New CBD drug starts phase 2 clinical trials


Zynerba Pharmaceuticals, a pharmaceutical company based in the US, is currently preparing a phase 2 clinical trial program for its most recent CBD-derived drug, Zygel.

Zygel is a transdermal gel (a gel that is applied to the skin and then absorbed into the bloodstream) developed to treat the symptoms of a condition called “Fragile X Syndrome” (FXS). This is a very rare genetic disorder where the subjects display intellectual disabilities (on average, individuals can have IQ scores under 55), distinct physical features, seizures, hyperactivity, and even autism-related symptoms, like weak social interaction abilities and delayed speech. There is no cure for this condition, and the currently available treatments include medication to treat physical symptoms, as well as physical, speech, and behavioral therapies.

This gel developed by Zynerba contains a synthetic type of CBD called 8,9-dihydrocannabidiol (H2CBD). The researchers specifically designed it to be able to efficiently cross the skin barrier and enter the bloodstream in high enough amounts to have an acceptable therapeutic effect.

In fact, and according to the pharmaceutical company, this new CBD-based gel can solve many of the issues and limitations which are typically seen in these types of treatments:

  • As a transdermal gel, and contrary to what happens with oral medication, it does not pass through the gastrointestinal system and is not metabolized by the liver before entering the blood (thus being available in the bloodstream in higher amounts), does not cause gastrointestinal side effects (such as nausea, vomiting, and diarrhea), and minimizes the risk of drug-drug interactions;
  • The fact that it’s directly absorbed into the bloodstream allows the researchers to use fewer quantities of pharmaceutical ingredients to achieve the expected therapeutic effects;
  • The synthetic CBD present in the gel was previously enhanced and is therefore highly absorbable through the skin;
  • The fact that the CBD is not ingested avoids its transformation into THC that can occur in the stomach, therefore decreasing the risk of psychoactive side effects;
  • Being fully synthetic, the manufacturing process of CBD does not require extracting components from the cannabis plant, therefore lowering the development and manufacturing costs (since it’s not necessary to grow and harvest the plant).

The clinical trials are being conducted at the moment, and the company is still looking for new participants. These trials are expected to last around 14 weeks and will include 240 FXS patients (ages 3 to 17) at approximately 20 clinical sites in the US, Australia, and New Zealand. 

Other than FXS, the company expects this gel to also be applicable to treatment in patients (mostly children) with autism, 22q Deletion Syndrome and Developmental and Epileptic Encephalopathies.

And the list of good news isn’t over yet. Since Zygel is designed to meet very important medical needs regarding these rare and serious conditions, it has already received the Fast Track Designation from the US Food and Drug Administration agency (FDA). This means that the product can receive an expedited review from the FDA and is therefore susceptible to receiving earlier approval and access by all patients who need it.

CBD is known for its beneficial neuroprotective, anti-inflammatory, anti-seizure, anti-bacterial, analgesic, anti-anxiety, mood-stabilizing, and antipsychotic effects, among others, without yielding undesired psychoactive effects. Now, the research and development of this new drug evidences yet another positive use that CBD can have in current medical treatments.

Moreover, H2CBD, the synthetic CBD contained in Zygel, was already demonstrated to have anti-seizure properties, and has a few additional very positive traits:

  • It can be used without being subjected to anti-cannabis regulations;
  • It doesn’t incur the risk of contamination by pesticides or other chemicals used during cannabis cultivation;
  • It can’t be chemically transformed into THC;
  • It eliminates the need to cultivate, process, or import cannabis plants.

If the trials are successful, we are about to witness a very important development in modern medicine that can truly help patients suffering from rare disorders which are usually very difficult to treat and, as far we know, impossible to cure.


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