The Clinical Progression Of Medicinal Cannabis Treatment

By: Abdus-Salaam Muwwakkil

Background

When President Richard Nixon signed the Controlled Substances Act in 1970, marijuana was designated as a schedule I drug. Drugs in this group are defined as having a “high potential for abuse” and “no current medical use”. One of the largest hurdles for insuring marijuana rests on US Food and Drug Administration (FDA) approval. This approval is prime factor for determining widespread usability for the marijuana plant as a medical treatment. However, there exists a growing number of cannabis extractions that are being approved for medical research and treatment by the FDA, which is leading some cannabis experts to foresee federal approval across the board for medical marijuana in the very near future.


Systematic Progression in Clinical Trials for Cannabinoids

In 1985 the FDA approved the first use of cannabinoid extracts, Dronabinal and Nabilone, for purposes of managing chemotherapy-induced nausea and vomiting, as well as AIDS-related anorexia and wasting.

The FDA has since granted orphan drug designation to an oral liquid formulation of the plant-derived cannabidiol (Epidolex) for clinical testing to treat Dravet syndrome, Lennox-Gastaut syndrome, and neonatal hypoxischemeic encephalopathy.

A recent presentation stated, Epidolex in doses up to 25 mg/kg, reduced seizure frequencies in multiple drug-resistant epilepsy syndromes and seizure types. Other cannaboids such as Nabiximol (Sativex) have been designated in the “fast track” of clinical trials reaching phase 3 for advanced cancer pain treatment. Several cannabinoids have also demonstrated effectiveness or probable effectiveness for spasticity, central pain, and painful spasms in multiple sclerosis (ms). Cannabinoids are paving the way for successful clinical testing of marijuana and its extracts. The table below presents the legal status of some of the most prevalent cannabinoids in the United States.


Table 1 (Cannabinoid formulations):

Generic (trade name) Constituents US FDA approval Legal under federal/state laws
Marijuana THC*, CBD*, multiple other components No No/yes (select states)
Dronabinol (Marinol) THC in tablet form Yes Yes/yes
Nabilone (Cesamet) Synthetic cannabinoid in tablet form Yes Yes/yes
Nabiximols (Sativex) Oromuscosal spray mixture of THC and CBD No No/no

*The primary psychoactive chemical property of the Marijuana plant is delta-9-tetrahydrocannbinol (THC). The second most prevalent chemical is cannabidiol (CBD) which has no significant psychoactive effects.


Challenges and Limitations in Generating Sounded Evidence on Medicinal Cannabis Treatment

Further scientific proof must be established to better understand the effectiveness of cannabinoids in treating neurology related illnesses. Most scientific inquiries on this issue have been performed via surveys, case reports, or non-placebo-controlled studies – all of which significantly rely on subjective measures of patient reporting. Although patient perception is a key factor in determining marijuana efficacy, scientific studies could benefit from more objective measures.

Medical marijuana is available in many forms with each having a different method in administration. Oral extract formulations are standardized and produced by pharmaceutical companies in the US. Other preparations of medicinal marijuana such as smoking, vaporizing, and ingesting are yet to become standardized and vary greatly in the dosage delivery of THC and CBD. The further development of expertly designed clinical trials will facilitate more knowledgeable information on the effects of various types of medicinal marijuana. This will allow for safer prescriptions and fuller comprehension on both the positive and negative effects of medicinal marijuana consumption.


A Growing Chorus for Medicinal Marijuana

Schedule I designation impedes the rigorous systematic process necessary to determine further medicinal uses of marijuana within the United States. Federal legislation to reclassify marijuana as a schedule II drug would catalyze the pace and quality of scientific studies on medical marijuana.

The American Medical Association, the institute of Medicine, and the American College of Physicians are calling for the reclassification of marijuana as a schedule II drug. The American Academy of Neurology is the latest medical institution to join the chorus of prominent institutions requesting reclassification of marijuana to enable scientist to perform institutional review board-approved research.

The winds are favorable for medicinal marijuana as clinical traction backed by the FDA approval occurs within the Neurology field. The growing body of empirical research is reinforcing the medicinal efficacy of marijuana, consequently outdating the schedule I classification of cannabis. As these trends continue, keep abreast on how insurance companies will adapt.

Photo credit: Huffington Post