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Will FDA’s Endorsement of CBD-based Drugs Spur Cannabidiol Sales?

01-18-2019 03:04 PM CET | Advertising, Media Consulting, Marketing Research

Press release from: Fact.MR

Will FDA’s Endorsement of CBD-based Drugs Spur Cannabidiol

The cannabidiol marketplace is likely to witness significant R&D investment in the pharmaceutical industry as a broad-spectrum pharmaceutical therapeutics. Multiple scientific studies have shown promising results of cannabidiol for its potential in the treatment of a number of diseases. Following which the cannabidiol market is marked by a considerable cannabidiol therapeutics getting FDA approval or moving ahead in the human clinical trials. For instance, INSYS Therapeutics, Inc. announced in March 2018, the initiation of Phase III clinical trial of cannabidiol oral solution for the treatment of a rare type of pediatric epilepsy, infantile spasms. GW Pharmaceutical plc and Greenwich Biosciences, GW’s subsidiary announced FDA’s approval of EPIDIOLEX® cannabidiol oral solution in June 2018 and from November 2018, the plant-derived cannabidiol is available by prescription in the U.S.

Approval of EPIDIOLEX® cannabidiol has become a landmark announcement as it is FDA’s very first approval of the drug derived from cannabis sativa plant and also validated some of the therapeutic benefits of cannabidiol. Further, the approval is expected to impact significant economic, political and legislative shifts across the global cannabinoid marketplace. Also, the Drug Enforcement Administration (DEA) is also expected to reschedule and change the classification of cannabidiol compound in the near future.

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Increasing CBD Sales: Regulatory Changes Regarding Industrial Hemp to Reduce THC Content & Cost of CBD

Cannabidiol (CBD) is a non-intoxicating and non-psychotropic cannabinoid, which not only imparts myriad beneficial health effects, but also is deprived of relevant side effects. CBD is industrial hemp’s primary cannabinoid, present in concentrations between the range 0.5% and 4%. Major stakeholders in the hemp industry have been focusing on continued growth, in tandem with progress being made in legislature and product development.

The Industrial Hemp Regulations (IHR) address specific topics apropos of the production, processing, control, and export measures within various stages of the industry. Current IHR require two conformances namely, tetrahydrocannabinol (THC) testing of every field, except cultivars depicting low THC in provided province, and THC sampling & testing in production process concerning food derivatives. These process are expensive and entail the need for significant administrative investments by health regulatory bodies.

Recognizing the concern, the Canadian Hemp Trade Alliance (CHTA) proposed an efficient infield science-based alternative for generating reliable results. The proposal involves elimination of THC testing with respect to food derivatives. The alterations suggested are expected to aid achieving the objective of reducing THC content in crops with relatively less investment. Such regulatory changes are further expected to facilitate harvest, processing, and sales of non-psychoactive cannabinoids such as CBD from industrial hemp.

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Improving Accessibility to CBD-based Therapies: WHO Report aids Alleviation of Restrictions on Cannabidiol

Cannabis comprises over 100 chemical compounds known as cannabinoids, with the most common among them being CBD and THC. The WHO’s Expert Committee on Drug Dependence (ECDD) published a report in 2017, which acknowledges clinical employment of CBD to be the most advanced treatment of epilepsy.

CBD is perceived to have significant therapeutic value for seizures on account of epilepsy and relevant conditions. In addition, clinical trials conducted on CBD have depicted its efficacy in treatment of various forms of epilepsy. The report further acknowledged existence of primary evidence underpinning utilization of CBD in treatment and management of various other diseases that include Alzheimer’s disease, multiple sclerosis, Parkinson’s disease, rheumatoid arthritis, Crohn’s disease and Huntington’s disease.

ECDD’s conclusion states that current state of research with regard to scheduling of CBD is not justified, and it could impact accessibility for medical and scientific research. ECDD’s impending final recommendations, to be published soon, will reaffirm or reinforce these conclusions, in order to alleviate legitimate basis for Secretary of Department of Health in maintaining present restrictions on CBD. This will not only relieve burden from companies developing medicinal products, but also improve access for consumers to effective and novel therapies.

Cannabidiol Market: Surging Penetration in Health Food Products

Rich in alpha-linoleic, linoleic, and antioxidants, CBD oil illustrates optimal ratio of Omega-6 and Omega-3 fatty acids. Numerous studies underpin the fact that properties of CBD assist management of depression & anxiety, pain, seizures, and insomnia. As researchers continue to analyze this increasingly popular cannabinoid, consumers across the globe are becoming more aware of the therapeutic qualities associated with CBD.

Based on preferences, circumstances, and conditions of an individual, there are various ways in which CBD can be consumed, with some of the valid options being vaping CBD oil, applying CBD ointment topically, and swallowing CBD capsules. Currently, more and more individuals are seeking incorporation of CBD into their lifestyle through infusion into their meals.

CBD-infused food products are gaining high momentum in the market, abreast growing consumer demand for healthy food options. In response to growing demand, companies are concentrating on production of healthy foods for meeting requirements of consumers seeking healthy replacements for traditional CBD-infused foods. Some of the common examples of such healthy alternatives include essential oil blends, flavored tinctures, and edibles such as coffee and candy.

Notable Developments in CBD Market

Pivot Pharmaceuticals Inc., in coordination with SolMic GmbH, its German technology partner, announced the initiation of its development of PGS-N001 in 2017. PGS-N001 is a water-soluble, natural, and pure oral CBD solution, which shows highest bioavailability and is devoid of THC. PGS-N001 will be developed and formulated for treating a wide range of disease indications such as the chemotherapy-induced nausea and vomiting (CINV) – major therapeutic challenge in cancer supportive care area.
Nightfood Holdings, a startup that manufactures and markets products in nighttime snacking category, entered into a joint venture with Player’s Network Inc. in 2017. This joint venture is dedicated toward the development of CBD-infused line of products such as cannabinoid oil.
Marijuana Company of America, Inc. (MCOA) has partnered with HoneyB Healthy Living for developing a series of CBD-based products. These products will be launched under the brand name “BeniHemp” and are intended to be distributed through convenience stores. The partnership aims at full-scale launch of their new product series by 2018-end, while coordinating supply chain arrangements via their partners in Colorado.

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About US
Fact.MR is a fast-growing market research firm that offers the most comprehensive suite of syndicated and customized market research reports. We believe transformative intelligence can educate and inspire businesses to make smarter decisions. We know the limitations of the one-size-fits-all approach; that’s why we publish multi-industry global, regional, and country-specific research reports.

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