Cannabinoid-based drug pipeline shows promise
In the United States, cannabis, also known as marijuana, is a controlled substance and is classified as a Schedule I agent (a drug with high potential for abuse, and no currently accepted medical use), according to the National Cancer Institute.
Chemical components of cannabis, called cannabinoids, activate specific receptors in the body to produce pharmacologic effects, particularly in the central nervous system and the immune system. There are commercially available cannabinoids, such as dronabinol (Marinol, Abbvie) and nabilone (Cesamet, Valeant Pharmaceuticals), that are approved for the treatment of cancer-related side effects. Several other indications are currently under investigation for the use of cannabinoid-based drugs.
“While there are a wide range of possible indications under investigation, a common area of development for the cannabinoid-based products is to treat resistant or refractory pediatric epilepsies,” says Chris Peterson, PharmD, director in the emerging therapeutics department at Express Scripts. “If approved by the FDA, these products could provide therapeutic options for patients who do not respond or have an inadequate response to current agents.”
Cannabinoid-based products show promise with regard to a number of illnesses, according to Constance Scharff, PhD, senior addiction research fellow and director of Addiction Research at Cliffside Malibu, a drug rehabilitation center in Malibu, California.
Scharff says cannabinoid-based pain relieving medications that do not have the same addictive or overdose potential as opioids could hit the market soon, which could help address the opioid abuse and overdose crisis. Additionally, she says studies show that cannabinoid-based medications could help with mental health disorders, such as PTSD and depression.
“There is a large pipeline beginning to emerge, with 90 cannabinoid-based products currently in development,” says Kent Runyon, compliance officer and vice president of community relations for Novus Medical Detox Center in New Port Richey, Florida. “The vast majority of pipeline products are in early stages of development, with 82% of the pipeline at the preclinical or discovery stages.”
GW Pharmaceuticals is one company developing cannabinoid-based medicines. One is cannabidiol, or CBD (Epidiolex), a proprietary oral solution of pure plant-derived CBD. At the end of the first half of 2017, the manufacturer says it will submit an NDA to the FDA for Epidiolex to treat seizures associated with Dravet syndrome and Lennox-Gastaut syndrome.
The other cannabinoid-based drug from GW Pharmaceuticals is nabiximols (Sativex), an oromucosal spray that contains the principal cannabinoids THC (tetrahydrocannabinol) and CBD, which are absorbed in the lining of the mouth. Sativex is approved for the treatment of multiple sclerosis spasticity in 30 countries outside the U.S.
Other cannabinoid-based pipeline agents include:
• Zynerba Pharmaceuticals’ ZYN002, a synthetic CBD formulated as a permeation-enhanced gel for transdermal delivery through the skin, is in phase 2 clinical development in patients with refractory epilepsy and patients with osteoarthritis of the knee. Zynerba also plans to initiate a phase 2 clinical trial for ZYN002 in patients with Fragile X syndrome, a genetic condition causing intellectual disability.
• Resunab (Corbus Pharmaceuticals), a first-in-class synthetic oral endocannabinoid-mimetic drug, is in phase 2 clinical trials for the treatment of multiple indications including cystic fibrosis and systemic lupus erythematosus.
“Thus far, the pivotal studies for these pipeline agents are compared to placebo,” says Farrah Wong, PharmD, director, pipeline and drug surveillance at OptumRx. “While safety information can be extracted from this data, how well these drugs work compared to currently marketed treatment options are unknown.”