GW Pharmaceuticals, a biopharmaceutical company, has developed a CBD epilepsy drug. Given the brand name Epidiolex, it treats rare, drug-resistant forms of epilepsy such as Dravet, or Lennox-Gastaut (LGS) syndromes. Epidiolex reduces life-threatening seizures. Researchers say it is safe and well-tolerated by children, even when they are very young.
Pharma Times reports that Epidiolex received orphan drug status in Europe for LGS.
Professor of Neurology at the Harvard Medical School, Elizabeth Thiele, MD, Ph.D., and Director of Pediatric Epilepsy Massachusetts General Hospital, was the chief investigator in the Epidiolex trial for LGS. She commented that she was looking forward to the day Epidiolex will be available for her to prescribe to her patients
Orphan drug status incentive
Orphan drug status gets awarded to drugs as an incentive to Pharmaceutical companies to develop safe and effective treatments for the prevention or treatment of rare diseases affecting less than 200,000people. The incentive might include tax reductions and the exclusive right to develop a cure for a condition for up to seven years.
Drugs for common illnesses don’t need this incentive. After all, if they become standard treatments, there is a big market. But developing drugs for rare conditions is less profitable, hence the incentive.
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Epidiolex awarded European Orphan status
European regulators have granted Epidiolex Orphan status after examining data from two late-stage trials. These revealed that when doctors add Epidiolex to a current treatment regimen, patients experienced significantly fewer drop seizures.
One of the trials, conducted over 14 weeks, showed that the CBD epilepsy drug reduced seizures by 44% in comparison to 22% in the placebo group.
Ready to register CBD epilepsy drug
Justin Gover, CEO of GW confirmed the company is busy with applications to market Epidiolex for LGS in the US by mid-2017. The company will submit an application to the European Medicines Agency will shortly after that.
Gover said that GW was very pleased with the results from two Phase 3 studies. The CBD epilepsy drug offers hope for those with the two most untreatable forms of epilepsy. He said the company is looking forward to the launch of this new and important medicine. The company hopes to make it available to patients in need as soon as possible.
Doctors have been waiting to prescribe Epidiolex
Orrin Devinsky, M.D., of the Comprehensive Epilepsy Center at New York University Langone Medical Center, said the medical community has been waiting eagerly to prescribe this standardized and tested pharmaceutical formulation of cannabidiol.
However, there are some who worry that just using CBD could be second prize. They believe in the Entourage Effect. This theory says that all the ingredients in cannabis are needed to work together synergistically.
That having been said, Epidiolex represents an important advance in the science of cannabis. As a pharmaceutical, access will be much easier than it is now. Doctors will also feel more confident about prescribing CBD.