EU has approved medicinal cannabis for the first time as a potential treatment for two rare and severe forms of childhood epilepsy.
Doctors don’t recommend Epidiolex, the herbal oral suspension as a long term treatment option for the children with Dravet syndrome or Lennox-Gastaut syndrome. However not all the parents are satisfied with it and want an alternative consisting of a component not included in this drug.
CBD or cannabidiol is a chemical component of the Cannabis sativa plant, famous as marijuana. CBD doesn’t cause euphoria or high in the consumers. Basically, it is the THC that is the main psychoactive component of Cannabis.
Epidiolex is 100% free of this psychoactive component, tetrahydrocannabinol or THC. Due to this, parents don’t find this drug as useful as with THC and come up with the observation that this treatment is not effective for the children. They state its reason for lacking THC which is actually helpful in reducing the frequency of seizures in epilepsy.
The medication introduced by GW Pharmaceutical as a treatment for epilepsy would be used in combination with clobazam which is another epilepsy medication.
Is this medicinal cannabis approved worldwide or not?
The US Food and Drug Administration FDA approved the Epidiolex last year for the first time as the treatment for Dravet syndrome. It is a rare genetic disease with frequent fever-related seizures.
In a statement, FDA Commissioner Scott Gottlieb said, “This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development.”
On the other hand, CHMP- the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Humans Use also has a positive opinion about the recommendation of this product.
The CHMP’s positive opinion depends on the results from 4 trials including 714 members suffering from either Dravet Syndrome or Lennox- Gastaut syndrome. The results demonstrate that the frequency of seizures may be lesser with cannabidiol products instead of a placebo.
UK also approved this oral solution; however, NHS doesn’t recommend its use currently. A month ago, due to the absence of evidence of its long haul viability, the UK’s National Institute for Health and Care Excellence settled on an initiative decision about not recommending the prescription of Epidiolex.
Legal Medicinal Cannabis Products Containing THC
Many other cannabis products containing THC are also legal in the UK. But only a specialist doctor can prescribe these medicines. That too, only in the case if all other medicines fail to work on a patient.
Nabilone is a cannabis-based medicine, legal in the UK. It is available in the form of capsules and works in a similar way to tetrahydrocannabinol or THC. This drug may help people with nausea in the case of chemotherapy.
Sativex is also a drug from cannabis plant consisting of both THC and CBD. This drug is also legal in the UK to help people with multiple sclerosis.
Epidiolex is not a Magical Bullet
Extensive trials and clinical studies also prove the efficacy of this cannabis-derived drug. A Professor of Neurology at UCL and Medical Director at Epilepsy Society, Ley Sander said:
“This is good news for children with some of the most serious forms of epilepsy. Epidyolex has been clinically trialed to prove its efficacy and safety so, where appropriate, physicians will be able to prescribe it in the knowledge that there is evidence to support its use.”
“Epidyolex has been through extensive clinical trials and although not a magic bullet, we know that it may work for some children whose seizures do not respond to current treatment options. But like all anti-seizure drugs, it would seem that Epidyolex may work for some children but not for others.”
In short, this positive step made by the EU for the approval of Epidiolex as a treatment for epilepsy will bring hope among the people suffering from deadly disease. However, restorative cannabis, in any case, will remain a question mark and there are many obstacles ahead to approve its marketing authorization.