FDA to Approve Cannabis-Based Seizure Medicine

FDA to Approve Cannabis-Based Seizure Medicine

The U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy

The FDA has few weeks remaining to give verdict on the approval of a cannabis-based seizure medicine that is targeted at epileptic patients in the U.S. Once approved, medical patients will be able to buy the drug from pharmacies like other prescriptions. The medicine was created by GW, a pharmaceutical company registered in Britain. The medicine contains 98% CBD and does not have THC, which means it has no psychoactive properties, which makes it ideal for children with epilepsy.

FDA to Approve Cannabis-Based Seizure Medicine

How does Epidiolex work on seizure patients?

Before the drug was passed for production, GW conducted different clinical trials that helped to give answers to the question above. In one study, the company used a group of 171 patients aged between 2 and 55 years, and all these were diagnosed with Lennox-Gastaut syndrome, which is a form of severe epilepsy. The patients took the medicine over a period of time.

After completing 14 weeks of treatment, 44% of patients experienced a reduction in the frequency of seizures and more that took the drug reported up to 50 percent reduction, which helps to validate the power of the drug to help solve seizures among patients. Those who have been asking ‘is epidiolex FDA approved’ will have to wait longer to enjoy the benefits of the medication.

When is sativex FDA approval date?

The federal government has been taking too long to give full approval to cannabis products even when they have proven benefits. As for sativex FDA approval 2017,it seems patients will have to hold on longer as the earliest the FDA will look into this issue is June 27, 2018. If the FDA will pursue a decision that is based on the data collected from the clinical trials, then the approval of Epidiolex is certain. If approved, this will become the first plant-derived drug that will be accessible by patients nationwide.

However, there are few other FDA approved cannabinoids 2017 that show that indeed, the body could also consider this cannabis-based medication if benefits are proved to be real. In 2017, the FDA approved three medicines with synthetic THC. These FDA approved synthetic cannabinoid medications include Cesamet, Syndros, and Marinol. These FDA CBD 2017 approvals also helped to open doors for more applications including the pending approval of Epidiolex.

This was a progressive move and the FDA CBD dietary supplement approvals made so far add on to the victory the medical field has achieved due to focus on the benefits of medical marijuana. Although it has been easy to get approvals for synthetic marijuana products, those with organic marijuana are still struggling to get approval.

The sativex FDA approval 2016 has been an ongoing debate but it seems there will be a conclusion come June 27. Many partners including insurance companies have been waiting for this to be given approval as it seems patients could spend up to $30,000 annually in Epidiolex.

How approval of Epidiolex affects the future of cannabis-based drugs

Many hope that the FDA will approve Epidiolex, and if this happens, then it will be a monumental achievement in the medical industry. This will be like a direct approval from a government agency on the benefits of marijuana and this could also convince the federal authorities to reconsider the cannabis laws. Epilepsy is widely prevalent and many people who have used cannabis-based medications proclaim to the fact they have benefited and would recommend the treatment. The approval of Epidiolex, therefore, will open doors for many more to reap the benefits of marijuana.

How CBD works on seizure patients
Epidiolex is made entirely of CBD and this means its properties will be in line with those of pure CBD or other cannabis products with CBD as the dominant element. CBD has been proved to help patients of epilepsy, particularly in the treatment of seizures and for many years, its results have stood out. CBD is a cannabinoid just like the over 400 that are found in the cannabis plant. These compounds work by binding cannabinoid receptors, which help to modify different functions like your mood, movement, immune response, appetite, sleep habits, and cognition among many other functions.

CBD is a prominent cannabinoid and it lacks the psychoactive properties you will get with THC, and this means you will not get “high” when you consume CBD. One of the benefits of using CBD on patients of epilepsy is that it does not have side effects like many drugs that are given to patients who have seizures. It is only on rare occasions a patient will react to the compound, and this is mostly when one is new to its treatment. Therefore, Epidiolex is expected to possess the same properties as CBD. That’s why many have hopes that Epidiolex will get CBD FDA approved so they can reap the many benefits of the medication.

However, as everyone waits for the approval, the Epidiolex medication is already being used by some people who were given “compassionate use” by the FDA, which is an exception awarded to users on a limited basis as they await approval. Few of those who have had this access have reported that it is helping them cope with seizures and its response is strong and almost instant. Many studies have been done to investigate the medication and most of them have concluded that the Epidiolex drug is also safe and suitable for children suffering from Dravet Syndrome.

Why approval of Epidiolex had been delayed

The FDA does not have issues giving approval to drugs that demonstrate good clinical results like Epidiolex. The only reason it has taken longer to have it approved is because Epidiolex is derived from Cannabis, which is a federally-prohibited Schedule I drug. There are also new rules imposed by FDA that direct that all new trials should be done at hospitals that are licensed and inspected by DEA. But with the fact that the federal government admitted some forms of cannabis are beneficial, this sends a promising sign that the future of medical marijuana is good and Epidiolex will likely get approved. Nonetheless, it’s good to wait and see the response the FDA will give when time comes.

FDA to Approve Cannabis-Based Seizure Medicine

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