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Zygel TM (ZYN002 CBD Gel)

Zygel is the first and only pharmaceutically-produced CBD, a non-euphoric cannabinoid, formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. Zygel is being developed for patients suffering from FXS, ASD in pediatric patients, 22q, and a heterogeneous group of rare and ultra-rare epilepsies known as developmental and epileptic encephalopathies (DEE).

Zygel is an experimental treatment. This means that it is not approved by government regulatory bodies, including the United States Food and Drug Administration (FDA) and other agencies and must be tested to see if it is an effective and safe treatment.

Addressing Limitations of Current Treatments

Challenge: Oral administration

Oral administration can lead to limitations in safety and efficacy including gastrointestinal side effects like nausea, vomiting and diarrhea, low bioavailability, inconsistent plasma levels and significant first-pass liver metabolism. First-pass liver metabolism refers to the process by which the liver breaks down drugs ingested directly or indirectly through the gastrointestinal system, such as through oral or oral-mucosal delivery methods, allowing only a small amount of drug to be absorbed into the circulatory system.

Potential Benefit of Zygel:
Zygel is a unique permeation-enhanced CBD transdermal gel. Transdermal therapeutics are applied locally and absorbed through the skin directly into the systemic circulation, resulting in a lower incidence of gastrointestinal side effects, and avoidance of first-pass liver metabolism, which potentially enables lower dosage levels of active pharmaceutical ingredients and rapid, reliable absorption with increased bioavailability. Other potential benefits of transdermal delivery compared with oral administration may include fewer drug-drug interactions.

Challenge: Topical Administration

CBD and other cannabinoids are large, complex molecules that do not penetrate the skin efficiently without the use of technologies that improve their penetration. As such, topical formulations of CBD or oils derived from Cannabis may require very high doses to reach therapeutic blood levels, or may not cross the skin and into the bloodstream at all.

Potential Benefit of Zygel:
Zygel is a proprietary pharmaceutically-manufactured CBD gel formulated with permeation enhancers, which improve the ability of CBD to cross through the skin and into the bloodstream when administered directly to the skin (transdermal delivery).

Challenge: CBD degradation to THC in the stomach

An in vitro (performed in a lab in a test tube, culture dish, or elsewhere outside of a living organism) study, titled “Identification of Psychoactive Degradants of Cannabidiol in Simulated Gastric and Physiological Fluid,” which was conducted by Zynerba and published in April 2016, demonstrated that CBD is degraded to THC in an acidic environment such as the stomach. THC is the principal psychoactive cannabinoid. As such, we believe that degradation of CBD into THC may lead to increased negative psychoactive effects.

Potential Benefit of Zygel:
Transdermal delivery of Zygel avoids the gastrointestinal tract and potential degradation to THC in stomach acid, which should minimize the risk of negative psychoactive effects.

Challenge: Botanically derived cannabinoids

Botanical cannabinoids may create significant challenges for drug manufacturers because of the natural resources and security measures required to grow and harvest Cannabis .

Potential Benefit of Zygel:
Zygel is pharmaceutically manufactured in a cGMP (Current Good Manufacturing Practice) facility that will comply with rigorous efficacy and safety standards established by global regulatory agencies and is not extracted from the Cannabis plant. We believe that producing CBD this way ensures that we can provide consistent potency and efficiently scale manufacturing to meet the needs of the markets that we are targeting, without the cost and logistical requirements of growing and harvesting Cannabis .

Zygel: Permeation-Enhanced Gel

Zygel is a pharmaceutically-produced CBD formulated as a permeation-enhanced gel for transdermal delivery.

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Zygel TM (ZYN002 CBD Gel) Zygel is the first and only pharmaceutically-produced CBD, a non-euphoric cannabinoid, formulated as a patent-protected permeation-enhanced gel for transdermal

Cannabis Pharmaceuticals Market: Rise in investments by pharma companies in CBD to drive the market

Published: Nov 01, 2020

Cannabis Pharmaceuticals Market: Overview

Cannabis-based products or the medical marijuana has orchestrated new avenues in the pharmaceuticals industry. Pharma companies, small and big, have plowed investments in cannabidiol (CBD), particularly. The inroad made by CBD and CBD-based products is unarguably daunting, riding on the wave of staggered legalization of marijuana. The game-changing potential that cannabis has made pharma companies nurse new aspirations by setting their sights in the cannabis pharmaceuticals market.

Unsurprisingly, some pharma companies for instance, Insys Therapeutics, put robust opposition to legalization of marijuana. The regulatory status on the CBD is markedly unclear and lack worldwide consensus, for instance, differs from state to state in the U.S., and from nation to nation. Nonetheless, over the years there is a clear surge in interest of pharma companies in medical marijuana, given the medical conditions where cannabis hold incredible potential.

FDA-approved CBD-based drugs will stridently see an increase, expanding the horizon in the CBD market. One of the most recalcitrant diseases CBD-based products in cannabis pharmaceuticals market hold potential, as body of preclinical studies have reiterated, is Dravet syndrome and Lennox-Gastaut syndrome (LGS).

A new study on the cannabis pharmaceuticals market scrutinizes the investment potential of some of the aforementioned trends and the ways in which those will shape the growth dynamics during 2020 – 2030.

Cannabis Pharmaceuticals Market: Key Trends

The shape of the cannabis pharmaceuticals market is expected to be molded by the changing dynamic of the regulatory landscape. A large part of negative public perception of cannabis products has been associated with the recreational use of TSH, a key psychoactive element of cannabis. However, as things have begun to change, the global medicinal industry will intensify its efforts in harnessing therapeutic benefits of cannabis.

The cannabis pharmaceutical industry will see new vistas opening up from expanding array of studies that will provide scientific backing of CBD. This is particularly in relation to the safety and uncontested claims of safety. Further, as regulators will treat different categories of cannabis-based product differently and suitably, the risk benefit profile of cannabis pharmaceuticals will become clearer. The scientific rigor for evidence-based medicine will expand the potential of the market and pave way for research in purified cannabidiol.

Two areas where the industry nurses tall hopes in the cannabis pharmaceuticals market are in reducing opioid epidemic, and in managing some of the hard-to-treat conditions such as some cancers. Stakeholders also appreciate the potential of medical cannabis for aesthetic and medical dermatology.

Cannabis Pharmaceuticals Market: Competitive Analysis and Key Developments

The cannabis pharmaceuticals market has seen numerous big shot companies testing new waters in medical marijuana, and making strategic moves to this end. Research units of a few top pharma companies have made moves toward commercializing cannabinoids for medical use. A recent example is research being made by Avicanna for Johnson & Johnson, and by Vapium for Grenco Science.

Another company, notably a spin-off of Abbott Laboratories, AbbVie Inc. has upped its cannabis-related patents. These developments will undoubtedly strengthen the pipeline of cannabis-related drugs, unlocking new prospects in the cannabis pharmaceuticals market. In the course of time, more start-up companies will ramp up their efforts in patenting Cannabis-based tablets and products.

Another behemoth that is making giant stride in the cannabis pharmaceuticals market is Teva Pharmaceuticals. The company recently announced formally that it has entered into distribution deal with cannabis company Canndoc.

Cannabis Pharmaceuticals Market: Regional Assessment

North America has seemed to garner incredible revenue potential among all key geographies in the cannabis pharmaceutical market over the past several years. The groundswell of interest in medical marijuana is circumscribed by favorable regulations in some quarters, notably in parts of the U.S. Intense discussion among industry stakeholders about the taxing and labelling of cannabis-based medicinal products will cement the potential of the regional market. They are keen on increasing the profitability of marijuana-based products. Another promising region is Europe, expanding on the back of rise in investments by pharma companies in CBD.

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