Breaking News
September 20, 2018 - Investigators find that bile acids reduce cocaine reward
September 20, 2018 - Cannabinoid drugs reduce perceived unpleasantness of painful stimuli and increase tolerance
September 20, 2018 - Geroscience takes center stage in Journal of the American Medical Association
September 20, 2018 - Ambient Particulate Matter Linked to Emergency Asthma Care
September 20, 2018 - Patient satisfaction with plastic surgery—it’s the surgeon, not the practice
September 20, 2018 - Medicine is a team sport – and that’s exactly how it should be
September 20, 2018 - Logos Biosystems releases new electrophoretic tissue clearing system with twice the features in half the space
September 20, 2018 - Novel micro-platform reveals never-before-seen behaviors of cancer cells
September 20, 2018 - PAREXEL partners with Datavant to enhance clinical study design and generate real-world evidence
September 20, 2018 - Robert Koch Institute publishes new data on allergies, mental health problems, and accident injuries
September 20, 2018 - Study finds higher readmission rates in for-profit hospitals
September 20, 2018 - Encouraging youth to do strength-based exercises could help tackle child obesity
September 20, 2018 - Sleep apnea, congenital heart disease in hospitalized infants strongly associated with death
September 20, 2018 - Researchers find way to map mysterious content of non-coding RNA
September 20, 2018 - Air Pollutants Reach Placenta, Might Harm Fetus: Study
September 20, 2018 - Sleep apnea, congenital heart disease may be deadly mix for hospitalized infants
September 20, 2018 - My relative has cancer, should I worry? Encouraging cascade genetic testing
September 20, 2018 - Investigators determine specific treatable traits that can predict future asthma attacks
September 20, 2018 - More doctor visits can lower risk of suicide attempts in fibromyalgia patients
September 20, 2018 - Computer avatars play role in diagnosis of dementia
September 20, 2018 - Addition of CTLA4 targeted therapy to PD-1 targeted therapy may benefit patients with ovarian cancer
September 20, 2018 - ASPREE trial explores whether low dose aspirin can prolong good health in elderly people
September 20, 2018 - ATS publishes new guideline focused on weight loss strategies for sleep apnea patients
September 20, 2018 - The Current issue of “The view from here” is concerned with Drug Delivery
September 19, 2018 - Sleep apnea could favour tumor growth at young ages
September 19, 2018 - Stealth vaping fad hidden from parents, teachers
September 19, 2018 - Witnessing school violence linked to later risk of psycho-social and academic impairment
September 19, 2018 - Common household cleaners could make children overweight by changing gut microbiota
September 19, 2018 - Salk research in yeast leads to serendipitous finding about hypomyelinating leukodystrophy
September 19, 2018 - Study: Overweight or obese women may have increased risk of urinary incontinence
September 19, 2018 - Study shows how cellular waste disposal processes also promote inflammation
September 19, 2018 - New multidisciplinary microsurgery microscope, PROVIDO, introduced by Leica
September 19, 2018 - Phase 2b STORM Data Evaluating Selinexor in Patients with Penta-Refractory Multiple Myeloma Presented at the Society of Hematologic Oncology 2018 Annual Meeting
September 19, 2018 - Decisions recruiting gut feelings seen as reflection of true self, more assuredly held, study says
September 19, 2018 - How AI can improve end-of-life care
September 19, 2018 - UNIST and Ulsan initiate research collaboration to develop human organs-on-chips
September 19, 2018 - Study highlights key role of migrating shoals of fish in sustaining deep-ocean microorganisms
September 19, 2018 - Disagreeable individuals can benefit most from behaving more compassionately, finds study
September 19, 2018 - Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Erdafitinib for the Treatment of Metastatic Urothelial Cancer
September 19, 2018 - Neuroplasticity is increased but dysregulated in the aging brain, study finds
September 19, 2018 - Suicide: A public health crisis
September 19, 2018 - Infants using popular anti-reflux medicines are not at increased risk of lung infections
September 19, 2018 - Stanford team will participate in NIH-funded study of tobacco policies | News Center
September 19, 2018 - Women with high levels of anti-Müllerian hormone more likely to develop breast cancer
September 19, 2018 - Researchers use larval zebrafish model to reveal role of locus coeruleus in anesthesia
September 19, 2018 - Effects of prematurity found to be more severe for the brains of males than females
September 19, 2018 - NIH funds CWRU to investigate new imaging approach for diagnosing peripheral arterial disease
September 19, 2018 - NUS researchers develop new device for quick and accurate screening of diseases
September 19, 2018 - Leading nutritionist explains about different types of iron in oral supplements
September 19, 2018 - New Crest Gum & Enamel Repair toothpaste may boost enamel repair and reverse gingivitis
September 19, 2018 - Analysis does not find any safety concerns of bivalent HPV vaccine
September 19, 2018 - Many Older Adults Transition to Long-Term Benzodiazepine Use
September 19, 2018 - Caregiving – resources – older adults: MedlinePlus Medical Encyclopedia
September 19, 2018 - Research shows that cystic fibrosis impacts growth in the womb
September 19, 2018 - Study shows how head, neck positioning affects concussion risk | News Center
September 19, 2018 - Antioxidant in green tea helps sneak therapeutic RNAs into cells
September 19, 2018 - Excess pregnancy weight gain affects cardiometabolic risk in offspring
September 19, 2018 - Penn researchers find common thread linking almost all TNR expansion diseases
September 19, 2018 - Ipsen receives approval from Health Canada for CABOMETYX tablets for treating renal cell carcinoma
September 19, 2018 - Researchers use CRISPR screen to reveal new targets in squamous cell carcinomas
September 19, 2018 - UGR to coordinate the European H2020 project focused on Smart Personalized Nutrition
September 19, 2018 - Mumps Spread Quickly at Texas Cheerleading Meets: Study
September 19, 2018 - Addressing child stunting in Pakistan is critical
September 19, 2018 - Innovative system makes hospitals, clinics accessible for people with visual impairments
September 19, 2018 - CXCL14 protein is secreted by brown adipose tissue and has beneficial effects in metabolic diseases
September 19, 2018 - Air pollution increases risk of dementia
September 19, 2018 - Inequality issues persist even under new U.S. kidney transplant allocation system
September 19, 2018 - New study reveals mechanisms that lead to cognitive decline in Type 2 diabetes
September 19, 2018 - FDA launches new comprehensive effort to educate kids about dangers of e-cigarettes
September 19, 2018 - Study reveals mechanism underlying plants’ ability to signal defense
September 19, 2018 - Researchers harness Zika virus vaccine under development to target glioblastoma
September 19, 2018 - Novel deep learning drug discovery platform gets £1 million innovation boost
September 19, 2018 - Sensor array may detect de novo Parkinson’s disease in breath
September 19, 2018 - A roadmap for the future of electronic health records
September 19, 2018 - Surprising research showing peptide adaptability may pave way to develop immunotherapies
September 19, 2018 - Amyloid β protein makes comeback as therapeutic target for Alzheimer’s disease
September 19, 2018 - Alcon expands its global support of eye care professionals through Alcon Experience Academy
September 19, 2018 - Study gives new insights into how cells leverage GPCRs to control inflammation
September 19, 2018 - Automatic relevance detection in ophthalmic surgery videos
September 19, 2018 - UNIST to accelerate discovery, development of new medicines for incurable diseases
Approval of drug derived from cannabis not necessarily a win for weed

Approval of drug derived from cannabis not necessarily a win for weed

image_pdfDownload PDFimage_print
Approval of drug derived from cannabis not necessarily a win for weed
Small vials of CBD, an ingredient in a drug just approved by the FDA to treat two types of epilepsy. Credit: Roxana Gonzalez/Shutterstock.com

The Food and Drug Administration on June 25 approved for the first time a drug made from cannabidiol (CBD), a molecule derived from the cannabis plant. The drug, Epidiolex, was approved for the treatment of two types of epilepsy, Dravet syndrome and Lennox-Gastaut syndrome, that have been resistant to treatment.

Well-designed clinical trials have shown that the Epidiolex product of CBD can be helpful in reducing or eliminating seizures in these epilepsy syndromes.

While medical marijuana supporters may cite the FDA approval of Epidiolex as evidence of the benefits of marijuana, it is not an endorsement of any CBD or cannabis product. This product differs from most other CBD products available in cannabis dispensaries in that it is a highly concentrated and purified pharmaceutical grade medicine. It is the only CBD product to receive FDA approval, at this time. Other pharmaceutical grade products may be developed and approved in the future. Additionally, this product could be approved by the FDA for other types of epilepsy or diseases.

The next step in the process of making this CBD product available is rescheduling by the Drug Enforcement Agency. Currently, CBD is a Schedule I drug, meaning that it has abuse potential and no proven medical use. As a Schedule I drug, CBD use is greatly restricted and controlled. Now that the FDA has approved a medical use, the DEA has 90 days to reschedule the drug, making it available for medical uses.

It is unclear at this time what the DEA will determine as an appropriate schedule for CBD. Once the DEA has rescheduled CBD, the Epidiolex product will be available for physicians to prescribe. While the current FDA approval of this CBD product is for two specific epilepsy syndromes, the FDA does not restrict its use only to epilepsy. Physicians will be able to legally prescribe this product for any use when they believe there is sufficient scientific evidence.

As a professor of pharmacy with a special interest in epilepsy, I find it important that CBD may be a new option for the treatment of epilepsy. This new use has led me to carefully study published literature on CBD and discuss it as an option with patients who have epilepsy. Additionally, I have been involved with the American Epilepsy Society’s ongoing review of CBD as a possible treatment for epilepsy. From this perspective, I believe that CBD may offer benefits for patients with some types of epilepsy and possibly other disorders.

No high, but healing?

The cannabis plant produces hundreds of different compounds, many of which have differing effects in the body. Tetrahydrocannabinol, or THC, is the substance that is most known for its psychoactive effects, or the “high” associated with marijuana.

However, there are many other substances from the cannabis plant that also produce effects in the body. Many of these differ from THC in that they are not psychoactive – and they do not produce a “high.” Cannabidiol, or CBD, is one of those substances.

Cannabidiol is a complex molecule that is produced by the cannabis plant. Cannabis has been proposed for centuries as a medicinal plant. Only recently has CBD been studied scientifically for various disorders.

Compared to THC, CBD works at different receptors in the brain and other parts of the body. In this way, CBD is very different from THC and may offer new mechanisms of treatment. For this reason, CBD has received a great amount of attention as a possible treatment for many different disorders.

CBD has been proposed as a cure or treatment for many disorders and diseases, including epilepsy, chronic pain, anxiety, multiple sclerosis, amyotropic lateral sclerosis (ALS or Lou Gehrig’s disease) and insomnia. Some of these uses are based on science, but others are proposed by advocates of CBD and medical marijuana. Several anecdotal reports, case reports, case series and small studies have reported on CBD for many of these disorders. Information from these reports is conflicting. Case reports, case series and small studies are considered insufficient evidence to prove or disprove the safety and efficacy of a drug or treatment. This is because these studies are usually unable to distinguish between the effect of a drug and a placebo effect, the patient thinking the drug is working when it really is not providing benefit.

However, there are two well-designed, large studies that indicate CBD is effective in the two different epilepsy syndromes. In these studies, about 40 percent of patients taking CBD had a significant reduction in specific types of seizures.

Epilepsy is the only disorder where there is solid scientific evidence demonstrating that CBD is safe and effective. This does not mean that CBD will not work for other disorders, but epilepsy is the only one where we have clear, well-documented evidence that CBD helps.

Results from these studies show that CBD does have side effects. The most common ones are drowsiness, nausea, intestinal cramping, bloating and diarrhea. More serious side effects can occur. In one of the studies in epilepsy, about 10 percent of patients taking CBD had an increase in laboratory tests of liver function. These tests commonly indicate damage to the liver. About 2-3 percent of patients taking CBD had to discontinue it due to large increases in certain liver enzymes in laboratory tests, showing possible liver damage.

We are also learning about drug interactions that occur with CBD. In these studies, CBD slowed the metabolism of several drugs that are commonly given to individuals with epilepsy. The interactions between CBD and other drugs patients were taking caused side effects. It is unclear if these side effects were due to CBD, the other drugs, or a combination. Doses of the other drugs were reduced, due to the interactions.

The mechanism for these interactions indicate that there are likely several other interactions between CBD and other common medications. Cannabidiol needs to be used cautiously in combination with other medications.

Issues beyond effectiveness

There are several other factors to consider in regards to CBD. Cannabidiol does not dissolve well in water. For this reason, oral products of CBD are made with an oil, often some type of vegetable oil. It is important that the right oil is used.

Also, less than 20 percent of an oral dose of CBD is absorbed. This makes it difficult to produce a CBD product where CBD is reliably and consistently absorbed.

An FDA study of unregulated CBD products available on the market shows these products are frequently contaminated with things like pesticides, herbicides, fungus or bacteria. Additionally, the FDA found that over 50 percent of CBD products may not contain the amount of CBD on the label. This is especially true in states where CBD products are not regulated by the state. In 17 states where there is regulation, there is much better control on product quality and purity.

Finally, there are two pharmaceutical-grade CBD products that have been studied for production by a pharmaceutical company. One is Epidiolex, and the other is still being studied.

So far, the evidence is that CBD is safe and effective for specific epilepsy syndromes. There is insufficient scientific evidence to indicate whether it is effective or ineffective for other disorders. Information from well-designed studies do indicate that CBD causes important side effects and drug interactions that must be considered. Individuals who wish to use CBD should be managed and monitored by health care professionals familiar with its use.


Explore further:
Why marijuana fans should not see approval for epilepsy drug as a win for weed

Provided by:
The Conversation

Tagged with:

About author

Related Articles