Spain becomes yet another Country to approve a Cannabis-based Drug

The number of countries recognizing the benefits of medical cannabis is ever increasing. Spain became yet another country to approve a cannabis-based drug for medical use.

The Health Ministry of Spain approved Epidiolex to treat rare seizure disorders. It is a medication that may help in rare kinds of resistant epilepsy. These diseases are Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS). 

Spain is not the first country to provide regulatory approval to the drug, but like many other countries, it has some distrust in the product.

Earlier, this particular product was approved by the US FDA and UK MHRA. The European Medical Agency also approved this drug for use in DS and LGS, and it now enjoys the status of an orphan drug. It is used to treat this rare type of epilepsy first diagnosed in children. Thus, generally, it is approved for use in children older than one year of age. 

Both DS and LGS do not seem to respond well to existing drugs. There are many other issues when treating these seizures. Since these conditions occur in children, many potent drugs cannot be used in this population group. On the contrary, approval for cannabis-based medicines in this young population group says something about it’s safety.

Although all countries in the EU must follow the directives of the European Medical Agency,  in practice it is not the case. Some local laws may have greater importance over EU legislation. 

It is true that generally, all EU member states must allow the sales of drugs approved by the European Medical Agency. However, some countries may ban the use of some medications or ask for additional safety data. Especially if the government thinks that the substance poses some specific health threat to their population. Such an approach has logic, as the EU has member states with quite diverse geographies and genetics.

It means that despite the earlier approval by the European Medical Agency, Epidyolex was not approved for use in Spain. It is because Spain did not differentiate between recreational and medical cannabis. Thus, local laws prohibited the use of any substance that contained THC amounts, greater than 0.02% or synthetic cannabinoids.

However, this latest approval came based on the results of the local clinical trial of the medication. It was a trial with 700 participants. The study found that Epidyolex could help reduce seizures in refractory epilepsy of young by as much as 40%. That is a statistically significant benefit. 

Slowly and gradually, it appears that attitudes of various nations are changing towards CBD and medical cannabis. Therefore, it is quite possible that more studies would be done regarding the impact of legalizing cannabis in the near future.

Lastly, there are high chances that many other cannabis derived medications would get approved for other health concerns in the future. Moreover, once the few cannabis-based medicines are approved, resistance for other newer drugs would be less. Thus, it would be more straightforward for others to get regulatory approvals.

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