US approves Epidiolex, first marijuana-derived drug

WASHINGTON - US regulators on Monday approved the first marijuana-derived drug ever to hit the US market, Epidiolex, which will be used to treat 2 rare and severe forms of childhood epilepsy.

Made by the British biopharma company GW Pharmaceuticals, Epidiolex uses purified cannabidiol, or CBD, which is one of more than 80 active compounds in the cannabis sativa plant, often known simply as marijuana.

"This is an important medical advance," said US Food and Drug Administration Commissioner Scott Gottlieb. 

"But it's also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use."

The drug is approved for use against Lennox-Gastaut syndrome and Dravet syndrome in patients two years of age and older, the FDA said.

Both forms of epilepsy cause severe seizures.

Dravet syndrome is a rare genetic condition that causes frequent fever-related seizures, involuntary muscle spasms and a potentially life-threatening state of continuous seizure activity requiring emergency medical care.

"Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others," said the FDA.

Like Dravet syndrome, Lennox-Gastaut syndrome also begins in childhood and causes multiple types of seizures. Most children affected develop learning problems, intellectual disability, delayed motor skills and need help with daily activities.

"For those living with intractable seizures caused by LGS and Dravet syndrome, Epidiolex represents a true medical advancement," said Philip Gattone, president and CEO of the Epilepsy Foundation. 

"Clinical development for these rare and severe conditions is essential, and today's news brings hope for these patients and their families that a new treatment option may have the potential to help better control their seizures."

RECLASSIFICATION NEEDED 

Before the drug can be made widely available, the US Drug Enforcement Administration must reclassify CBD, which is considered a Schedule 1 drug that has a high risk of abuse and no medical value because it is derived from marijuana.

A reclassification is expected within 90 days, according GW Pharmaceuticals. The drug should be available in the coming months.

Epidiolex will be marketed by Greenwich Biosciences, a subsidiary of GW Pharmaceuticals.

The European Medicines Agency is currently reviewing Epidiolex for treating seizures associated with LGS and Dravet Syndrome, with a decision on whether or not to recommend approval expected early next year.

Epidiolex's effectiveness was studied in three randomized clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome, comparing Epidiolex to a placebo. 

Across the board, the drug was shown to be effective in cutting the frequency of seizures.

Side effects included sleepiness, sedation, lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, weakness, insomnia, poor quality sleep and infections.

An advisory panel to the FDA recommended in April that the drug be approved.

The FDA is not required to follow the advisory panel's advice but usually does.

CBD does not cause intoxication or euphoria. That so-called "high" comes from a different compound in marijuana, known as tetrahydrocannabinol (THC).

source: news.abs-cbn.com

Colombian president legalizes medical marijuana

COLOMBIA - Colombia's President Juan Manuel Santos on Tuesday (December 22) signed a decree that legalizes medical marijuana, a move he says does not weaken the government's fight against illicit crops and drug trafficking.

Santos said the decree allows for the therapeutic use of marijuana.

"This decree allows for the issuing of licenses for the possession of marijuana seeds and for the cultivation of the plant for exclusively medical and scientific purposes, I repeat, for exclusively medical and scientific purposes. We want to promote the research and production of medicines made from cannabis, marijuana, as we do with any natural element that can alleviate illnesses and pain," he said.

Studies show marijuana can help treat pain and nausea and offers relief for sufferers of epilepsy and other conditions.

Growing, distributing and selling cannabis remains illegal. The South American country suspended spraying of illicit crops this year, citing cancer concerns related to the herbicide glyphosate.

"To allow for the medicinal use of cannabis isn't a move in the wrong direction, it doesn't go against our international commitments to control drugs, or against our policy of fighting drug trafficking," Santos told reporters after signing the decree.

Current law allows possession of up to 20 grams (20 ml) of marijuana or 20 marijuana plants for personal use. A recent study showed 11.5 percent of Colombians have used marijuana at least once.

The government said some companies, including foreign ones, are interested in producing and selling cannabis. There are no plans to fully legalize marijuana for recreational consumption or commercial sale, however, unlike in Uruguay, which fully legalized it in 2013.

Colombia, long a hub for narcotics production and trafficking, was once home to large marijuana cultivations. Much of the crop was smuggled to the United States before drug cartels began producing the more profitable cocaine.

Austria, Belgium, Canada, the Czech Republic, Finland, Israel and some U.S. states already allow medical cannabis use.

source: www.abs-cbnnews.com

Advocates pitch benefits of medical marijuana

MANILA -- Advocates of medical marijuana on Tuesday attempted to convince lawmakers of the positive use of the illegal plant in the field of medicine.

Various experts attended the hearing of the House Committee on Health to convince lawmakers to pass House Bill 4477, or the "Compassionate Use of Medical Marijuana Act,'' which was filed by Isabela 1st District Representative Rodolfo Albano III and has 69 co-authors.

The advocates, including a foreign doctor who shared his expertise through a video message, explained the medical significance of cannabis or marijuana.

They insisted that cannabis is a unique drug that has vast potential for treatment.

Marijuana is the only known plant that produces large amounts of a class of chemicals known as cannabinoids, which is naturally produced by the human body.

The cannabinoid system, only discovered roughly two decades ago, is responsible for the regulation and protection of the the body. Cannabis has been used to manage pain, fight inflammation, battle depression, and regulate appetite and sleep, among others.

It has been proven as an effective treatment against serious ailments like Post Traumatic Stress Disorder (PTSD), epilepsy, Parkinson's Disease, and Multiple Sclerosis.

Albano clarified that HB 4477 only seeks to legalize marijuana strictly for medical use only. The bill seeks to regulate the use of cannabis for treatment and medication of patients with debilitating medical conditions.

If enacted, a Medical Cannabis Regulatory Authority under the Department of Health will be established to regulate the medical use of marijuana.

Qualified patients will be given identification cards that will protect them from criminal liability for the use of medical cannabis.

source: www.abs-cbnnews.com