Category Archives: Epilepsy

FDA approves marijuana based drug

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“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

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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”

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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)

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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

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 (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.

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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

The secret “spice”: an undetectable toxic cause of seizure.

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“”Spice” is an umbrella term for a variety of synthetic cannabinoid products whose inhalation has been associated with an increasing number of toxic side effects resulting in emergency department visits. These side effects (including psychosis, tachyarrhythmia, and seizures) are not typically seen with marijuana (Cannabis sativa) use.”

http://www.ncbi.nlm.nih.gov/pubmed/23983854

Family: medical marijuana could help son with rare disease

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 “”Everybody loves Charlie,” boasted father, Eric Byrd,”he’s just always smiling, it’s his personality, he just glows.”

Charlie Byrd looks like every little five-year-old boy and has a smile that will melt your heart. But Charlie is in a dangerous battle for his life against a rare, and even deadly, form of epilepsy called “Dravet Syndrome.”

“He keeps smiling and he doesn’t even know that he’s sick,” said Crystal Byrd, Charlie’s mother, through tears.

The Byrds say the first seizure happened when Charlie was just a few months old, the second came just a few months later when he was six months old. From there the hospital trips added up, as did the pain and the seizures.

“We quit counting, it had become a little hard to deal with,” stated Charlie’s mom.

The Byrds have given their only son everything they can find.

“We’ve tried numerous therapies, medicines, and nothing’s ever worked,” said Eric Byrd, “Today, he’s on four different types of anti-epileptic drugs. This morning he had two seizures in his sleep.”

The West Liberty family even started the young boy on medicine from other countries after doing research. Along the way they connected with other families with children battling “Dravet Syndrome.”

One case stands above the rest. Crystal Byrd pointed to a girl in Colorado who seems to have found a strong remedy, “The child went from 300 seizures to one a week, and sometimes the one-a-week doesn’t even come.”

The medicine, though, is only legal in 19 states and Kentucky isn’t one of them.

“It was the medical marijuana, the CBDs,” answered Crystal.

CBD, or cannabidiol, isn’t like other forms of marijuana, as Crystal explained, she’s not giving her son a cigarette. Instead, she said it can come in the form of an oil or even pill.

“He won’t be high from it, it doesn’t have the taboo marijuana association with it,” she said.

Still, the topic of legalizing marijuana even in medical cases has been, at times, controversial. Yet, it is on the table for politicians to consider in a Wednesday meeting in Frankfort. According to the agenda, advocates for medicinal marijuana, patients, doctors, and even a former narcotics officer will speak before a committee of state lawmakers.

The Byrds are anxious. They say if medical marijuana isn’t allowed, then they might be looking to move to a state that does allow it, like Colorado.

“I can see through conservatory, but I mean how can you look at him and not want to give him a chance?” asked Crystal Byrd.”

http://www.wkyt.com/home/headlines/Family-medical-marijuana-could-help-son-with-rare-disease-220452801.html

Marijuana stops child’s severe seizures

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“Saundra Young of CNN.com delved into the heated debate of medical marijuana and children, in her story about a little girl who has a rare, and severe form of epilepsy called Dravet Syndrome. While the debate continues, the pro-legalization side may have won a small victory in the form of Charlotte Figi, 6, who was given her life back by marijuana…

Desperate for a treatment, Charlotte’s father Matt searched the Internet and eventually found a boy with a similar case in which medical marijuana helped his seizures. The Figi’s turned to the Stanley brothers, one of Colorado’s largest marijuana growers and dispensary owners, for help.

“These six brothers were crossbreeding a strain of marijuana low in THC, the compound in marijuana that’s psychoactive, and high in CBD, which has medicinal properties but no psychoactivity,” writes Young. But the Stanley brothers didn’t know what to do with this particular strain, as no one seemed to want to buy it. Then they met Charlotte.

The first time Charlotte tried a small dose of cannabis oil, the results were astounding:

“When she didn’t have those three, four seizures that first hour, that was the first sign,” Paige recalled. “And I thought well, ‘Let’s go another hour, this has got to be a fluke.'”

The Stanley brothers started the Realm of Caring Foundation, a nonprofit organization that provides this particular strain of medical marijuana to adults and children suffering from a host of diseases. The strain used by Charlotte and 41 other patients is affectionately called Charlotte’s Web.

Charlotte’s seizures stopped for seven days after her first dose and today she is eating, and walking on her own — even riding a bike, her parents say. Charlotte gets a dose of the cannabis oil twice a day in her food and her seizures are down to 2 to 3 per month.

“I literally see Charlotte’s brain making connections that haven’t been made in years,” Matt said. “My thought now is, why were we the ones that had to go out and find this cure? This natural cure? How come a doctor didn’t know about this? How come they didn’t make me aware of this?”

Read the full article on CNN.com.”

More: http://www.philly.com/philly/health/Marijuana_stops_childs_severe_seizures.html

Modesto, Calif. dad turns to medical marijuana to save son

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“Jason David from Modesto chronicles the ups and downs with his 6-year-old son Jayden, who was diagnosed with Dravet syndrome, on a Facebook page called Jason and Jayden’s Journey.” https://www.facebook.com/jasonandjaydensjourney

“Jayden was diagnosed with Dravet, a rare form of epilepsy, when he was a baby. Since then, he has had seizures preventing him from walking, playing and living life.

“At one point Jayden had seizures 24 hours a day lasting an hour and a half,” David said. “I went to my doctor and said, ‘I don’t think Jayden is going to last, he can’t sleep, can’t eat, he hasn’t used the restroom, he can’t do anything.'” 

David said his son has been taken away in an ambulance more than 40 times. He’s also taken 22 pills a day — 12 different kinds and none of them worked.

David said it got so bad that he wanted to kill himself and put a gun to his head.

But now, those thoughts are long gone.

As a last resort, David turned to medical marijuana. Specifically, a liquid form that contains a component known as CBD.

Jayden’s pediatrician prescribes it to Jayden and says the liquid form maintains medicinal qualities, while giving less of a high.

Jayden has been getting a few drops a day for the past two years and David said it’s been a remarkable difference.

Jayden is the most independent he’s ever been. He plays well, can walk and give his dad high fives, David said.

“(The) first day I gave him medical marijuana, thank God. (It was) the first day he went seizure free in his life,”he said.

David said he wants to share his story to help other parents in the same situation.

He says parents need to educate themselves and do what’s right for their own children.

The father and son have been featured in numerous articles and television shows. Jason and Jayden will be featured as a small piece in a special about medical marijuana with Dr. Sanjay Gupta that airs Sunday on CNN.

Jayden’s pediatrician said he is seeing more children with autism and seizures who are benefiting from medical marijuana.

The doctor admits not a lot of studies have been done on medicinal marijuana, which is why doctors across the board may have differing opinions.

However, doctors at the University of California-San Francisco are now studying the affects the CBD component in medical marijuana has on epileptic children.”

http://www.kcra.com/news/modesto-calif-dad-turns-to-medical-marijuana-to-save-son/-/11797728/21403126/-/item/0/-/12mmupr/-/index.html