author: Kevin Curran PhD

published: 7-6-2020

The health benefits of medicinal plants should not be broadly dismissed.

I often hear the claim, if the plant had health benefits then it would already be an approved drug.

The truth is – there are many reasons why a plant may not currently be approved as a drug in the US.

One of the biggest hurdles is the expense of drug approval. Pushing a drug through the FDA pipeline requires somewhere between 500 million to 3 billion in up-front costs.¹ Who can afford that?

On top of the cash, there is the risk. The vast majority (over 80%) of drugs that enter the decade long clinical pipeline will fail to demonstrate effectiveness. A late-stage, pipeline failure can bankrupt everyone involved.

Why am I talking about all this?

Good question.

A full spectrum cannabis extract (called nabiximols) is now on a clear trajectory to receive FDA approval as a drug in the near future.² A pharma company has recently initiated five separate, late-stage clinical trials with the intention of securing FDA approval in the US.

According to investment analysts, the chances of FDA approval based on these trials is highly likely.

If approved, what would this drug treat?

It would treat muscle stiffness and muscle tension associated with multiple sclerosis and spinal cord injury. That’s not all, this same company is pursuing clinical trials with nabiximols for anxiety, sleep disturbance and irritability in patients with post traumatic stress disorder (PTSD). The company forecasts $800 million annual revenue based solely on usage in multiple sclerosis and spinal cord injury patients. If approved, I think it is highly likely the drug will be prescribed in much broader contexts than those just mentioned. Nabiximols may be prescribed in a similar context as baclofen, a commonly used muscle relaxant.

What exactly is this drug?

Nabiximols is formulated from an extract of the cannabis plant. This extract contains THC and CBD, other cannabinoids, terpenes, etc. Patients would take the drug through a mouth spray. Each spray delivers a consistent dose of 2.5 mg CBD and 2.7 mg THC. 5

So… basically this drug is a proprietary cannabis extract that is delivered to the mouth?

Yes that is correct.

You would be forgiven if you asked how nabiximol is different than a full spectrum hemp oil, which you can currently purchase online. In my opinion, they are similar but not identical. The exact ratio of plant chemicals will be different, but both items are extracts from the same plant, Cannabis sativa.

I’m not surprised this pharma company is relying on a full spectrum cannabis extract for their clinical trials. Previous studies suggest that consuming the whole plant is more beneficial than a single isolated chemical. 4

So…. to tie this all together. Sometimes a plant does contain healing properties. Sometimes you do need the full plant extract to sufficiently capture health benefit.

Sometimes a plant is used for decades, centuries, millennia…before a group finally puts together the cash and risk strategy to pursue a clinical drug approval.

Fortunately, when congress passed the 2018 Farm Bill, they made hemp and hemp derived products legal at the federal level. Full spectrum hemp contains less than 0.3% THC (the federal legal limit), therefore it’s legal to sell online and ship to all 50 states. 6,7

The link below is for an article I wrote to help educate people about legitimate, full spectrum hemp or CBD oil.

The EthnoHerbalist guide to finding a quality, full spectrum hemp extract.

References:

    1. Tufts study on the cost of FDA drug approval. 
    2. Recent press release on upcoming clinical trials for nabiximols
    3. Recent nabiximols trial data showing effect on spasticity and pain
    4. Russo paper summarizing the benefits of whole cannabis plant extract
    5. GW Pharma June, 30 2020 investor relations presentation on nabiximols
    6. Legal to ship hemp and CBD to all 50 states
    7. A deep dive into the 2018 Farm Bill