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Could this cannabis-based medication receive FDA approval?

Clinical trials on marijuana-based epilepsy treatment Epidiolex have produced positive findings. The Utah study is the latest success for the medication, which is set for FDA approval in the near future after passing Phase III tests. Excitement has built around Epidiolex, with children suffering from treatment-resistant epileptic conditions such as Dravet’s expected to be the biggest beneficiaries.

Study touts effectiveness of Epidiolex as epilepsy treatment

The University of Utah’s Division of Pediatric Neurology has been investigating the medical potential of CBD-based treatments for more than three years – the findings are overwhelmingly positive. The latest study, which remains ongoing, has so far found that two-fifths of participants have experienced a reduction in the severity and frequency of epileptic seizures.

The study concentrates mainly on young adults and children with debilitating epilepsy, with around 30 Utahan patients taking part as of 2017. GW Pharmaceuticals are the brains behind Epidiolex, and investors are taking the notice – their stock more than doubled in value when the Phase III clinical trials results were released.

GW Pharmaceuticals and the FDA

Existing medication is failing patients with severe forms of epilepsy (i.e. Dravet’s). Patients can be afflicted with more than 100 seizures per week, which can be life-threatening – they also significantly affect quality of life. Therefore, the federal government and the FDA have taken a softer stance toward Epidiolex than they usually would for marijuana, which continues to be federally prohibited. Indeed, the GW Pharmaceuticals product has been given Orphan Drug Status.

As defined by the FDA, drugs included in the Orphan Drug Designation program are deemed to have the potential to safely and effectively treat or prevent rare diseases or disorders. For a drug to be eligible, fewer than 200,000 Americans must be affected by the disease it targets. If it’s for more than 200,000 people, the drug can only make the program if it’s not viable to otherwise finance its development or marketing.

This program has been extremely useful for rare diseases, and more than 400 drugs and biologic medicines have made it onto the market since it started in 1983. In the decade prior to the Orphan Drug Designation program, fewer than 10 products were successfully developed and put onto the market.

The facts support CBD medication for epilepsy patients

Now that Utah’s Primary Children’s Hospital’s research – in addition to other clinical trials – has come back favorably, GW Pharmaceuticals is due for another meeting with the FDA to try and secure the approval of its Epidiolex product.

The Primary Children’s Hospital has a national and worldwide reputation for its supreme healthcare services. The world-class doctors and equipment at the Utah institution allow for innovative research which is sought after by medical professionals from all parts. Simply put, when the Primary Children’s Hospital conducts research, experts take notice.

GW Pharmaceuticals and marijuana-based medication

Epidiolex is a 98-percent CBD liquid that contains negligible levels of other cannabinoids and no psychoactive THC. The bottled solution is fairly viscous and is applied using a syringe dropper.

The famous Sativex, a CBD-THC medication which has been uniquely approved by British regulators and others, is also manufactured by GW Pharmaceuticals. The sublingual, under-the-tongue spray is prescribed for Multiple Sclerosis symptoms, with its anticonvulsant and analgesic qualities treating muscle spasms and pain respectively. Sativex has a 1:1 ratio of CBD to THC – the latter is the psychoactive compound in cannabis that gets a user high.

Plans for Sativex to be approved by the FDA have faced tougher opposition, with the THC content of the spray proving a stumbling block. GW Pharmaceuticals is hopeful given that the FDA has previously approved Marinol, a product with synthetic THC. Both Sativex and Epidiolex are made using extracts from marijuana.

If given the choice, would you prefer natural or synthetic cannabinoids to treat your ailments? Are you currently using marijuana products as medication? Join the conversation by leaving a comment.

1 thought on “Could this cannabis-based medication receive FDA approval?

  1. I suffer from such severe back pain and neuropathy in many parts of my body that I cannot sit and must lie down all day and night. I have MS type movements though testing shows I have no auto-immune diseases.
    NSAIDs cause internal bleeding and I have tolerance to opiates.
    I cannot smoke due to damage done from lifetime of cigarettes.
    Marijuana creams help me but getting it
    Is very difficult for me. Can’t order online. Can’t drive.
    To be free of pain even for hours would be miraculous and so I seek Sativex.
    Please make this medication legal and
    Available to people like me.

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