At the end of June 2018, the Food and Drug Administration (FDA) approved a new medication to treat two rare forms of epilepsy. Epidiolex is the first approved prescription drug made from marijuana. With the ever-evolving dialogue on marijuana legalization, this approval has raised some questions.
What Is Epidiolex?
Epidiolex is meant for patients who suffer from Dravet and Lennox-Gastaut syndromes. These are two rare forms of epilepsy with very few effective treatments. Patients who have these syndromes go through frequent, severe seizures. Some patients can even suffer from seizures more than 100 times per day.
When combined with other epilepsy drugs, Epidiolex helps reduce seizures in patients 2 years old and over. It is effective for both children and adults. However, this new drug isn’t quite a type of medical marijuana.
Instead of using complete marijuana, Epidiolex relies on cannabidiol (CBD) to produce its effects. CBD is derived from the cannabis plant, but it contains no THC – the chemical that gets marijuana users high. CBD can also come from hemp. Research has yet to understand exactly why CBD helps patients with epilepsy, but it does have a pronounced effect.
In fact, people have already been using CBD oil to help treat children with epilepsy. Epidiolex is a pharmaceutical grade version of the oil, and the aim is for the new medication to provide a consistent government-regulated version of CBD to help with treatments for these two rare forms of epilepsy.
GW Pharmaceuticals produces the drug in the United Kingdom and has plans to continue importing the medicine to the United States. This bypasses many restrictions on manufacturing regulated substances.
Pennsylvania Marijuana Laws
As of April 2016, medical use of marijuana became legal within Pennsylvania. So long as patients receive approval from a qualified list of physicians, they can purchase and consume marijuana for medical purposes. The currently approved list of medical conditions includes:
- Lou Gehrig’s Disease (ALS)
- Multiple sclerosis
- Crohn’s disease
- Intractable seizures
- Parkinson’s disease
- Damage to spinal cord nervous tissue
- Inflammatory bowel disease
- Huntington’s Disease
- Untreatable cases of neuropathic and severe chronic pain
- Any terminal illness
The law also has restrictions on the types of medical marijuana allowed. Dispensaries may sell creams, gels, oils, pills, ointments, tinctures, liquids, and non-whole plant forms. Users may vaporize the product, but not smoke it. Patients who qualify can get a medical card that shows their approval for medical marijuana use.
Other than for approved medical uses, marijuana is still illegal for recreational purposes. However, some cities have decriminalized the possession of marijuana, such as Philadelphia and Pittsburgh.
What Epidiolex Means for Pennsylvania?
At this writing, Epidiolex is not yet available for sale. The Drug Enforcement Administration first must reclassify CBD as having federal medical approval, which should take place within three months.
Even though Epidiolex is not a complete marijuana product, the presence of CBD is likely to create some controversy in earning widespread medical approval. As it is, CBD’s legal status is already unclear, though the change in Drug Enforcement Administration classification is likely to change that status.
Under Pennsylvania law, epilepsy is one of the approved medical uses for marijuana. Epidiolex will likely not receive as much trouble entering the medical market as it will in other states that do not approve medical marijuana.
There isn’t much need for patients who already have effective methods for treating their epilepsy to switch to Epidiolex. However, those with Dravet and Lennox-Gastaut syndromes can look forward to having a new way to ease their symptoms after the drug receives full approval and enters the market.