Thursday, September 27 marks a historic day. Today the DEA (United States Drug Enforcement Administration) scheduled the first marijuana based medication.
Epidiolex(r) is a FDA approved medication that is made up of highly-purified, plant-derived cannabidiol (CBD) in a proprietary oral solution of pure plant-derived cannabidiol or CBD and was scheduled today at a “V”. Epidiolex(R) will be used for, early-onset, treatment-resistant epilepsy syndromes including Dravet syndrome, Lennox-Gastaut syndrome (LGS) and Tuberous Sclerosis Complex (TSC). The release of the drug will mark the first time that such a prescription drug has been made available to the U.S. public and now is available for sale in the U.S. The company needs to finalize the product label for the drug and expects to have it ready for customers in six weeks. Greenwich Biosciences, GWPH’s U.S. subsidiary, will be marketing the drug in America.
This scheduling is historic in that level V is reserved for drugs, substances, or chemicals defined as drugs with lower potential for abuse than other schedules. Example: Schedule V drugs are generally used for antidiarrheal, antitussive, and analgesic purposes. Some examples of Schedule V drugs are cough preparations with less than 200 milligrams of codeine or per 100 milliliters (Robitussin AC), Lomotil, Motofen, Lyrica, Parepectolin.
We also hope this will open the door on how marajuania is schedule. Currently it is a “Level I”, consistent with heroin and other addictive drugs. This scheduling has made it very restrictive to nearly impossible to gain access to it for valid medical research. Example, Epidiolex(r) was developed in the UK prior to U.S. FDA approved medical trials.
For more on understanding scheduling read on.
What is Drug Scheduling
Drugs, substances, and certain chemicals used to make drugs are classified into five (5) distinct categories or schedules depending upon the drug’s acceptable medical use and the drug’s abuse or dependency potential. The abuse rate is a determinate factor in the scheduling of the drug; for example, Schedule I drugs have a high potential for abuse and the potential to create severe psychological and/or physical dependence. As the drug schedule changes– Schedule II, Schedule III, etc., so does the abuse potential– Schedule V drugs represents the least potential for abuse. A Listing of drugs and their schedule are located at Controlled Substance Act (CSA) Scheduling or CSA Scheduling by Alphabetical Order. These lists describes the basic or parent chemical and do not necessarily describe the salts, isomers and salts of isomers, esters, ethers and derivatives which may also be classified as controlled substances. These lists are intended as general references and are not comprehensive listings of all controlled substances.
Please note that a substance need not be listed as a controlled substance to be treated as a Schedule I substance for criminal prosecution. A controlled substance analogue is a substance which is intended for human consumption and is structurally or pharmacologically substantially similar to or is represented as being similar to a Schedule I or Schedule II substance and is not an approved medication in the United States. (See 21 U.S.C. §802(32)(A) for the definition of a controlled substance analogue and 21 U.S.C. §813 for the schedule.)
Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse. Some examples of Schedule I drugs are:
heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), 3,4-methylenedioxymethamphetamine (ecstasy), methaqualone, and peyote
Schedule II drugs, substances, or chemicals are defined as drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence. These drugs are also considered dangerous. Some examples of Schedule II drugs are:
Combination products with less than 15 milligrams of hydrocodone per dosage unit (Vicodin), cocaine, methamphetamine, methadone, hydromorphone (Dilaudid), meperidine (Demerol), oxycodone (OxyContin), fentanyl, Dexedrine, Adderall, and Ritalin
Schedule III drugs, substances, or chemicals are defined as drugs with a moderate to low potential for physical and psychological dependence. Schedule III drugs abuse potential is less than Schedule I and Schedule II drugs but more than Schedule IV. Some examples of Schedule III drugs are:
Products containing less than 90 milligrams of codeine per dosage unit (Tylenol with codeine), ketamine, anabolic steroids, testosterone
Schedule IV drugs, substances, or chemicals are defined as drugs with a low potential for abuse and low risk of dependence. Some examples of Schedule IV drugs are:
Xanax, Soma, Darvon, Darvocet, Valium, Ativan, Talwin, Ambien, Tramadol
Schedule V drugs, substances, or chemicals are defined as drugs with lower potential for abuse than Schedule IV and consist of preparations containing limited quantities of certain narcotics. Schedule V drugs are generally used for antidiarrheal, antitussive, and analgesic purposes. Some examples of Schedule V drugs are:
cough preparations with less than 200 milligrams of codeine or per 100 milliliters (Robitussin AC), Lomotil, Motofen, Lyrica, Parepectolin
Treating epilepsy presents a variety of challenges for patients and their families. Sometimes, it takes time to find the right medication and dosing to properly manage seizures and other epilepsy-related health issues. Or it may be necessary to adjust the medication so that it doesn’t cause side effects that impact quality of life. This is especially true for patients with two rare forms of severe childhood-onset epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.
In the search for new treatments for these rare forms of epilepsy, researchers have been studying marijuana-based drugs for their potential seizure-controlling benefits. In June, the FDA approved cannabidiol (CBD), a marijuana-based medication, for the treatment of seizures in patients (age 2 and older) who have been diagnosed with Lennox-Gastaut syndrome or Dravet syndrome.
Here, epilepsy expert Elaine Wyllie, MD, explains the science behind the new treatment, common side effects and guidance for use.
Q: How is CBD different from marijuana?
A: Unlike marijuana, CBD does not contain tetrahydrocannabinol (THC), the chemical that causes users to feel high. Since the THC has been removed, researchers believe that CBD treatment is likely to involve a low risk of abuse or addiction. The U.S. Drug Enforcement Administration will soon reclassify CBD in a medication category among other drugs that have received federal approval for medical use.
Q: What research was used to evaluate CBD?
A: The FDA reviewed the results from three clinical trials involving more than 500 children and adults with either Lennox-Gastaut syndrome or Dravet syndrome. The researchers conducted randomized, placebo-controlled, double-blind studies that followed strict guidelines to ensure accurate and reliable results.
The following results demonstrate the efficacy of CBD:
Patients with Lennox-Gastaut syndrome who received CBD experienced a 37 percent to 42 percent reduction in drop seizures (involving muscle stiffening or limpness in the body, trunk or head, which can cause a patient to fall).
About 43 percent of patients with Dravet syndrome who were treated with CBD had a 50 percent or greater reduction in convulsive seizures — compared with 27 percent of placebo patients.
Q: What are the side effects of CBD?
A: The most common side effects were sleepiness and lethargy. A few patients reported diarrhea, vomiting, unsteadiness or decreased appetite.
During the study, some patients experienced mild liver abnormalities — especially if they were also taking the seizure drug valproate (Depakote®). Once CBD was discontinued, however, their liver function readings on blood tests returned to normal.
Q: Is CBD known to interact with other medications?
A: Some patients who took CBD experienced interactions with other seizure medications. For example, CBD increased the level of one of the components of the seizure drug clobazam (Onfi®) in the bloodstream, which caused some patients to feel sleepy. During the clinical trials, CBD mildly affected some other seizure drugs; however, the impact was inconsequential.
Q: What is the approved dosing schedule for CBD?
A: CBD will be available as a twice-daily oral solution — under the brand name Epidiolex®.
Q: When will CBD be available by prescription, and what is the FDA guidance for use?
A: By fall 2018, pharmacies anticipate CBD’s availability by prescription only. At that time, the manufacturer will provide physicians and families with comprehensive information and guidance that details the safe use of CBD. This is unlike other marijuana-based products, which have not been subjected to a stringent FDA approval and quality-controlled manufacturing method.
Q: What about using CBD to treat other forms of epilepsy?
A: You may ask your doctor about taking CBD for epilepsy conditions other than Dravet syndrome or Lennox-Gastaut syndrome. While physicians can legally prescribe FDA-approved drugs for conditions other than those involved in the clinical trials, such “off-label” use of medications mandates thoughtful analysis and specialized medical expertise. Additional research is needed to clearly define the range of patients who may benefit from CBD treatment.
Q: How do I know if this new treatment is right for me?
A: Talk to your epilepsy specialist to discuss whether you may benefit from CBD.
Source: Cleveland Clinic
Note: EpilepsyU will be hosting s seminar on Facebook Live on November 3, 2018 on CBD. Be watching for announcements.
Despite limited evidence, Americans have an increasingly positive view of the health benefits of marijuana. Nearly two-thirds believe pot can reduce pain, while close to half say it improves symptoms of anxiety, depression, epilepsy, and multiple sclerosis, according to a new online survey of 9,003 adults.
Pennsylvania and New Jersey are among the 30 states, along with the District of Columbia, Guam, and Puerto Rico, that have legalized medical marijuana. But scientists say hard data on the health effects of pot — both positive and negative — are largely missing. Because marijuana is considered an illicit drug by the federal government, research has been scant, though there are efforts underway in Pennsylvania and nationally to remedy that.
“I am not surprised at all [by the survey]. At the same time, I’m a little bit disturbed,” said Antoine Douaihy, senior academic director of addiction medicine services at the University of Pittsburgh Medical Center. He was not involved in the study.