The US Food and Drug Administration (FDA) has officially approved a drug called Epidiolex which contains cannabidiol (CBD).
The preparation in form of strawberry syrup will be used in the treatment of patients with epileptic syndromes (dravet syndrome and Lennox-Gastaut syndrome) between 2 years old and older.
Dravet syndrome: a rare genetic brain dysfunction, which is most often diagnosed in early childhood
Lennox-Gastaut syndrome: the form of epilepsy with multiple types of epileptic seizures that appear in early childhood, usually between 3 and 5 years of age.
“This is an important advancement in the treatment of children’s epilepsy,” said FDA Commissioner Scott Scott Gottlieb on Monday.
“Due to the efficacy and safety of the use of Epidiolex confirmed in clinical trials in patients, an official agreement was finally approved on the possibility of using this drug in the treatment of certain types of epilepsy,” adds Gottlieb.
On the website of the producer, a biopharmaceutical company GW Pharmaceuticals dealing with the discovery, development, and commercialization of new drugs, Epidiolex is the first (available by medical prescription) pharmaceutical formulation containing a high content of purified cannabidiol (CBD) of plant origin that does not cause intoxicating.
“The approval of Epidiolex is a milestone in the use of a cannabidiol for the treatment of neurological disorders. This is the first and so far the only CBD drug that can be used to treat two types of epilepsy in children. We would like to say that we have high hopes for the introduction of Epidiolex for medical treatment, “
said Justin Gover, CEO of GW.
“The FDA approval of our drug is the culmination of the long-term cooperation of GW Pharmaceuticals with patients, their families, and doctors to develop a new preparation that would be helpful in the fight against epilepsy. Patients deserve it and soon will have access to a CBD-containing drug that has been thoroughly tested in clinical trials, meets all the pharmaceutical product quality criteria and will be available as a prescription from a doctor “ – Justin Gover.
“In my medical practice, I had many patients who suffered from drug-resistant epilepsy. In such patients, the treatment regimens used so far most often did not bring the expected results, which is why these patients often asked about the possibility of using CBD “ – said Dr. Orrin Devinsky of the Epileptic Treatment Center at NYU Langone Health, and also one of the main clinical trial managers of Epidiolex.
“I am glad that my colleagues – doctors and I will be able to use Epidiolex, which has successfully undergone clinical trials and has been approved by the FDA.” – added the doctor.
A difficult pediatric epilepsy
Elizabeth Thiele, director of the pediatric clinic at the General Hospital in Massachusetts, professor of neurology at Harvard Medical School and chief scientist in clinical trials with the drug Epidiolex mentions that the Lennox-Gastaut and Dravet teams are two of the most difficult to control forms of pediatric epilepsy.
“These children and their families face a long and difficult path, and very few achieve adequate seizure control. This drug supplements a specific pharmacological gap dedicated to a specific population of pediatric patients and is now the first that has been approved by the FDA for the treatment of Dravet syndrome. ” – Thiele adds.
The clinical trial program for Epidiolex
The clinical trial program for Epidiolex included three randomized, double-blind clinical trials and an open-label extension study.
From articles published in the New England Journal of Medicine and Lancet scientific journals, it appears that the addition of Epidiolex to other anti-epileptic therapies has resulted in a significant reduction in seizure frequency in patients with Lennox-Gastaut syndrome and Dravet.
Side effects of Epidiolex Cannabidiol (CBD) Oil
Although Epidiolex is a safe preparation, the following side effects may occur during its administration
- Reduced appetite
- Increase in liver transaminases
- Malaise and asthenia (weakness)
- Sleep disturbances or infections
In conclusion, it is worth adding that GW Pharmaceuticals plans further expansion and has already applied for permission to market Epidiolex to the European Medicines Agency (EMA). The decision in this matter will most likely be made in the first quarter of 2019.
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