Cannabidiol in Humans-The Quest for Therapeutic Targets.

“Cannabidiol (CBD), a major phytocannabinoid constituent of cannabis, is attracting growing attention in medicine for its anxiolytic, antipsychotic, antiemetic and anti-inflammatory properties.

However, up to this point, a comprehensive literature review of the effects of CBD in humans is lacking. The aim of the present systematic review is to examine the randomized and crossover studies that administered CBD to healthy controls and to clinical patients.

A systematic search was performed in the electronic databases PubMed and EMBASE using the key word “cannabidiol”. Both monotherapy and combination studies (e.g., CBD + ∆9-THC) were included. A total of 34 studies were identified: 16 of these were experimental studies, conducted in healthy subjects, and 18 were conducted in clinical populations, including multiple sclerosis (six studies), schizophrenia and bipolar mania (four studies), social anxiety disorder (two studies), neuropathic and cancer pain (two studies), cancer anorexia (one study), Huntington’s disease (one study), insomnia (one study), and epilepsy (one study).

Experimental studies indicate that a high-dose of inhaled/intravenous CBD is required to inhibit the effects of a lower dose of ∆9-THC. Moreover, some experimental and clinical studies suggest that oral/oromucosal CBD may prolong and/or intensify ∆9-THC-induced effects, whereas others suggest that it may inhibit ∆9-THC-induced effects.

Finally, preliminary clinical trials suggest that high-dose oral CBD  may exert a therapeutic effect for social anxiety disorder, insomnia and epilepsy, but also that it may cause mental sedation. Potential pharmacokinetic and pharmacodynamic explanations for these results are discussed.”

http://www.ncbi.nlm.nih.gov/pubmed/24281562

Cannabidivarin (CBDV) suppresses pentylenetetrazole (PTZ)-induced increases in epilepsy-related gene expression.

“To date, anticonvulsant effects of the plant cannabinoid, cannabidivarin (CBDV), have been reported in several animal models of seizure. However, these behaviourally observed anticonvulsant effects have not been confirmed at the molecular level…

These results provide the first molecular confirmation of behaviourally observed effects of the non-psychoactive, anticonvulsant cannabinoid, CBDV, upon chemically-induced seizures and serve to underscore its suitability for clinical development.”

http://www.ncbi.nlm.nih.gov/pubmed/24282673

Full-text: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3840466/

Cannabis might be a better treatment for epilepsy sufferers -msn

Young marijuana plants (©AP Photo/Ted S. Warren)

“Cannabis is now apparently the cure for everything from cancer,  diarrhea, bipolar disorder and Multiple sclerosis, to an ailing economy and being a smart aleck teenager. The latest chronic illness to get the 4:20 treatment is epilepsy. British scientists from the University of Reading tested a compound in pot called cannabidivarin on rats and mice with six types of epilepsy, and found it “strongly suppressed seizures” without the unpleasant side effects of current anti-epilepsy drugs. With 1 percent of the world’s population suffering from the disease, the head of the research team, Ben Whalley, says there’s a pressing need for better treatments. “It’s a chronic condition with no cure and currently, in around one-third of cases, the currently available treatments do not work, cause serious side effects and increase fatalities,” he said.”

http://now.msn.com/epilepsy-treatment-found-in-cannabis-may-prove-better-than-current-methods

10-year-old is seizure-free after one year of cannabis oil

Zaki Jackson, seen here with his mom Heather, used to suffer through 200 seizures per hour. - COURTESY HEATHER JACKSON

“Amid the sounds of children laughing as they bounce and roll down a giant, red inflatable slide, a crowd of more than 150 gathers, making a half-circle around Heather Jackson.

“I want to thank you all so much for coming,” Jackson says. “There are some of you I don’t even know — which is awesome. Again, thank you for coming out and helping us celebrate Zaki’s first seizure-free year.”

The crowd applauds. Zaki, Jackson’s 10-year-old son, emerges from the crowd, smiling. His brow gleams from a light sweat, joyfully earned on the inflatable playground at Jump-N-Jacks, an indoor play facility on North Academy Boulevard. His mother puts one arm on his shoulder and fans him with a Realm of Caring laminated fact sheet.

He is normal. He is fine.

One year earlier, Mrs. Jackson sat with a friend who worked in hospice care, asking for advice concerning the next treatment for Zaki’s Doose syndrome, a form of epilepsy found early in childhood. There is no known cause, and the condition is often unresponsive to medication.

Zaki’s seizures began when he was 4 months old. At what his mother calls his “deepest valley,” he experienced thousands per day. A 2008 electroencephalography reading revealed more than 200 per hour. To combat this, the child underwent 17 different pharmaceutical treatments — all of which failed.

As recently as May 2012, Zaki would have between 60 and 200 seizures while he slept. “They were brief, but very violent,” Jackson says. “It was like someone was putting paddles to his chest. Then he began to have seizures where he would stop breathing.

“So my friend at hospice, she said to me, ‘I can’t tell you to try this, but there is this group of brothers who have helped treat a similar case with cannabis oil. I can’t tell you to try it, but here’s some phone numbers.'”

The brothers — Josh, Jordan, Jesse, Joel, Jon and Jared Stanley, cannabis growers and founders of Realm of Caring — created a strain of cannabis containing minimal THC, the psychoactive ingredient, and very high levels of cannabidiol (CBD), the ingredient considered to provide the most medicinal benefits.

At Zaki’s party, Josh Stanley explains: “We were reading these studies in Israel from the ’70s, ’80s, and ’90s — studies where they saw positive results on lab mice using high-CBD strains. So we decided to give it a try, originally focusing on aiding cancer patients. It was by luck that we discovered it could be so beneficial to those suffering from seizures.”

The “luck” came when Paige Figi contacted the Stanley brothers. She had read about high-CBD oils used to treat epilepsy in California. Her 6-year-old daughter, Charlotte, suffers from Dravet syndrome, and she was willing to try anything. The cannabis oil so helped Charlotte, they renamed the strain in her honor: Charlotte’s Web, of which Zaki takes 300 mg every day.

Realm of Caring’s 501(c)3 status is pending, but the Colorado Springs foundation hopes to become a nonprofit that can make alternate treatment affordable for families in need. Meanwhile, back at the party, Jackson announces that Zaki’s last clinical seizure took place Oct. 3, 2012. Her husband, Frank Jackson, presents the Stanley brothers with a wooden sign, which reads “Zaki’s Garden” at the top and “Thank you for my first seizure-free year” at the bottom.

Zaki moves past his mother’s arm, shuffles through the crowd, and speeds toward an inflatable ship as a few friends follow close behind.”

http://www.csindy.com/coloradosprings/10-year-old-is-seizure-free-after-one-year-of-cannabis-oil/Content?oid=2779991

FDA approves marijuana based drug

“The U.S. Food and Drug Administration has approved clinical trials of a cannabis-based drug and its effects on epilepsy. The treatment, Epidiolex, is 98 percent purified cannabidiol (CBD) made by GW Pharmaceuticals based out of the U.K.  

There are around 60 known chemicals contained in cannabis called cannabinoids. Tetrahydrocannabinol, also known as THC, is the main component responsible for the drug’s psychoactive nature. CBD, however, is the second most abundant cannabinoid in the cannabis and provides medicinal benefits without the “high.” Epidiolex will come in a viscous liquid form to be dispensed from syringes. A 25 milligram per meter or 100 milligram per meter will be the two strengths made available to those in the trials.

The FDA has approved of intermediate-sized clinical trials sponsored by two doctors. Dr. Orrin Devinsky, a professor in the Department of Neurology, Neuroscience and Psychiatry in the New York University School of Medicine and director of the NYU Comprehensive Epilepsy Center, and Dr. Roberta Cilio, a pediatric neurologist at the University of California, San Francisco, are set to follow 25 patients using Epidiolex as treatment for pediatric epilepsy.

On Oct. 4, at the NYU Langone Medical Center, Devinsky led a conference entitled, “Cannabidiols: Potential Use in Epilepsy & Other Neurological Disorders.” During the affair, Devinsky and Cilio led a presentation on planned trials on CBD in children with treatment resistant epilepsy. 

The D.C. – based Marijuana Policy Project’s Communications Director Mason Tvert responded to the news of the approved trials. “We’ve long known that marijuana has a variety of medical benefits,” Tvert said. Tvert added that the federal government clearly recognizes marijuana’s medicinal benefits and it’s a shame they hindered most research of it.

Maryland’s new marijuana law came into effect on Oct. 1, but its miniscule scope won’t have much effect. It deals with a small number of patients that would enroll in state-approved clinical studies. However, with no hospitals signed up to hold these studies, no visible changes are set to occur in the near future.

Now the country will wait and see if CBD can live up to the hype, and if the epileptic patients can find any relief from their disease.”

 By Bonnie Katz

http://www.thesentinel.com/mont/news/FDA-approves-marijuana-drug10-31-2013

“Cannabis-Based Epilepsy Drug Approved For Clinical Trials” http://www.medicaljane.com/2013/10/23/cannabis-based-epilepsy-drug-approved-for-clinical-trials/

Around The World, Researchers Begin Clinical Trials of Cannabis For Epilepsy

 
Many patients in the U.S. have turned to tinctures and oil extracts to help control their seizures (Photo: Luis Sinco/Los Angeles Times) 
 

“While a large body of anecdotal and laboratory evidence points to cannabis as an effective treatment for epilepsy, research in humans is just beginning to catch up.

 GW Pharmaceuticals – the UK-based company behind the natural cannabis spray Sativex – announced the start of the first round of clinical trials of a new cannabis treatment for epilepsy.

In the press release, Dr. Stephen Wright, Director of Research and Development at GW, said the company has spent years testing cannabis in pre-clinical models – which include cell cultures and animals.

So far, the drug is only known as GWP42006.

“We are pleased to have advanced GWP42006 to first dose in man, a significant milestone in the development of this novel product candidate. The decision to progress into Phase 1 follows several years of highly promising pre-clinical research.”

Dr. Ben Whalley, Senior Lecturer in Pharmacology at the Reading School of Pharmacy, added, “Our research collaboration with GW over the last several years has shown that GWP42006 not only exerts significant anticonvulsant effects in a wide range of preclinical models of seizure and epilepsy but is also better tolerated compared to existing anti-epileptic drugs.”

While the company has not disclosed the ingredients in the new drug, their latest animal study – which appears in the October issue of the British Journal of Pharmacology – showed positive results with two chemicals derived from cannabis: Cannabidiol (CBD) and cannabidivarin (CBDV).

Both were found to suppress seizures and increase survival across a range of different rat models of epilepsy.”

More: http://www.leafscience.com/2013/09/20/around-world-researchers-begin-clinical-trials-cannabis-epilepsy/

Both CBD and CBDV are produced naturally by cannabis. Unlike THC, these two compounds do not get patients high.

“Both CBD and CBDV are produced naturally by cannabis. Unlike THC, these two compounds do not get patients high.”

“GW Pharmaceuticals Commences Phase 1Clinical Trial of GWP42006” (to be marketed as “Epidiolex”),”as a Potential Treatment for Epilepsy”

EPIDIOLEX

“GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, “GW”) announced today it has commenced a Phase 1 clinical trial of product candidate GWP42006 for the treatment of epilepsy.

Over the last five years, GW has conducted an extensive pre-clinical cannabinoid research program in the field of epilepsy in collaboration with the University of Reading in the United Kingdom. This research has led to the emergence of a number of promising cannabinoid therapeutic candidates showing anti-epileptic effects.

GWP42006, one of the most promising of those candidates, is a non-psychoactive cannabinoid extracted from specific chemotypes of the cannabis plant which has shown the ability to treat seizures in pre-clinical models of epilepsy with significantly fewer side effects than currently approved anti-epileptic drugs1.

“We are pleased to have advanced GWP42006 to first dose in man, a significant milestone in the development of this novel product candidate. The decision to progress into Phase 1 follows several years of highly promising pre-clinical research,” stated Dr. Stephen Wright, Director of Research and Development at GW. “We believe that GWP42006 has the potential to become an important advance in the treatment of epilepsy, a condition for which there remains a substantial unmet medical need.””

More: http://www.gwpharm.com/Phase1Epilepsy.aspx

“GW Pharma Commences Phase 1 Clinical Trial Of GWP42006 For Treatment Of Epilepsy… GWP42006, is a non-psychoactive cannabinoid extracted from specific chemotypes of the cannabis plant which has shown the ability to treat seizures in pre-clinical models of epilepsy with significantly fewer side effects than currently approved anti-epileptic drugs.” http://www.nasdaq.com/article/gw-pharma-commences-phase-1-clinical-trial-of-gwp42006-for-treatment-of-epilepsy-20130918-00037

“A Study of the Safety and Tolerability of GWP42006 in Healthy Subjects…This study is currently recruiting participants.” http://clinicaltrials.gov/show/NCT01918735

“Driving directions to GW Pharma Limited and product information about EPIDIOLEX is provided. EPIDIOLEX is a product created by GW Pharma Limited in  Porton Down Science Park , Salisbury, , SP4OJR. The EPIDIOLEX  is a product related to Pharmaceutical and veterinary preparations and substances for the treatment of epilepsy, convulsions, seizures, Dravet syndrome, Lennox-Gastaut syndrome, intractable childhood epilepsy with generalized tonic-clonic seizures, generalized epilepsy with febrile seizures plus, Doose syndrome and chromosome disorders; pharmaceutical preparations and substances for the treatment of pediatric epilepsy; herbs for medicinal purposes; medicinal herbs; medicinal oils; medicinal infusions for the treatment of epilepsy; pure extracts of medicinal plants and herbs used for the treatment of epilepsy, convulsions and seizures; herb teas for medicinal purposes. The EPIDIOLEX product is now being marketed in the United States for sale. The EPIDIOLEX is in the category of  Pharmaceutical Products..

Get in contact with the owner, GW Pharma Limited of this EPIDIOLEX, or visit them at their place of business in the map. Write a review about the product with this EPIDIOLEX.

Or, contact the owner GW Pharma Limited of the  EPIDIOLEX trademark by filing a request to communicate with the Legal Correspondent   for licensing, use, and/or questions related to EPIDIOLEX. The correspondent of the EPIDIOLEX is  MICHELLE L. VISSER of RADER, FISHMAN & GRAUER PLLC, 39533 WOODWARD AVE STE 140, BLOOMFIELD HILLS, MI 48304-5098 “.

http://www.trademarkia.com/map/epidiolex-86007888.htm

Comes Now Epidiolex™ (FDA approves IND studies of CBD)

NYU Conference

“In response to urgent need expressed by parents of children with intractable epilepsy, the U.S. Food and Drug Administration is allowing Investigational New Drug studies of purified CBD (cannabidiol) as an anti-seizure medication. The “new drug” is being provided to physician-investigators by GW Pharmaceuticals, which has named its CBD product “Epidiolex™.”

More: http://www.beyondthc.com/comes-now-epidiolex-fda-approves-ind-studies-of-cbd/

New Cannabis Drug Approved For Trials In Children With Epilepsy

 (Photo: GW Pharmaceuticals)
 
 

“New Cannabis Drug Approved For Trials In Children With Epilepsy

 

A new cannabis-based drug made by GW Pharmaceuticals has been approved by the U.S. Food and Drug Administration (FDA) for two separate trials involving children with epilepsy.

The drug is made from purified cannabidiol (CBD) – a non-psychoactive compound in marijuana – and is being marketed under the name Epidiolex, reports O’Shaughnessy’s.

So far, the FDA has approved two Investigational New Drug studies of Epidiolex for pediatric epilepsy, which are being led by Orrin Devinsky, MD, at the NYU School of Medicine, and Roberta Cilio, MD, PhD, at the University of California, San Francisco (UCSF). Each will involve 25 children with epilepsy, and other studies are awaiting approval.

If all goes as planned, GW Pharmaceuticals’ Chairman Geoffrey Guy, MD, expects more studies to begin within months.

“In the coming months, if the FDA is comfortable about how things are going, there will be a number of senior epileptologists in major university centers throughout the U.S., each treating a couple of dozen patients with various epilepsies.”

GW Pharmaceuticals is best known for its cannabis-based spray called Sativex, which is approved in over 20 countries for the treatment of multiple sclerosis symptoms.

However, the company has spent recent years developing a drug for epilepsy. Preclinical studies sponsored by the company show that CBD, along with a related cannabinoid called CBDV, have the potential to reduce epileptic seizures. Anecdotal reports also suggest that CBD-rich cannabis extracts could be effective in treating epilepsy in children.

Unlike Sativex, Epidiolex is a liquid medicine that can be administered with a syringe dropper. According to the company, the drug contains more than 98 percent CBD, along with trace amounts of other cannabinoids.”

More: http://www.leafscience.com/2013/10/22/new-cannabis-drug-approved-trials-children-epilepsy/

“Comes Now Epidiolex™ (FDA approves IND studies of CBD)” http://www.beyondthc.com/comes-now-epidiolex-fda-approves-ind-studies-of-cbd/

Therapeutic potential of cannabinoid medicines.

Drug Testing and Analysis

“Cannabis was extensively used as a medicine throughout the developed world in the nineteenth century but went into decline early in the twentieth century ahead of its emergence as the most widely used illicit recreational drug later that century. Recent advances in cannabinoid pharmacology alongside the discovery of the endocannabinoid system (ECS) have re-ignited interest in cannabis-based medicines.

The ECS has emerged as an important physiological system and plausible target for new medicines. Its receptors and endogenous ligands play a vital modulatory role in diverse functions including immune response, food intake, cognition, emotion, perception, behavioural reinforcement, motor co-ordination, body temperature, wake/sleep cycle, bone formation and resorption, and various aspects of hormonal control. In disease it may act as part of the physiological response or as a component of the underlying pathology.

In the forefront of clinical research are the cannabinoids delta-9-tetrahydrocannabinol and cannabidiol, and their contrasting pharmacology will be briefly outlined. The therapeutic potential and possible risks of drugs that inhibit the ECS will also be considered. This paper will then go on to review clinical research exploring the potential of cannabinoid medicines in the following indications: symptomatic relief in multiple sclerosis, chronic neuropathic pain, intractable nausea and vomiting, loss of appetite and weight in the context of cancer or AIDS, psychosis, epilepsy, addiction, and metabolic disorders.”

http://www.ncbi.nlm.nih.gov/pubmed/24006213

http://onlinelibrary.wiley.com/doi/10.1002/dta.1529/abstract