Cannabis Drug Has Successfully Treated Epilepsy

An experimental cannabis drug, Epidiolex, has been successful in treating children with a form of childhood epilepsy according to the results of a much-awaited clinical trial. This has gone on to double the value of shares of its makers GW Pharmaceuticals, much to the cheer of investors. Experts and drug analysts opined that this could propel the experimental drug’s sales to over $1 billion.

Cannabis Drug – Success in Trials

Cannabis Drug - Success in Trials
UK’s GW Pharmaceuticals is nearly on its way to getting FDA’s approval for a cannabis drug Epidiolex which passed the phase 3 clinical trial to prove its ability to treat children with a rare form of epilepsy. About 120 children with Dravet Syndrome, a congenital disorder, took part in the trial. This is the first trial out of the six that are planned or ongoing. The children were aged about 10 years.

The patients were also those that experienced an average frequency of 13 seizures in a month when the study started. Half of the recruits were randomly assigned to receive the cannabis drug Epidiolex, whereas the others received a placebo. At the end of the study period, the group that took Epidiolex had a median 39% reduction in the number of seizures experienced in a month’s time. The group that received the placebo had only a 13% reduction in the seizure numbers. According to the researchers, this result has high significance statistically.

Currently, there are two prescription cannabis drugs based on THC, the main active ingredient in cannabis. However, Epidiolex is the first ever drug that has been made with cannabidiol, the plant’s second main active ingredient. It is interesting to note that there is yet another drug for multiple sclerosis, a creation of GW Pharmaceuticals, which carries a combination of THC and cannabidiol. This drug is not yet available in the United States.

Dravet Syndrome is a difficult-to-treat epilepsy condition. According to Dr. Orrin Devinsky, the success of the cannabis drug in the phase 3 trial reflects the efficacy and safety of pharmaceutical cannabidiol on children with the condition.

Some of the mild side effects experienced by the children in the trials were drowsiness, diarrhea, and reduced appetite. About ten patients experienced severe side effects and 8 stopped the treatment altogether. In the placebo group, only 1 patient discontinued with the treatment. About 84 percent of the patients that experienced side effects rated them as mild or moderate.

Prospects for GW Pharmaceuticals

With positive results that came of the phase 3 clinical trial of Epidiolex, the share prices of GW Pharmaceuticals more than doubled. In intraday trading, the company’s stock went up by 139 percent. The cannabis drug is predicted to generate sales of over $1.1 billion by the end of the decade for the company.

This study of the cannabis drug is the first one of the four phase 3 trials that was slated to take place. The results are expected this year and will confirm the healing benefits of the cannabidiol, derived from marijuana. Justin Gover, CEO of GW Pharmaceuticals, said that the company is excited about the prospects of Epidiolex becoming the first ever FDA-approved drug for the treatment of Dravet Syndrome in children. In this connection, the company officials are also planning a meeting with US FDA to discuss methods of seeking regulatory approval for the cannabis drug.

Interestingly, Epidiolex, the cannabis drug that is administered as syrup to children, is being additionally tested in phase 3 trials for yet another rare form of epilepsy, Lennox Gastaut Syndrome. The results are expected this year. The drug is due to be tested for its use in tuberous sclerosis complex, another indication in epilepsy. In the meanwhile, the company has also been scaling production capability of the cannabis drug in the light of the new developments.

According to GW, as many as 30 percent of child epilepsy patients are not helped by using the epilepsy medicines that are currently available in the market. They are dependent on the marijuana extracts that are sold by medical marijuana dispensaries. Company sources also said that hundreds of patients, both children and younger adults, have been using the cannabis drug Epidiolex under specific programs (outside trials) which allow them to have the drug.

Maryland Bill To Decriminalize Possession Of Small Amounts Of Drugs

As the number of deaths from the overdose of drugs is increasing throughout the nation, the Maryland Delegate Dan Morhaim – a practicing physician has introduced four separate bills to completely alter the drug policy in Maryland. The fourth bill, the Maryland House Bill 1119, decriminalizes the use and possession of extremely small amounts of drugs. Instead of reducing the use of drugs, criminalizing the users of drugs increases the stigma, amplifies the risks of overdose of drugs, and drives the users away from the required treatment and harm reducing services. The main aim of the bill is to keep the drugs users possessing minimal amounts of drugs out of the system of criminal justice and save critical resources and expenses involved in saddling more citizens involved in drugs related crime. The country, which initiated the law for eliminating penalties for the low-level possession of illegal drugs, was Portugal in 2001.

Clauses of the Bill

In addition to limiting the penalties for the possession and the use of de minimis amounts of drugs, the bill aims at penalizing the people involved in possessing, using less than 10 grams of marijuana drugs, or using, possessing the de minimis amount of a controlled dangerous substance. The bill aims to explain the provisions for the issuance of citations to the users possessing or using less than 10 grams of marijuana drugs or using and possessing the de minimis amount of controlled dangerous substance specified. The definitions of the de minimis amounts in the bill are:

  • 10 grams of marijuana
  • 2 grams of cocaine
  • 1 gram of heroin
  • 10 tablets of MDMA
  • 0015 grams of LSD
  • 1 gram of methadone
  • 1 gram of amphetamine

According to the clauses in the bill, the person possessing or using marijuana drugs cannot be fined for more than $1000 or imprisoned for more than a year or both. If the user is a first time user , and is caught possessing or using the de minimis amount , then he cannot be fined for more than $100 and if it is the second time , he cannot be fined more than $250 and if it is the third violation , then he cannot be fined for more than $500.

About Dan Morhaim

Dan Morhaim has been an active member of the Maryland House of Delegates since the beginning of 1994. He serves as a Deputy Majority Leader in the House of Delegates. He is a certified physician who has been in practice for more than 30 years. He has always been in the front line, always treating patients in the internal and emergency medicine. He is an important part of the faculty at Johns Hopkins Bloomberg School of Public Health and at University of Maryland Medical School. He has written numerous medical journals and books.

About Dan Morhaim

Prerequisites to fines

Some conditions are imposed alongside the fines. If a person below 21 or 21 is caught committing a violation which is punishable under the subparagraph 1,2 and 3 of this subparagraph, he shall be ordered to visit a drug education center that has been approved by the Department of Health and Dental Hygiene. He will undergo an assessment or test for substance abuse disorder and will undergo treatment if required. If a user is caught smoking marijuana in a public place, he is not to be fined more than $500. If a police officer cites a person possessing the de minimis quantity of the drug, then the citation will have to include the address and the name of the person charged, the time and date when the violation was committed, the value of the fine that is liable to be imposed, and a notice stating the allowance of the prepayment of the fine has to be issued. If a person who is under 21is caught, he will be called for trial. However, if a person is below 18, he will be subject to the Title 3, Subtitle 8A of the Courts Article.