FDA approves first drug derived from marijuana for epilepsy treatment - Sovereign Health Group
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FDA approves first drug derived from marijuana for epilepsy treatment
06-27-18 Category: Marijuana

FDA approves first drug derived from marijuana for epilepsy treatment

In a first, the Food and Drug Administration (FDA) has approved a drug derived from marijuana for the treatment of two extreme forms of epilepsy – Lennox-Gastaut and Dravet syndromes. Both the epilepsy forms are incapacitating and are responsible for early mortality. Patients living with these syndromes could suffer from several recurrent seizures in a day and life span is reduced drastically.

The decision to clear the drug, Epidiolex, manufactured by GW Pharmaceutical, was on expected lines. However, there were concerns over the way the drug may impact the liver. Some experts believed that once doctors start prescribing the drug, they would also find ways to monitor patients during treatment for any possible side effects. Epidiolex not only had the support of the FDA officials who indicated beforehand that they approved of it, but also of the advisory board which had unanimously recommended it.

High CBD content

Epidiolex is high in cannabidiol or CBD, a component in marijuana which does not cause the high like another active component tetrahydrocannabinol or THC. The treatment is administered in the form of an oil and clinical trials have revealed that the medicine effectively reduced the number of seizures in patients with a Dravet and Lennox-Gastaut syndromes to 40 percent. In evidence in the first few years of life itself, the symptoms of Lennox-Gastaut and Dravet emerge early.

Because of the debilitating seizures, patients have a reduced quality of life. Unfortunately, while there are five other drugs approved by the FDA for treating Lennox-Gastaut, there is no medication for treating Dravet. For the time being, the drug has been approved for the treatment of Lennox-Gastaut and Dravet only. However, experts believe that it will soon be used for the treatment of all other forms of epilepsy as well off-label.

New beginning

The FDA move certainly marks an epoch in the treatment of the highly debilitating condition with once completely prohibited weed. According to FDA Commissioner Dr. Scott Gottlieb, the approval is a reminder that sound development programs which have properly evaluated the active ingredients contained in weed can lead to significantly important medical therapies.

The approval by the FDA also realizes the efforts of GW Pharmaceuticals, the company which had been working for epilepsy patients as well as their families and physicians to develop a cure for the condition that has disrupted many lives. In a statement, GW CEO Justin Gover said, “These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”

Fear of marijuana abuse

However, the FDA approval has also led to the usual fear of marijuana abuse as it involves the risk of turning the United States into a nation of weed junkies. But allaying such fears, Dr. Gottlieb said the FDA approval did not imply that the agency has approved marijuana or all its components. He specified that the approval was for one specific CBD medication and for a specific purpose only.

The FDA chief said there would be additional enforcement actions against pharmaceutical companies if they sell CBD as a miracle cure without clinical evidence. This being the case with a number of for-profit organizations that sold marijuana as a cure for Alzheimer’s disease or cancers. The FDA in the past had sent out warning letters to these companies.

Reclassifying marijuana

Even before GW begins marketing Epidiolex , the Drug Enforcement Administration (DEA) will have to reclassify CBD as it is an active component of marijuana, which is a Schedule I drug with high risks of abuse and no known medicinal value.

Considering that the FDA had in the past approved synthetic medications which were identical to THC and had these drugs listed under Schedule II and Schedule III, or drugs with a medicinal value but also potential for abuse, this should not pose as a problem.

Finding cure for drug abuse

Though marijuana has often been touted as a miracle cure for several ailments, its misuse can be as devastating as that of cocaine and heroin. It can lead to addiction and dependency. If abused regularly, marijuana may act as a gateway drug leading to addiction to stronger substances.

Be it marijuana or any other substance, addiction is a treatable condition. If you or a loved one require help of marijuana addiction rehab, Sovereign Health can help. We offer customized marijuana addiction treatment programs to our patients to ensure complete and long-term recovery. Call at our 24/7 helpline or chat online with our representative to get in touch with our marijuana addiction rehab center near you.

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