The situation with CBD never seems to get any clearer. Lawmakers on both sides of the Atlantic seem a little confused about CBD and what to do with it. Here in the UK, CBD is legal as long as it comes from an EU-approved strain of hemp and contains minimal THC. In America, every state has its own laws. That said, hemp-derived CBD is legal on a federal level thanks to the 2018 Farm Bill.
But this ‘legal’ status, isn’t actually clear. In Britain, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees the regulation of medicinal products. The MHRA declared a couple of years back that it views CBD as a medicinal compound due to the therapeutic potential it has. Therefore, all medicines containing CBD must be licensed by the MHRA. Nevertheless, CBD products are allowed as long as they are ‘food supplements’ and don’t make medical claims. Talk about a loophole!
In the states, the MHRA’s job is fulfilled by the Food and Drugs Administration (FDA). As of yet, this federal agency has not said that CBD is safe, and yet it is sold in numerous states.
Although these two bodies can’t seem to reach a final verdict on CBD, both of them have licensed a CBD drug in their respective countries. While the MHRA has approved Sativex for Multiple Sclerosis (MS) related spasticity, the FDA has approved Epidiolex. In this review, we find out exactly what Epidiolex does and why it became FDA-approved.
What Is Epidiolex?
Epidiolex is a cannabis-based drug, the first ever to receive FDA approval. It’s a treatment for two rare forms of epilepsy – Dravet Syndrome and Lennox-Gastaut Syndrome (LGS) – and can be administered to people aged 2 years and up. The drug consists of CBD suspended in sesame seed oil and alcohol, combined with artificial sweetener and a strawberry flavoring.
It has long since been rumoured that CBD can be beneficial in helping seizures. In case you’re unfamiliar with CBD, it’s one of the two primary compounds found in cannabis. Unlike its infamous counterpart, THC, CBD is non-intoxicating and doesn’t cause a high. The fact that CBD was illegal when it could potentially help children with life-threatening epilepsy has been a source of heated debate for a long time.
While formulating the drug, Epidiolex creators, Greenwich Biosciences, ran the largest placebo-controlled, clinical program for Dravet and LGS sufferers in history. Participants in the study had failed treatment with 4-6 other medications. The clinical trials found that Epidiolex significantly reduced seizures compared to the placebo. Notably, 93% of patients were also taking other anti-seizure medications such as Clobazam.
The positive results of the trial led the FDA to approve Epidiolex. Patients can now access the drug if they fail other treatments first. The recommended maintenance dose is 10mg per kilogram of body weight, with a maximum dose of 20mg per kilogram per day.
Is Epidiolex Any Different to Regular CBD?
In essence, Epidiolex is a flavoured CBD tincture. You can buy these online in Britain and the United States, and for a much cheaper price than Epidiolex! This drug retails for over $3000, by the way.
However, none of the CBD oils online or in shops have been approved by the FDA or MHRA. In fact, they are completely unregulated. Since nobody is overseeing these oils, sellers can get away with pretty low-quality oils and nobody will be the wiser. It’s suggested that consumers look for third-party lab reports, but it has been known for companies to forge these in the past.
Furthermore, Epidiolex is extremely high strength. We’re talking about 10,000mg here – that is not a strength you can order online! The highest potency we have seen online is about 1000mg, which is nowhere near in the range of Epidiolex.
Epidiolex was designed to treat specific illnesses. With a high strength, clinical trials to back it up, and FDA approval, Epidiolex is quite different from a standard CBD oil. Although the ingredients are essentially the same, it’s better to opt for a pharmaceutical like Epidiolex if you are trying to treat epilepsy.
Epidiolex Side Effects
Nothing is completely free of side effects. The high strength of Epidiolex means that some patients may experience some common side effects. Similarly to CBD oils, the side effects of Epidiolex are fairly mild.
The Epidiolex website lists the following common side effects:
- Sleepiness
- Decreased appetite
- Diarrhoea
- Increase in liver enzymes
- Weakness
- Trouble sleeping
- Infections
Considering that Epidiolex will be prescribed by a doctor, these side effects are nothing to worry about. You will be given Epidiolex under doctor supervision, and your physician will be able to correct your course of treatment.
Final Thoughts on Epidiolex
Approved in 2018, Epidiolex is a landmark example in the CBD industry. It’s great to see some action in the world of CBD pharmaceuticals, even if progress is slow. Now that Epidiolex is approved, patients who really need CBD can access it legally.
Hopefully, Epidiolex and Sativex are the first of many cannabis-based medications that will bring help to people. Perhaps this is wishful thinking, but drugs like this might also spur the FDA and MHRA into action, forcing them to change their harsh stances on CBD.
