FDA advisers recommend first CBD oil product

Federal advisers voted Thursday to recommend approval of the first cannabidiol medicine — to treat rare and severe forms of epilepsy.

The advisory committee to the Food and Drug Administration unanimously voted to recommend approval of the drug, which would be sold under the brand name Epidiolex.

Cannabidiol — CBD for short — is a cannabis derivative and the approval would be limited to treating seizures caused by Lennox-Gastaut syndrome (LGS) and Dravet syndrome in patients aged 2 and older.

"Epidiolex represents hope for the many individuals living with intractable seizures and rare epilepsies, who every day face incredible challenges and disabling seizures, and live with the continual risk of serious injury and death," said Philip Gattone, president and CEO of the Epilepsy Foundation.

RELATED: The health benefits of marijuana: 

8 PHOTOS
Health benefits of marijuana
See Gallery
Health benefits of marijuana

1. Parkinson's 

Cannabis has been found to help slow tremors and pain in Parkinson's patients. According to Medical News Today, the compounds in marijuana help to "reduce the effects of reduced dopamine in the brain". 

A study conducted by Israeli scientists found smoking marijuana helped reduce these tremors. "We not only saw improvement in tremor in these patients, but also in rigidity and in bradykinesia," said researcher Ruth Djaldetti.

Furthermore, marijuana has been found to slow the progression of Parkinson's because of its antioxidant qualities. 

2. Glaucoma 

The American Academy of Ophthalmology describes glaucoma as a condition in which the optic nerve is damaged over long periods of time. It can limit vision and sometimes lead to blindness. 

The link between glaucoma and marijuana has been studied since the 1970s, as smoking marijuana has been found to lower eye pressure. Doctors are working on ways to elongate the effects of marijuana. 

It has been speculated that smoking the drug can slow the progression of the disease. 

3. Chemo patients

There has been extensive research on the benefits of cannabis and chemotherapy patients. The "wonder drug", as it is hailed, does miracles for cancer patients. 

According to Dr. Donald Abrams, marijuana "is the only anti-nausea medicine that increases appetite.”

The American Cancer Society claims that the drug can also lower pain, reduce inflammation and calm anxieties of not just chemo patients, but patients suffering from a chronic illness or disease. 

Scientists have found that cannabinoids, one of the many chemical compounds found in the plant, can inhibit tumor growth. It was particularly effective in the inhibition of colon cancer. 

4. Alzheimer's

According to an article published by CNN Health, marijuana may be beneficial for Alzheimer's patients. It was found that THC, an ingredient in cannabis, blocks inflammation in the brain and "stimulates the removal of toxic plaque". 

Marijuana has also been used to help dementia patients. Author and doctor David Casarett told CNN, "I spoke to many family members of people with mild or moderate dementia who believed that THC or whole-plant marijuana was effective in alleviating the confusion and agitation that sometimes occurs."

5. Skin Diseases 

It is widely known that marijuana possesses antiinflammatory benefits, helpful to patients who suffer from arthritis and cancer, amongst many others.

A study published by the University of Colorado found that using the drug topically can alleviate pain and "may be effective against eczema, psoriasis, atopic and contact dermatitis. More and more dermatologists are encouraging the use of cannabinoid cream. 

6. Stroke victims 

Cannabis and stroke victims is an interesting topic of study for many researchers, some of whom contend the drug can "shrink" the damaged area of the brain. 

Doctors, who tested the drug on mice, rats and monkeys, believe the chemical "shows promise as a neuroprotective treatment for stroke”, according to the Huffington Post.

7. PTSD

Advocates have argued that marijuana can provide immense relief for patients, specifically veterans, who suffer from PTSD. In states like New Mexico, "medical marijuana is legally prescribed for PTSD". 

A study conducted by the University of Haifa fond that marijuana helped block the "development" and progression of PTSD in rats. But, researchers explain, that there is a critical window of what marijuana can do. 

Interior of room at the clinic
HIDE CAPTION
SHOW CAPTION
of
SEE ALL
BACK TO SLIDE

The internet is awash in CBD products. It's being sold as a sleep aid and cancer cure, pain medicine and anxiety reliever. Most of the claims are unsubstantiated by careful medical studies and have become so blatant that the FDA has issued warnings to companies that make them.

This product is different.

A British company, GW Pharmaceuticals, has gone through the testing necessary to be considered for FDA approval.

Its carefully formulated product will have to be made under guidelines, called good manufacturing practices, so that buyers can count on getting what is supposed to be in the bottle.

Image: Medical Marijuana

The FDA has indicated that it would approve the drug. Although doctors may prescribe any FDA approved product as they see fit, the recommended use for this particular product is very limited.

"Both by Lennox-Gastaut syndrome and Dravet syndrome are rare, severe, refractory epilepsy syndromes with onset in early childhood," the FDA said.

It's not clear how or why CBD works, but studies show it does, the FDA said.

 

"The results from these three studies provide substantial evidence of the effectiveness of CBD for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome (LGS and DS)," the FDA said in briefing documents given to the advisory committee ahead of Thursday's meeting.

"In general, the risks associated with CBD treatment appear acceptable, particularly given the findings of clinical efficacy in LGS and DS, which are serious, debilitating, and life-threatening disorders."

Dravet syndrome is a very rare and often deadly form of epilepsy caused by a genetic mutation. These kids have multiple, prolonged seizures that cause brain damage. Lennox-Gastaut syndrome is also rare, causes various types of seizures and can also cause severe cognitive impairment.

There's no treatment for either.

 

Doctors are interested in also trying CBD to treat autism, anxiety, inflammatory and autoimmune disorders.

It's different from medical marijuana, because it does not contain THC, the compound that causes the most notable effects of marijuana used recreationally.

Medical marijuana is legal in 29 states, as well as in Guam and Puerto Rico. Studies have shown that it can have some benefits in reducing anxiety, counteracting some types of nausea, and that it may relieve some symptoms of glaucoma and multiple sclerosis.

And the FDA has approved several marijuana-based products, including the synthetic formulation Marinol, prescribed to treat severe appetite loss and nausea in conditions such as AIDS.

Read Full Story