With the breaking news of the cannabis-derived Epidiolex, a new drug that was recently approved by the Food and Drug Administration (FDA), we here at PuffPuffPost thought we’d give our readers a comprehensive pharmacological view on Epidiolex.
Epidiolex (cannabidiol) is the first FDA approved cannabidiol-based (CBD) medication on the market, manufactured by UK-based GW Pharmaceuticals as an oral solution. A comprehensive pharmacological view on Epidiolex helps to determine its properties. The drug is to treat seizures associated with Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome, two types of rare epileptic syndromes with childhood onsets, in patients two years of age and older.
Prior to Epidiolex treatment, prescribing physicians will obtain serum transaminases like AST and ALT, which are liver enzymes, due to the fact that the drug can potentially cause liver injuries. The drug is metabolized by the CYP3A4 and CYP2C19 enzymes within the liver, and excreted mainly through defecation. Patients with any liver conditions will more than likely not be prescribed the drug. Patients are encouraged not to drive, operate heavy machinery, or do other dangerous activities until they are aware of how Epidiolex affects them since it can be a sedative.
Epidiolex is to be administered orally with a syringe, and the starting dosage is recommended to be at 2.5mg twice daily. Patients are to note that food may affect the dosage of the drug.
Side effects can vary from mild to severe
Some of the contraindications or side effects associated with Epidiolex are allergies or aversion to the ingredients – mainly cannabidiol, hepatic (liver) injuries, increase in creatinine levels, sedation, suicidal behaviour and ideations, insomnia, anxiety, panic attacks, and mania. Patients are encouraged to monitor their behaviour after taking cannabidiol for the above symptoms and to reach out to their physician immediately if they notice any changes.
In vitro data shows that caffeine and drugs like theophylline may interact with Epidiolex, which causes a decreased effect of the drug. Use of Epidiolex with other Central Nervous System (CNS) depressants may increase the risk of sedation. There is no adequate data on the developmental risks associated with the use of Epidiolex in pregnant and breastfeeding women. Administration of cannabidiol to pregnant animals produced evidence of developmental toxicity at maternal blood exposures, so physicians do not recommend pregnant and breastfeeding women to take the drug. In elder use, patients will be given low doses as not to cause impairment.
As part of the FDA’s review of the medication, the potential for abuse was assessed and found to be low to negative. The exact mechanism of action of Epidiolex is uncertain, but research shows that the drug does not appear to exert its anticonvulsant effects through interaction with the body’s endocannabinoid receptors.
The excitement behind the approval of Epidiolex has to do with the fact that The Drug Enforcement Administration (DEA) continues to categorize cannabis as a Schedule I drug with no medical use and a high potential for abuse. But now the FDA challenges that notion with its approval of the cannabis-based drug.
Epidiolex will be released in the fall of 2018, but there has been no word on costs, although it can be certain that insurance companies will have their input.