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GW Pharma “Epidiolex” Could Be First FDA-Approved Cannabis Therapy

GW Pharma “Epidiolex” Could Be First FDA-Approved Cannabis Therapy

Posted by Marijuana Doctors on 10/17/2016 in Medical Marijuana

Cannabis therapy refers to the use of cannabis to help treat various conditions and diseases and to improve the quality of life for patients by relieving debilitating symptoms. Therapeutic cannabis is available in a number of forms and can be administered in many different ways. Despite both anecdotes and research showing the effectiveness of therapeutic cannabis, the U.S. Drug and Food Administration has yet to approve a cannabis therapy. However, GW Pharma’s Epidolex, which is intended to treat the Lennox-Gastuat syndrome, could be the first FDA-approved marijuana epilepsy treatment, a cannabidiol (CBD) oil, derived from cannabis.

What Is Lennox-Gastuat Syndrome?

According to the Epilepsy Foundation, the Lennox-Gastuat syndrome is a form of epilepsy. Those who suffer from Lennox-Gastuat usually experience more than one type of seizure. The types of seizures most common among sufferers of this syndrome include atonic (drop) seizures and tonic (stiffening) seizures. The intellectual development of individuals with Lennox-Gastuat is usually impaired, but not always. The EEG for patients with this syndrome usually exhibit background slowing and bursts with frequencies of slower than 2.5 per second. For 25 percent of the children suffering from this disorder, the cause of Lennox-Gastuat is unknown.

Lennox-Gastuat Syndrome is fairly rare, as it only accounts for less than 5 percent of all childhood epilepsies. However, the seizures associated with Lennox-Gastuat syndrome are difficult to control. Therefore, children with this syndrome usually need treatment all their lives. The behavioral and intellectual problems often caused by this syndrome only serve to make living with this syndrome even more difficult. All health care professionals are familiar with LGS because this syndrome usually doesn’t dissipate by the time the patient reaches adulthood.

While new treatments for LGS have emerged in the past few years, there is still no cure for the syndrome. Many health care professionals view Epidiolex as having major promise in terms of its effectiveness as a treatment for LGS.

What Is the Epidiolex Drug?

Recently, GW Pharmaceuticals, which is a British biotech company, announced that Phase 3 of the clinical trials for the Epidiolex drug produced positive results. The Epidiolex drug epilepsy medication is not marijuana. Rather, this medication is cannabidiol (CBD) based. The purpose of Epidiolex is to help treat children and adults suffering from Lennox-Gastuat syndrome, which is a rare type of epilepsy that begins during childhood.

During Phase 3 of the clinical trials, patients who took 20 milligrams of Epidiolex saw a 42 percent drop in the number of seizure episodes they experienced a regular basis. On the other hand, the patients who took a placebo experienced just a 17 percent drop in the number of seizure episodes they experienced. The patients who took 10 milligrams of Epidiolex experienced a 37 percent drop in the number of seizure episodes they experienced.

Now that the Epidiolex drug has proven itself to be a success during Phase 3 of the clinical trials, the next step for the British biotech company is to ask for approval from the FDA. GW Pharmaceuticals states that it will submit a New Drug Application for the Epidiolex drug with the FDA within the first six months of 2017. In the event the FDA approves Epidolex, the drug would become the first approved plant-derived cannabinoid drug in the United States. When the FDA approves an application for a new drug, the Drug Enforcement Administration will need to reschedule within three months. Therefore, if Epidiolex is approved by the FDA, the drug will be rescheduled. However, the DEA would not have to reschedule marijuana.

GW Pharmaceuticals has made it a point to emphasize that Epidiolex is not marijuana. As stated above, Epidiolex is an oral formulation derived from cannabidiol, which is one of the cannabinoids found in cannabis sativa. Cannabidiol is non-psychoactive cannabinoid in medical marijuana.

If the DEA chooses to declare Epidiolex a medicine, this could lead to a few complications. Since Epidiolex is a cannabinoid drug, it would be contradictory for the DEA to declare Epidiolex a medicine and then claim that marijuana has no benefits as a medicine. However, it is also contradictory for the U.S. government to have medical patents for marijuana and then claim that marijuana has no health benefits.

In the past year, stock for GW Pharmaceutical has gone up 26 percent. Recently, the stock has been trading for about $124. When there were rumors about the buyout potential for GW Pharmaceutical, the stock shot up. Chief medical officer Steven Wright recently sold more than 16,000 shares at about $100. He announced that the was planning to retire from the company in May 2017.

Undoubtedly, GW Pharmaceutical is posed to potentially make history. Not only will the approval of the Epidiolex drug make history, but it could also change the lives of those suffering from LGS for the better.

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