiol to patients medication were only slightly responsive to standard anti-psychotic treatment. He added that the improvements were not related to adverse effects and that the results are important because pharmacology of CBD is unique from existing anti-psychotic medications.
Justin Gover, GW's Chief Executive Officer, opined that the findings show potential role of cannabinoids in neuropsychiatric disease. Gover added that the signals show GW with the prospect of new and distinct cannabinoid neuropsychiatric product pipeline opportunity.
The multi-center, double-blind, placebo-controlled trial enrolled a total of 88 patients and were treated over six weeks.