CBD Superior to Placebo, Similar to AEDs for Managing Epilepsy Syndromes

CBD Superior to Placebo, Similar to AEDs for Managing Epilepsy Syndromes

Cannabinoids (CBDs) demonstrated superior efficacy to placebo and similar efficacy to that of other antiepileptic drugs for managing Dravet syndrome and Lennox–Gastaut syndrome in pediatric patients as well as for adults with epilepsy, according to review results of 3 randomized trials published in Developmental Medicine & Child Neurology.

In 3 recently published trials, all of which began with a 4-week baseline period, a subsequent 2-week escalation phase, a 12-week maintenance, and a 14-week treatment period, researchers administered CBD at 20 mg/kg/day. Only 1 of the 3 trials had an additional arm of 10 mg/kg/day CBD. The first trial, comprised of pediatric patients with Dravet syndrome, found that 43% of patients who received CBD experienced a >50% reduction in convulsive seizures vs 27% of patients who received placebo. In addition, 5% of patients treated with CBD achieved seizure freedom.

A greater percentage of parents of patients who received CBD reported improvement on the Caregiver Global Impression of Change compared with parents of those who received placebo (57% to 58% vs 38% to 44%, respectively). In a double-blind, randomized trial of adults patients with epilepsy (age 18-70 years) who received CBD, no difference was found between CBD and placebo with regard to seizure reduction.

With regard to tetrahydrocannabinol for the management of pediatric epilepsy, the researchers added, “there are concerns about the effect of [tetrahydrocannabinol] on the developing brain with well documented earlier onset of psychosis in patients who take recreational [tetrahydrocannabinol].” The researchers added that there exist “a large number of other cannabinoids with fewer side effects as suggested by animal models, some of which are under investigation and may hold promise for treatment of epilepsy in the future.”

SOURCE: Neurology Advisor by B. May

Is CBD Oil Legal? State-By-State and Future Legality.

Is CBD Oil Legal? State-By-State and Future Legality.

CBD oil has exploded in popularity lately. Where is it legal, what are the exceptions and what is the future of its federal legality?

As the push for legal medical marijuana turned into one of the more universally popular stances in the country, advocates have been pushing for more states to legalize cannabis entirely.

While only 9 states currently have legalized recreational marijuana, as an industry weed has had a huge year of growth. This is in large part due to the increasing popularity of products that contain CBD in them. CBD, short for cannabidiol, is one of the hundreds of compounds found in the cannabis plant, and the potential it has shown in helping with pain, seizures and anxiety have made it a natural fit for medical and recreational weed alike.

The most commonly used form of CBD is CBD oil. Combining CBD extract with a carrier oil like coconut oil, it can be ingested or vaped, bringing a lot of variety. But because marijuana legalization is in such a murky situation with both federal and state laws to grapple with, CBD oil’s legality can be hard to parse depending on where you are. Let’s start with legality at the federal level.

Is CBD Oil Legal Federally?

Despite the many states that have legalized some or all forms of marijuana, federally the U.S. Drug Enforcement Administration (DEA) continues to classify CBD as a Schedule I drug. Schedule I drugs are defined by the DEA as “drugs with no currently accepted medical use and a high potential for abuse.” This is how not just CBD, but the entire cannabis plant is classified.

Of course, because legal marijuana is in such a confusing transitional period, even here there are potential exceptions. The U.S. Food and Drug Administration (FDA) approved Epidiolex, a treatment for a rare form of pediatric epilepsy that contains CBD. The DEA decided to classify this as a Schedule 5 drug, the scheduling that indicates the lowest potential for addiction and abuse.

Hemp producers who sell CBD products will often use the 2014 Farm Bill to claim that it is legal. This bill includes a provision that allows for the legal cultivation of hemp provided it is used for academic agricultural research or under a state pilot program. But there is still confusion about whether the legal allowance for cultivation also includes selling it.

The DEA hasn’t made going after CBD users a priority, but generally federally it remains illegal. You’ll have to go on a state-by-state level to see if CBD oil is legal where you are.

Which States Allow CBD Oil?

The push for legal cannabis has made enough progress that now there are only three states where marijuana of any sort in any form continues to be completely illegal. Those states are:

  • Idaho
  • Nebraska
  • South Dakota

If you don’t live in these states, you may be able to acquire legal CBD oil. But each state has its own specifics you need to be aware of.

States Where Marijuana Is Fully Legal

Currently, there are 10 states in America where marijuana is legalized both medically and recreationally. This does not count Washington D.C., which also has full legalization.

These 10 states with legal cannabis are:

  • Alaska
  • California
  • Colorado
  • Maine
  • Massachusetts
  • Michigan
  • Nevada
  • Oregon
  • Vermont
  • Washington

Michigan is the most recent state to legalize marijuana after state voters easily voted for the ballot initiative in the 2018 midterm elections.

In these states (and D.C.), simply go to a dispensary and you will be able to purchase CBD oil legally – provided you are 18 or over.

States Where Medical Marijuana Is Legal

In addition to the states with legal recreational weed, there are 23 other states where it is legal but only at a medical level. Those 23 states are:

  • Arizona
  • Arkansas
  • Connecticut
  • Delaware
  • Florida
  • Hawaii
  • Illinois
  • Louisiana
  • Maryland
  • Minnesota
  • Missouri
  • Montana
  • New Hampshire
  • New Jersey
  • New Mexico
  • New York
  • North Dakota
  • Ohio
  • Oklahoma
  • Pennsylvania
  • Rhode Island
  • Utah
  • West Virginia

The most recent of these states to legalize medical marijuana were Missouri and Utah, who like Michigan voted to pass it in the 2018 midterms. Oklahoma also voted to legalize medical marijuana earlier in 2018.

Whereas Michigan already had medical weed legalized to make for a quicker route to starting full legislation, these states don’t yet have an operational system in place. North Dakota and West Virginia also still are not operational yet, nor in Louisiana or Arkansas. Ohio is also behind schedule, having been unable to meet their goal of having operational dispensaries two years after voting for legalization. And until those are operational, the Ohio Board of Pharmacy ruled that any CBD products not sold in dispensaries licensed by the state’s program are illegal.

While in all of these states recreational marijuana remains illegal, Connecticut, Delaware, Illinois, Maryland, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New York, North Carolina, Ohio and Rhode Island have all decriminalized the drug. In these states, having smaller amounts of marijuana on you won’t lead to an arrest or a criminal record. The maximum amount you’re allowed to have on your person will vary by state.

In these states, you’ll need to talk with your doctor and see if you have an ailment that qualifies under state law for medical marijuana use, then get your medical marijuana card.

States Where Only CBD Oil Is Legal

That’s a whopping 33 states where, operational or otherwise, some form of marijuana is now legal. Add those up with the 3 states where it is completely illegal, and you’re left with 13 states.

The laws in these 14 states can vary widely, but to differing degrees, medical cannabidiol can be allowed for legal use there. Many of these states have very strict rules for who can and cannot get approved for CBD based on what medical condition they have the severity of it.

Here are the 14 states with some form of legal medical CBD and what the requirements are, per the National Organization for the Reform of Marijuana Laws (NORML):

  • In Alabama, the only access to legal CBD is either by being part of a state-sponsored clinical trial, or having a debilitating medical condition for which they are currently under treatment. The access via debilitating medical conditions is also known as Leni’s Law.
  • In Georgia, CBD oil can legally be prescribed to patients with over a dozen medical conditions, including cancer, multiple sclerosis, Parkinson’s disease and seizure disorders. The legal limit a patient can have is 20 ounces of marijuana oil with no more than 5% THC, and the CBD amount must be equal to or greater than the THC.
  • Earlier in 2018, Indiana passed a law that made it legal to manufacture, sell in retail, possess and use CBD oil provided it had no more than 0.3% THC content in it. This was a major expansion of the legality of CBD, no longer requiring Indiana citizens to be on a patient registry to buy CBD oil.
  • The Department of Public Health in Iowa allows for limited amounts of CBD oil for patients suffering from several medical conditions. This includes HIV/AIDS, cancer, ALS and seizures. Five dispensaries opened very recently in Iowa. This oil can be found in creams, capsules and more.
  • In 2018, Kansas passed a law that exempted CBD products from the state’s criminal code regarding marijuana. This allows for adults to legally purchase and possess CBD products as long as they contain 0% THC.
  • Kentucky has laws that allow for state-sponsored cultivation of hemp, which can be used to make CBD oil.
  • Mississippi made it legal for patients with severe epilepsy to use products high in CBD as long as they were low in THC in 2014. The cannabis extract must have more than 15% CBD, but no more than 0.5% THC, and must be done by or under the supervision of a licensed physician.
  • The law in North Carolina also only makes CBD legal for patients with intractable epilepsy. The CBD for this is made from hemp extract.
  • South Carolina legalized CBD for those suffering from severe epilepsy disorders (including Dravet Syndrome, the condition Epidiolex was created to treat). The cannabis extract for must have extremely trace amounts of THC.
  • The state of Tennessee considers CBD made from hemp extract, not marijuana, to be legal. CBD is also able to be prescribed to patients with intractable epilepsy if it contains trace amounts (no more than nine-tenths of one percent) of THC
  • The CBD law in Texas also makes an exception for intractable epilepsy patients. This went into law in 2015, and the extract must contain over 10% CBD and no more than 0.5% THC.
  • Virginia recently expanded legal CBD use when Governor Ralph Northram signed into law a bill that legalized CBD oil for any condition diagnosed by a licensed doctor or practitioner.
  • CBD has been legal as a treatment for seizure disorders in Wisconsin since 2014, and in 2017 the Senate expanded its legality to be used as treatment for any medical condition a doctor recommended it for.
  • Wyoming has a particularly narrow law for CBD oil. It is only legal for patients with epilepsy that has not responded to other treatments. Neurologists have to give the state’s Department of Health a statement about how the patient needs and would benefit from the CBD, made from hemp extract, and then the patient may be able to receive a card that allows them to receive cannabis with high concentrations of CBD and trace amounts of THC.

What Would the 2018 Farm Bill Do for CBD Legality?

In 2018, the Senate introduced a new Farm Bill to update laws around the previous one. One important part of that bill, should it pass, is that it would legalize hemp on a federal level.

Hemp being federally legal would be huge for the CBD industry, as CBD oil made from hemp extract (a plant that has very low amounts of THC) would be legal. A new, more available form of CBD would also allow for more research on the subject of cannabidiol, and perhaps the entire marijuana plant. More research brings the potential of coming closer to full legalization.

SOURCE: TheStreet.com

Benefits of CBD for Epilepsy Faded in One-Third of Patients

Benefits of CBD for Epilepsy Faded in One-Third of Patients

About one-third of patients who used cannabidiol (CBD) to manage treatment-resistant epilepsy developed tolerance to it, researchers from Israel reported here.

In a study of 92 children and young adults with treatment-resistant seizures who used cannabis oil extract for an average of 19.8 months, tolerance to CBD emerged in 32.6% of patients, reported Shimrit Uliel-Sibony, MD, of Tel Aviv Sourasky Medical Center’s Dana Children’s Hospital, and colleagues at the American Epilepsy Society annual meeting.

In the U.S., the FDA has approved a purified, pharmaceutical-grade formulation of cannabidiol (Epidiolex), a chemical component of the Cannabis sativa plant, for children with Lennox-Gastaut and Dravet syndromes.

In this prospective study, Uliel-Sibony and colleagues followed patients in Tel Aviv, ages 1-37 years (average age 11.8) from 2014 to 2017 with treatment-resistant epilepsy of various etiologies, ranging from Dravet syndrome and Lennox-Gastaut syndrome to epilepsy caused by stroke. All patients subsequently had been treated with one of two strains of CBD-enriched cannabis oil extract that had a 20:1 CBD-to-tetrahydrocannabinol (THC) ratio.

The researchers defined tolerance as either the necessity to increase dose by ≥30% after efficacy declined, or a response reduction of >30%. They saw tolerance in 30 patients, on an average dose of 12.6 mg/kg/day. The mean time until tolerance appeared was 7.3 months (range 1-24 months).

The researchers increased the CBD dose in most patients who developed tolerance; 12 patients achieved their previous response level and 15 did not.

“This study found that tolerance develops in one-third of patients with treatment-resistant epilepsies who showed an initial reduction in seizures to a high CBD/low THC product after 7 months,” Devinsky told MedPage Today. “The observation that two-thirds of patients did benefit over a long follow-up period is a key finding.”

There was no statistically significant correlation between patient’s age and tolerance, but patients with shorter epilepsy duration showed a higher tendency to develop tolerance, Uliel-Sibony’s group noted. Predictive factors and mechanisms are unknown, and long-term studies to better characterize the long-term efficacy and safety of CBD are needed, they added.

SOURCE: MedPageToday.com by J. George with Primary Source American Epilepsy Society

 

Source Reference: Uliel-Sibony S, et al “Cannabidiol tolerance in children and adults with treatment-resistant epilepsy” AES 2018; Abstract 2.233.

Today Is a Historic Day – DEA Schedules First FDA Marijuania Based Medication

Today Is a Historic Day – DEA Schedules First FDA Marijuania Based Medication

Thursday, September 27 marks a historic day. Today the DEA (United States Drug Enforcement Administration) scheduled the first marijuana based medication.

Epidiolex(r) is a FDA approved medication that is made up of highly-purified, plant-derived cannabidiol (CBD) in a proprietary oral solution of pure plant-derived cannabidiol or CBD and was scheduled today at a “V”.  Epidiolex(R) will be used for, early-onset, treatment-resistant epilepsy syndromes including Dravet syndrome, Lennox-Gastaut syndrome (LGS) and Tuberous Sclerosis Complex (TSC). The release of the drug will mark the first time that such a prescription drug has been made available to the U.S. public and now is available for sale in the U.S.  The company needs to finalize the product label for the drug and expects to have it ready for customers in six weeks. Greenwich Biosciences, GWPH’s U.S. subsidiary, will be marketing the drug in America.

This scheduling is historic in that level V is reserved for drugs, substances, or chemicals defined as drugs with lower potential for abuse than other schedules. Example: Schedule V drugs are generally used for antidiarrheal, antitussive, and analgesic purposes. Some examples of Schedule V drugs are cough preparations with less than 200 milligrams of codeine or per 100 milliliters (Robitussin AC), Lomotil, Motofen, Lyrica, Parepectolin.

We also hope this will open the door on how marajuania is schedule. Currently it is a “Level I”, consistent with heroin and other addictive drugs. This scheduling has made it very restrictive to nearly impossible to gain access to it for valid medical research. Example, Epidiolex(r) was developed in the UK prior to U.S. FDA approved medical trials.

For more on understanding scheduling read on.

What is Drug Scheduling

Drug Schedules

Drugs, substances, and certain chemicals used to make drugs are classified into five (5) distinct categories or schedules depending upon the drug’s acceptable medical use and the drug’s abuse or dependency potential. The abuse rate is a determinate factor in the scheduling of the drug; for example, Schedule I drugs have a high potential for abuse and the potential to create severe psychological and/or physical dependence. As the drug schedule changes– Schedule II, Schedule III, etc., so does the abuse potential– Schedule V drugs represents the least potential for abuse. A Listing of drugs and their schedule are located at Controlled Substance Act (CSA) Scheduling or CSA Scheduling by Alphabetical Order. These lists describes the basic or parent chemical and do not necessarily describe the salts, isomers and salts of isomers, esters, ethers and derivatives which may also be classified as controlled substances. These lists are intended as general references and are not comprehensive listings of all controlled substances.

Please note that a substance need not be listed as a controlled substance to be treated as a Schedule I substance for criminal prosecution. A controlled substance analogue is a substance which is intended for human consumption and is structurally or pharmacologically substantially similar to or is represented as being similar to a Schedule I or Schedule II substance and is not an approved medication in the United States. (See 21 U.S.C. §802(32)(A) for the definition of a controlled substance analogue and 21 U.S.C. §813 for the schedule.)

Schedule I

Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse. Some examples of Schedule I drugs are:

heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), 3,4-methylenedioxymethamphetamine (ecstasy), methaqualone, and peyote

Schedule II

Schedule II drugs, substances, or chemicals are defined as drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence. These drugs are also considered dangerous. Some examples of Schedule II drugs are:

Combination products with less than 15 milligrams of hydrocodone per dosage unit (Vicodin), cocaine, methamphetamine, methadone, hydromorphone (Dilaudid), meperidine (Demerol), oxycodone (OxyContin), fentanyl, Dexedrine, Adderall, and Ritalin

Schedule III

Schedule III drugs, substances, or chemicals are defined as drugs with a moderate to low potential for physical and psychological dependence. Schedule III drugs abuse potential is less than Schedule I and Schedule II drugs but more than Schedule IV. Some examples of Schedule III drugs are:

Products containing less than 90 milligrams of codeine per dosage unit (Tylenol with codeine), ketamine, anabolic steroids, testosterone

Schedule IV

Schedule IV drugs, substances, or chemicals are defined as drugs with a low potential for abuse and low risk of dependence. Some examples of Schedule IV drugs are:

Xanax, Soma, Darvon, Darvocet, Valium, Ativan, Talwin, Ambien, Tramadol

Schedule V

Schedule V drugs, substances, or chemicals are defined as drugs with lower potential for abuse than Schedule IV and consist of preparations containing limited quantities of certain narcotics. Schedule V drugs are generally used for antidiarrheal, antitussive, and analgesic purposes. Some examples of Schedule V drugs are:

cough preparations with less than 200 milligrams of codeine or per 100 milliliters (Robitussin AC), Lomotil, Motofen, Lyrica, Parepectolin

Cannabis 101: A guide to CBD oil

Cannabis 101: A guide to CBD oil

Cannabidiol, or CBD, is a non-intoxicating chemical compound that comes from the cannabis sativa plant.  CBD is one of over 100 such compounds, known as cannabinoids, which are found in the plant.

Unlike THC — or tetrahydrocannabinol, another cannabinoid — CBD is non-euphoric.

What is the history of CBD?

CBD was first discovered in the 1940’s by Roger Adams, the former head of the chemistry department at University of Illinois at Champaign-Urbana. In his research, Adams isolated CBD from hemp but couldn’t determine what exactly he’d found. In addition to CBD, Adams also synthesized analogs of THC and another cannabinoid, showing their relationship to CBD.

In the 1960’s, Israeli chemist Raphael Mechoulam and his team took the research further, eventually synthesizing cannabinoids — including CBD, THC and others — and describing their chemical structures for future research. Mechoulam, a professor at Hebrew University of Jerusalem, still studies cannabis to this day.

Is CBD legal?

Much confusion exist around CBD due to current murky legal status.

The Federal DEA still list hemp and marijuana as dangerous Schedule I drugs, along with heroin and ecstasy, CBD remains illegal under federal law. Congress is now is considering the 2018 Farm Bill, which would legalize industrial hemp across the country.

Despite some confusion, the Agriculture Act of 2014 didn’t legalize hemp-based CBD products nationwide, but only allowed for states and universities to grow hemp. Nevertheless, hemp-based CBD is already widely and freely available throughout most of the country.

At this time, 37 states that have legalized marijuana-based CBD for medical use, while nine other states have fully legalized marijuana and its derivatives. Four other states — Idaho, Kansas, Nebraska and South Dakota still prohibit the medical use of marijuana-based CBD.

What is CBD used to treat?

In a study released last year, the World Health Organization’s Expert Committee on Drug Dependence said CBD may benefit people diagnosed with:

  • Alzheimer’s disease
  • Parkinson’s disease
  • Multiple sclerosis
  • Huntington’s disease
  • Pain
  • Psychosis
  • Anxiety
  • Depression
  • Cancer
  • Nausea
  • Inflammatory diseases
  • Rheumatoid arthritis
  • Infection
  • Inflammatory bowel and Crohn’s disease
  • Cardiovascular diseases
  • Diabetic complications

In the report, the committee noted that “CBD exhibits no effects indicative of any abuse or dependence potential.” Other health care professionals are also using CBD to treat other medical issues, like autism, sleep problems and other mental health conditions.

CBD started gaining national exposure when media outlets began profiling Charlotte Figi, an 11-year-old girl from Colorado with Dravet syndrome, a severe form of intractable epilepsy.

At age 5, Figi’s parents, Matt and Paige Figi, had exhausted all traditional options in their quest to control the hundreds of grand mal seizures their young daughter was experiencing every day. They ultimately turned to the Stanleys, a group of brothers who grow marijuana in Colorado, who then developed a groundbreaking CBD oil they called “Charlotte’s Web.”

Since she began taking the oil, Charlotte has experienced far fewer seizures and is able to enjoy a more normal childhood. However, evidence from cases like Figi’s remains largely anecdotal as researchers continue to pin down CBD’s exact scientific effects.

What are the effects of CBD?

Unlike THC, CBD doesn’t get users high, an important distinction that has helped drive the popularity of the drug compound.

Traditional medications tend to target the symptoms of a specific condition, but CBD goes after the cause of those symptoms, according to Ronald Aung-Din, M.D., a renowned Florida neurologist.

Pharmaceuticals generally stimulate or block receptors to provide their function, but CBD and other cannabis-based treatments interact with the body’s endocannabinoid system, which naturally binds to chemicals like CBD and THC. This biological effect reportedly enables CBD to treat such a wide range of medical conditions.

A European study published last year by the National Center for Biotechnical Information listed tiredness, diarrhea and changes in weight and appetite as possible side effects of CBD. Most of the research was conducted on patients with epilepsy or psychotic disorders.

Are there different types of CBD?

Yes, there are several different types including:

Marijuana-based CBD:

CBD products that come from the marijuana plant tend to have higher amounts of THC, a combination that some experts claim increases the CBD’s healing effects. As a result, CBD strains with higher amounts of THC can cause both euphoria and stony side effects, like anxiety, paranoia and dizziness.

Hemp-Based CBD:

Hemp-based CBD products can be bought over-the-counter (OTC) in many states and some internet sales.  A trend lately in some states is to “confiscate” over the counter/internet CBD due to the lack of control on content, quality, contaminants, etc.

Some OTC product may contain a full range of hundreds of cannabinoids, including cannabinol (CBN), cannabigerol (CBG) and tetrahydrocannabivarin (THCV), as well as CBD and a minuscule amount of THC.

All the different chemicals found in the cannabis plant are said to have various healing effects. For example, non-intoxicating CDG apparently helps with sleep and inflammation and kills bacteria.

Pharmaceutical CBD:

In June, the U.S. Food and Drug Administration approved the first prescription CBD drug, a move that will almost undoubtedly spur more research into what else it can treat.

The drug, a strawberry-flavored syrup called Epidiolex, is used to treat two rare forms of childhood epilepsy. During their research, FDA officials found that Epidiolex reduced seizures when it was combined with other epilepsy drugs.

FDA Commissioner Scott Gottlieb said his agency had supported research on cannabis-derived products for “many years,” but warned against the use of CBD products with “unproven medical claims.”

“The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases,” Gottlieb said.

Before Epidiolex can go to market, the Drug Enforcement Administration must formally reclassify CBD into a federal drug category with medical approval. The FDA has previously approved synthetic cannabinoids to treat severe weight loss in patients with HIV.

Source: Most of the content from an article by T. Schuba for the Chicago Sun Times

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