CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC).
Epidiolex must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. As is true for all drugs that treat epilepsy, the most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression and panic attacks. Epidiolex also caused liver injury, generally mild, but raising the possibility of rare, but more severe injury. More severe liver injury can cause nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice and/or dark urine.
Epidiolex’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome. Epidiolex, taken along with other medications, was shown to be effective in reducing the frequency of seizures when compared with placebo.
“Even with these currently available treatments, only about 10 percent of patients with Dravet syndrome achieve adequate seizure control,” says Dr. Miller.
So far, the condition has been extremely challenging to treat, with response to medication being inadequate. The participants in this investigation were taking multiple anticonvulsants, such as levetiracetam, divalproex, topiramate, zonisamide, ethosuximide, and clobazam.
Results Show That a Lower Dose Is Safe, Effective
Schultz stresses that dosing above 25 mg did not significantly improve seizure response, but did increase the number of adverse events. “Given that, it makes sense for the top end of dosing to be around 25 [mg],” he says.
The company is also exploring cannabinoid-based therapies for autism, spinal cord spasticity, schizophrenia, and post-traumatic stress disorder (PTSD).
Notoriously Resistant to Treatment
New study supports possible lower dosing levels of FDA-approved drug derived from cannabis for difficult-to-treat type of epilepsy.
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Other Cannabis-Derived Pharmaceutical Medications
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