Here’s what’s next now that the FDA has approved a cannabis drug for seizures

The US Food and Drug Administration approved the first cannabis-derived drug this week, but it can’t be sold until the Drug Enforcement Administration changes how it classifies the specific compound used. So what’s next?

Epidiolex treats serious forms of childhood epilepsy and contains the compound cannabidiol (CBD). Though CBD comes from cannabis, it won’t cause anyone to get high; it’s the compound THC that is psychoactive. But because it comes from cannabis and cannabis overall is classified as a Schedule I drug with “no currently accepted medical use and a high potential for abuse,” pharmaceutical companies aren’t allowed to sell it unless the DEA reclassifies CBD.

It is likely that the DEA will reclassify CBD in the next 90 days, says Stephanie Yin, an analyst at Informa Pharma Intelligence. (Epidiolex manufacturer GW Pharmaceuticals has said the same.) Most likely, according to Yin, it will be changed to Schedule IV or Schedule V, which are schedules that include other anti-seizure medications and anxiety drugs like Xanax and Klonopin.

THIS WILL ENCOURAGE OTHER COMPANIES TO DEVELOP CBD DRUGS FOR EVERYTHING FROM PAIN TO MULTIPLE SCLEROSIS

This doesn’t mean that cannabis as a drug will be removed from Schedule I though. Yin points out that the FDA already approved two nausea drugs — dronabinol and nabilone — that use synthetic versions of THC. The DEA scheduled these drugs as Schedule III and II, respectively, but still didn’t reschedule cannabis. Plus, FDA Commissioner Scott Gottlieb said in a press release that Epidiolex approval “is not an approval of marijuana or all of its components.”

If these synthetic THC drugs can be approved and rescheduled, and CBD can be rescheduled, what’s keeping the DEA from rescheduling cannabis itself? “Cannabis contains so many different compounds and strains,” explains Yin. “The FDA has just approved this singular product through stringent testing and doses and specific concentrations. It’s gone through rigorous clinical reviews and FDA review, but the FDA is likely to still crack down on claims made with other products.”

To be clear, there are already plenty of CBD products easily available, from supplements to oils to various beauty products like soap. But it’s one thing to sell them as supplements, and another to sell them as drugs. “You can get vitamin C from oranges at the grocery store, or you can get a clinical preparation of vitamin C to treat a disease, and those two items are treated very differently,” says Chris Stubbs, chief science officer of hemp farming and genetics company GenCanna. Clinical CBD is much more tightly regulated.

Still, the reclassification will likely make medical cannabis more legitimate. Rite Aid, for example, has already said it will fill prescriptions for Epidiolex, which is likely to be available at pharmacies in the fall. (It won’t be available in dispensaries because FDA-approved drugs can only be sold at places with a pharmaceutical license.) And GW Pharmaceuticals is already investigating other CBD-derived drugs to treat different forms of epilepsy, as well as forms of brain cancer and schizophrenia. “This approval is definitely going to encourage other companies to investigate [other cannabis] compounds for different diseases,” she says, “from pain to Alzheimer’s to multiple sclerosis to Tourettes’. Basically a whole spectrum of diseases.”

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U.S. approves first prescription drug made from marijuana

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The FDA approved a CBD-based medication to treat two rare forms of epilepsy that begin in childhood

WASHINGTON — U.S. health regulators on Monday approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use.

The Food and Drug Administration approved the medication, called Epidiolex, to treat two rare forms of epilepsy that begin in childhood. But it’s not quite medical marijuana.

The strawberry-flavored syrup is a purified form of a chemical ingredient found in the cannabis plant — but not the one that gets users high. It’s not yet clear why the ingredient, called cannabidiol, or CBD, reduces seizures in some people with epilepsy.

British drugmaker GW Pharmaceuticals studied the drug in more than 500 children and adults with hard-to-treat seizures, overcoming numerous legal hurdles that have long stymied research into cannabis.

FDA officials said the drug reduced seizures when combined with older epilepsy drugs.

The FDA has previously approved synthetic versions of another cannabis ingredient for medical use, including severe weight loss in patients with HIV.

Epidiolex is essentially a pharmaceutical-grade version CBD oil, which some parents already use to treat children with epilepsy. CBD is one of more than 100 chemicals found in marijuana. But it doesn’t contain THC, the ingredient that gives marijuana its mind-altering effect.

Physicians say it’s important to have a consistent, government-regulated version.

“I’m really happy we have a product that will be much cleaner and one that I know what it is,” said Ellaine Wirrell, director of the Mayo Clinic’s program for childhood epilepsy. “In the artisanal products there’s often a huge variation in doses from bottle to bottle depending on where you get it.”

Side effects with the drug include diarrhea, vomiting, fatigue and sleep problems.

Several years ago, Allison Hendershot considered relocating her family to Colorado, one of the first states to legalize marijuana and home to a large network of CBD producers and providers. Her 13-year-old daughter, Molly, has suffered from severe seizures since she was 4 months old. But then Hendershot learned about a trial of Epidiolex at New York University.

“I preferred this to some of those other options because it’s is a commercial product that has gone through rigorous testing,” said Hendershot, who lives in Rochester, New York.

Since receiving Epidiolex, Hendershot says her daughter has been able to concentrate more and has had fewer “drop” seizures — in which her entire body goes limp and collapses.

CBD oil is currently sold online and in specialty shops across the U.S., though its legal status remains murky. Most producers say their oil is made from hemp, a plant in the cannabis family that contains little THC and can be legally farmed in a number of states for clothing, food and other uses.

The impact of Monday’s approval on these products is unclear.

The FDA has issued warnings to CBD producers that claimed their products could treat specific diseases, such as cancer or Alzheimer’s. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions.

Most CBD producers sidestep the issue by making only broad claims about general health and well-being.

Industry supporters downplayed the impact of the FDA approval.

“I don’t know a mom or dad in their right mind who is going to change what’s already working,” said Heather Jackson, CEO of Realm of Caring, a charitable group affiliated with Colorado-based CW Hemp, one of nation’s largest CBD companies. “I really don’t think it’s going to affect us much.”

Jackson’s group estimates the typical family using CBD to treat childhood epilepsy spends about $1,800 per year on the substance.

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A GW Pharmaceuticals spokeswoman said the company would not immediately announce a price for the drug, which it expects to launch in the fall. Wall Street analysts have previously predicted it could cost $25,000 per year, with annual sales eventually reaching $1 billion.

For their part, GW Pharmaceuticals executives say they are not trying to disrupt products already on the market. The company has pushed legislation in several states to make sure its drug can be legally sold and prescribed.

The FDA approval for Epidiolex is technically limited to patients with Dravet and Lennox-Gastaut syndromes, two rare forms of epilepsy for which there are few treatments. But doctors will have the option to prescribe it for other uses.

The new medication enters an increasingly complicated legal environment for marijuana.

Nine states and the District of Columbia have legalized marijuana for recreational use. Another 20 states allow medical marijuana, but the U.S. government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD.

Despite increasing acceptance, there is little rigorous research on the benefits and harms of marijuana. Last year a government-commissioned group concluded that the lack of scientific information about marijuana and CBD poses a risk to public health.

Before sales of Epidiolex can begin, the Drug Enforcement Administration must formally reclassify CBD into a different category of drugs that have federal medical approval.

GW Pharmaceuticals makes the drug in the U.K. from cannabis plants that are specially bred to contain high levels of CBD. And the company plans to continue importing the medicine, bypassing onerous U.S. regulations on manufacturing restricted substances.

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Portugal’s parliament legalizes cannabis-based medicines.

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LISBON (Reuters) – Portugal’s parliament overwhelmingly approved a bill on Friday to legalize marijuana-based medicines, after rejecting earlier proposals to allow patients to grow the drug at home.

Portugal decriminalized the use of all drugs in 2001 to fight a heroin epidemic, and has legal plantations growing marijuana products for export. But it had trailed EU countries such as Italy and Germany, as well as Canada and parts of the United States on medical marijuana.

Only one party, the center-right CDS-PP, abstained in the vote in parliament legalizing marijuana-based prescription drugs to treat chronic pain, post traumatic stress disorder, side effects from cancer therapy, and some other ailments.

The bill now goes to President Marcelo Rebelo de Souza to be signed into law.

All drugs will need a license from regulator Infarmed, the body which last year authorized a medical marijuana plantation in central Portugal growing plants with a high content of psychoactive ingredient THC for export.

Portugal, on the Atlantic coast has a warm temperate subtropical climate, with mild winters, warm summers and lots of sunny days, which is often compared to that of California, making it an ideal place for cannabis cultivation.

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New Study Suggests Marijuana Users Have a Decreased Risk of Atrial Fibrillation and In-Hospital Mortality

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Once upon a time smoking marijuana was considered to be completely detrimental to your health and to be avoided at all costs. Now medical experts are beginning to backtrack a little.

A new study involving more than one million patients has demonstrated that marijuana users actually had a decreased risk of both atrial fibrillation (AFib) and in-hospital mortality following a heart attack. Results of which were presented at the Heart Rhythm Society’s 39th Annual Scientific Sessions last month.

According to federal data, between the years of 2002 and 2014, there’s been a staggering 455% increase in the consumption of marijuana among people in the U.S. aged between 55-64. For those aged 64 and over, there’s been a 333% increase. It’s also estimated that as many as one in eight Americans smoke marijuana.

While previous studies have demonstrated a link between cannabis use and increased heart rate and blood pressure, not much is known about the effects of heart arrhythmias such as VT and VF. VT is a fast but regular heartbeat that may lead to VF which is a fast and irregular beat that could cause sudden cardiac arrest.

The study involved comparing in-hospital outcomes with clinical profiles in both marijuana users and non-marijuana users between the years of 1994 to 2013. All patients were aged between 18-70 years old and all had a primary diagnosis of AMI.

A total of 3,854 patients out of 1,273,897 who were admitted with AMI were marijuana users. The study also revealed that most of these patients were young males. Of those experiencing cardiac arrest of VT/VF, 9.7% were marijuana users and 9.7% weren’t. Of those that had AFib, 4.5% were marijuana users while 8.7% were non-users. The figures for death were 4% and 6% respectively.

“The legalization of marijuana is spreading quickly across the U.S. resulting in more people using it, but we still don’t know the true, long-term impact it has on one’s heart health,” says Christine Tomkins MD, senior author of the study and assistant professor of cardiology medicine at University of Colorado School of Medicine. “Our study is the first to examine the relationship between marijuana use after a heart attack and various arrhythmias and we did not see a negative connection.”

In order to better understand the link between marijuana and arrhythmias in chronic ischemic heart disease patients future studies are needed, note the authors. They also confirm the need to understand how marijuana affects the heart as the number of users over the age of 50 is increasing significantly.

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