CARLSBAD, Calif. — GW Pharmaceuticals announced Nov. 1 that its epilepsy drug Epidiolex is now available by prescription. The first ever cannabis-based medication approved by the US Food and Drug Administration was approved in June.
Epidiolex is an effective treatment for the two most severe forms of the disease, Dravet syndrome and Lennox-Gastaut syndrome.
Dravet Syndrome is a condition that causes multiple daily seizures causing one in five patients with the disease to die before reaching the age of 20. Lennox-Gastaut syndrome also causes multiple seizures, does not respond to traditional anti-seizure drugs, begins in early childhood, causes severe intellectual disabilities, and has no cure.
Epidiolex can decrease seizures up to 50 percent and is approved for children ages 2 and up with Dravet syndrome or Lennox-Gastaut syndrome. The strawberry-flavored oral solution is administered twice-daily.
Epidiolex is Covered by Most Insurance Plans
Justin Gover is the CEO of the drug's manufacturer, GW Pharmaceuticals, and says that the company's goal in making the medicine was to decrease the number and impact of seizures for patients, adding "We are committed to ensuring that these patients can access this novel cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and is eligible to be covered by insurance for appropriate patients."
The price of Epidiolex is approximately $32,500 a year but is expected to be covered by most insurance plans. One 100 ml bottle of the Epidiolex will cost $1,235, according to the spokesman for GX Pharmaceuticals Stephen Schultz.
The UK-based GW Pharmaceuticals has also introduced a comprehensive patient support program to help patients pay for the out-of-pocket costs associated with prescriptions. The program is called Epidiolex Engage and will provide education and resources for patients prescribed Epidiolex.
Executive Director of the Lennox-Gastaut Syndrome Foundation Christina SanInocencio is pleased that the drug is finally available for patients in need. "Despite the use of multiple epilepsy treatments, the majority of LGS patients continue to have life-long, debilitating seizures and our community welcomes the availability of a new, first-in-class treatment option."
Mary Anne Meskis is the Executive Director of the Dravet Syndrome Foundation and is also happy that the drug is finally available.
"Our community has long desired a medication specifically approved for the treatment of seizures associated with Dravet syndrome, and the availability of Epidiolex is an important milestone for patients and caregivers whose lives are significantly impacted by this catastrophic, lifelong form of epilepsy," said Meskis.
Side effects may include a decrease in appetite, diarrhea, fatigue, an increase in liver enzymes, infections, insomnia, sleepiness, and rashes.
While the drug is an effective treatment for Dravet syndrome and Lennox-Gastaut syndrome, the lead physician on the two of the clinical trials for the drug says that it is not a miracle cure. Dr. Orrin Devinsky is also the director of the Comprehensive Epilepsy Center at NYU Langone Health and says that Epidiolex works better for some than others.
"There are some people who had dramatic improvements. Many had a modest improvement, and some had no improvement. So, it’s not a miracle drug. It’s an effective drug, and I think its side effect profile is quite good compared to other seizure drugs that we have, but it’s not a miracle cure," Devinsky concluded.
Epidiolex decreased convulsive seizures (also known as drop seizures) by 25-28 percent when used with other anti-seizure medications, which the doctor considers a modest improvement.
FDA Commissioner Dr. Scott Gottlieb said that the FDA will continue to support rigorous scientific research on medical marijuana's potential and is ready work with manufacturers who want to provide safe and effective medications to patients.