NIH: Teen Marijuana Use Not Increasing Despite Legalization

MARYLAND: Self-reported marijuana use by adolescents has failed to increase in recent years despite the majority of states legalizing it for either medical or adult use, according to the latest data compiled by the University of Michigan’s Monitoring the Future survey, which is commissioned by the US National Institutes on Drug Abuse. NIDA is a part of the US National Institutes of Health.

Summarizing the findings in a press release, the agency acknowledged: “Rates of marijuana use by teens have been of great interest to researchers over the past decade, given major social and legislative shifts around the drug; it is now legal for adult recreational use in 10 states plus the District of Columbia, and it is available medicinally in many more. Fortunately, even as teens’ attitudes toward marijuana’s harms continue to relax, they are not showing corresponding increases in marijuana use.”

Marijuana use prevalence by young people did not change significantly between 2017 and 2018, the survey reported. Between the years 2012 and 2018, both rates of lifetime marijuana use and rates of annual marijuana use by 8th, 10th, and 12th graders have declined. Ten states have enacted laws regulating adult marijuana use during this same period of time, and several others have legalized medical cannabis access.


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. Further data is available from NORML’s fact-sheet, “Marijuana Regulation and Teen Use Rates.”

 

Statement From FDA Commissioner Scott Gottlieb On Researching Medical Uses Of Cannabis

By Scott Gottlieb, MD

DISTRICT OF COLUMBIA: Over the past decade, we’ve seen a growing interest in the development of therapies derived from marijuana and its components. Proponents of “medical marijuana” advertised its uses for a wide number of medical conditions, such as cancer, multiple sclerosis, post-traumatic stress disorder and anxiety – just to name a few of the touted conditions. The FDA has been supportive of research in this area for many years. But marijuana is a Schedule I compound with known risks. Research to demonstrate that marijuana or its components could be safe and effective in the treatment of medical disorders should be held to the same standard as other drug compounds. And certainly it should not be held to a lower standard, as some proponents would suggest. The FDA has an active program to assist drug developers who want to investigate marijuana or its components through properly controlled clinical trials, to demonstrate the potential for safe and effective uses.

Today, the FDA approved a purified form of the drug cannabidiol (CBD). This is one of more than 80 active chemicals in marijuana. The new product was approved to treat seizures associated with two rare, severe forms of epilepsy in patients two years of age and older.

This product approval demonstrates that advancing sound scientific research to investigate ingredients derived from marijuana can lead to important therapies. This new treatment provides new options for patients.

This is an important medical advance. But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. Moreover, this is a purified form of CBD. It’s being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits. This is how sound medical science is advanced.

So today, in addition to celebrating this scientific achievement and the medical advance that it represents for these patients and their families, we should also reflect on the path that made this possible. It’s a path that’s available to other product developers who want to bring forth marijuana-derived products through appropriate drug development programs.

That pathway includes a robust clinical development program, along with careful review through the FDA’s drug approval process. This is the most appropriate way to bring these treatments to patients. This process also includes a review of the purity of a new drug and manufacturing controls. Before a high-quality drug can be developed, evaluated, and eventually approved by the FDA; it’s critical that the necessary work is done to identify drugs of potential medical benefit and conduct rigorous scientific research through adequate and well-controlled clinical trials. This is true for all drugs, including ones derived from plant materials, like marijuana. And the FDA remains committed to collaborating with federal and state agencies, researchers and product developers on advancing this type of important and conscientious work.

This research process – from early development through preclinical and clinical research – gives us a comprehensive understanding of a new drug. That includes an understanding of whether the new product is safe and effective for treating a particular medical condition, what the proper dosage is and for what populations it is safe and effective, how the new compound could interact with other drugs, or whether the new drug has side effects or other safety concerns.

This work also helps product developers identify the appropriate dosage needed to achieve the desired therapeutic effect while minimizing toxicity and risk. Taken in totality, the scientific evidence generated by these studies forms the basis of the FDA’s evaluation of benefit versus risk. And it’s because of this careful, scientific and evidence-based evaluation by the FDA that health care providers can rely on having a quality product that delivers a consistent, uniform dose of an effective medication that is able to deliver a predictable treatment to patients. This is especially important when considering treatment for serious medical conditions that will be utilized in the clinical care of patients who may have any number of health vulnerabilities. The purified form of the drug CBD approved today by the FDA has been shown to meet these rigorous standards.

Research on the therapeutic effects of marijuana and its components involves a number of federal agencies in addition to the FDA, including the National Institute on Drug Abuse, part of the National Institutes of Health, and the Drug Enforcement Administration.

MMJ International Holdings Pursuing Legal FDA Cannabis Medicine Approval

MMJ International Holdings Pursuing Legal FDA Cannabis Medicine Approval

The FDA has taken several specific steps to support this research.

We meet regularly with researchers as they plan and carry out their trials. We have also formed a Botanicals Team that provides scientific expertise on botanical issues for researchers developing drugs derived from plants, such as marijuana. That team published guidance for industry on clinical studies involving botanical drugs, as well as quality controls for lot-to-lot consistency. In recent years, the agency also has recommended to the DEA the approval of several hundred Schedule I research protocol licenses for research on marijuana or its constituent compounds.

Additionally, the FDA also works with companies to provide patients access to experimental therapies while clinical trials are ongoing through expanded access provisions. These approaches help protect patients while also allowing for the collection of data necessary to support the FDA approval of safe and effective therapies for use in the broader population. Through this process, hundreds of children were able to get access to investigational CBD products while this product was being studied.

Drugs derived from marijuana also are eligible for several programs that are intended to facilitate and expedite development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions. Much of the work we’ve done to encourage research in this area has led to the approval action we took today.

The FDA will continue to support rigorous scientific research on potential medical treatments using marijuana and its components that seek to be developed through the appropriate scientific channels. However, we remain concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims.

The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases. The FDA has taken recent actions against companies distributing unapproved CBD products. These products have been marketed in a variety of formulations, such as oil drops, capsules, syrups, teas, and topical lotions and creams. These companies have claimed that various CBD products could be used to treat or cure serious diseases such as cancer with no scientific evidence to support such claims. We’ll continue to take action when we see the illegal marketing of CBD-containing products with unproven medical claims. We’re especially concerned when these products are marketed for serious or life threatening diseases, where the illegal promotion of an unproven compound could discourage a patient from seeking other therapies that have proven benefits.

Today’s approval demonstrates our commitment to the scientific process and working with product developers to bring marijuana-based products to market. We remain committed to our gold standard for product development and review. Such a process ensures that any new therapies from marijuana and its constituents are safe, effective and manufactured to a high and consistent quality. And most importantly, that these products have been proven safe and effective for patients.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

Librede Inc. Awarded Highly Competitive Phase II SBIR Grant From NIH

CALIFORNIA: Librede, an early stage biotechnology company, has been awarded a $1,490,000 Phase II Small Business Innovative Research Grant (SBIR) from the National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health (NIH), to further develop and scale their proprietary yeast-based cannabinoid production platform.

The NIH SBIR program is a highly competitive program aimed at translating cutting edge research with large societal, health, and economic benefits into commercial products. This new grant follows the successful completion of a previous Phase I SBIR award granted to Librede by NIH, covering development of complete biosynthesis of cannabidiol (CBD) in yeast. This platform technology has been patented by Librede (Patent # 9,822,384) and will serve as the basis of an industrial scale pharmaceutical cannabinoid production system.

In the new Phase II award, Librede will improve titers and scale the technology in large bioreactors. Dr. Anthony Farina, Librede’s Chief Scientific Officer (CSO) and Principal Investigator of the new Phase II award, explains Librede’s technology and current focus, “By harnessing the power of genetic, metabolic and protein engineering, we have developed a highly robust system to produce the valuable therapeutics found in the cannabis plant. We have successfully demonstrated the production of CBD in yeast from low cost feedstocks such as sugar. The CBD produced in our system is identical to agriculturally produced CBD, but our system is more efficient and better controlled. Now we will begin to scale our technology. This is the last technical step that must be addressed before we can move into production and provide high quality, pharmaceutical grade cannabinoids.”

Cannabidiol (CBD) is one of many cannabinoids that are currently being explored as therapeutic agents for a wide range of diseases. As new uses for these compounds are discovered, the market for cannabinoids will continue to rise globally, with many estimates placing the market size in excess of $50B in 2020, with that of CBD alone being $2.1B. As the market rapidly expands, this industry will require innovation that can increase volume, reduce costs, and improve the quality of these therapeutic compounds. Librede’s fermentation platform has the ability to meet this demand.

Dr. Jason Poulos, Chief Executive Officer (CEO) of Librede explains, “Other industries have turned to biotechnology to source high value ingredients in an environmentally and economically sustainable way. Here at Librede we are taking a similar approach to the large scale production of cannabinoids. Agricultural production is high in cost and not environmentally sustainable requiring large amounts of land, water, labor, pesticides, fertilizers, and energy. By utilizing a different manufacturing approach, production is faster, lower in cost, and uses less water, less land, and less electricity, while requiring no fertilizers or pesticides. Although our initial focus is CBD production, development of this technology is also applicable to production of other cannabinoids.”

OWC Pharmaceutical To Begin Testing On Cannabinoid-Infused Psoriasis Cream

ISRAEL: OWC Pharmaceutical Research Corp., an Israeli-based developer of cannabinoid-based therapies targeting a variety of different medical conditions and disorders, announced it has received Institutional Review Board (IRB) approval to conduct safety testing on its proprietary topical crème compound for the treatment of psoriasis and related skin conditions. The approval follows the Company’s February 1, 2017 8K filing announcing an extension to the size and scope of its efficacy study on the same compound, which began in November 2016.

The IRB approved study encompasses the cream itself, as a delivery mechanism, as well as the proprietary psoriasis formulation, and is the first to formally make such claims with the NIH Registry. The double-blind study, which will be conducted on healthy volunteers at one of Israel’s leading academic hospitals, is designed to demonstrate the safety of the formulation in treating psoriasis on human skin tissue. Administrators began soliciting for study participants as soon as approval was received.

Dr. Yehuda Baruch, the Company’s Director of Research and Regulatory Affairs, commented on the announcement, “This approval is a significant milestone for OWC, where our mission is to bring the same rigorous approach common to traditional pharmaceutical development to the medical cannabis field. As we reported earlier this year, the results of our efficacy studies were so encouraging that management decided it was in our interest to extend the size and scope of the study to check the biological markers that had been generated to date, among other things. “

Dr. Baruch went on to say, “With each study we conduct, the ability of our formulation to provide relief for psoriasis-related symptoms to patients suffering from the condition are substantiated. The study that was just approved was designed to assure patients and caregivers that it is safe to use outside of laboratory conditions.”

Ziv Turner, OWC’s Vice President of Business Development and Managing Director of One World Cannabis, Ltd., the Company’s wholly-owned subsidiary, went on to say, “As soon as we announced the formulation of our psoriasis treatment we began receiving requests for the product from patients suffering from the condition. After many years of research and development, this is the final study as we prepare to introduce it to the market. We expect to the program will be in full swing by the end of the month and hope to have it completed by during the second quarter of 2017, and in the hands of patients shortly thereafter.”

Psoriasis is an autoimmune disease that causes red, scaly patches to appear on the skin, and can be associated with other serious health conditions, including diabetes, heart disease and depression. Skin cells in patients with psoriasis grow at an abnormally fast rate, causing a buildup of lesions that tend to burn and itch. While the real cause of psoriasis is not known, genetics are believed to play a major role in its development. According to the National Psoriasis Foundation, psoriasis affects 7.5 million people in the United States.

Librede Awarded NIH Funding to Optimize Cannabinoid Production in Yeast

CALIFORNIA: Librede, a San Diego-based synthetic biology company, has received a Phase I Small Business Innovative Research (SBIR) Grant from the National Institute of General Medical Sciences (NIGMS), part of the National Institutes of Health (NIH), to improve Cannabidiol production in genetically engineered yeast.

Cannabidiol (CBD) is one of several pharmacologically active chemicals (cannabinoids) found in the cannabis plant and has been shown to be useful in treating a wide range of diseases including childhood epilepsy. Librede recently completed another NIH Phase I SBIR to engineer production of CBD from sugar; Librede’s new award will improve the yield of CBD production in preparation for commercial launch. Dr. Anthony Farina, Librede’s Chief Scientific Officer, explains, “Our pioneering work producing cannabinoids in yeast has given us a number of insights into the redirection of yeast metabolism for CBD production. During this NIH award, our team will implement these insights to improve production efficiency of our current CBD-yeast system. High throughput techniques and new gene editing tools allow us to make a large number of modifications and screen them for performance rapidly and inexpensively.”

Although the therapeutic value of many cannabinoids is well recognized, their primary source is the cannabis plant, which produces most of the 70+ cannabinoids in very low amounts, requiring problematic large scale agricultural production. Dr. Jason Poulos, Chief Executive Officer of Librede, explains: “As demand for cannabinoids increases we must find an environmentally and economically sustainable way for their production. Large scale agricultural production is environmentally destructive, requiring huge amounts of land, water, fertilizers, pesticide and energy. Our yeast-based system is superior to agricultural production with respect to all of these areas.”

Although the focus of this award is on CBD, Librede’s platform is capable of making many different cannabinoids. “It is straightforward to modify the engineered yeast to produce a number of different cannabinoids,” said Dr. Farina. “Many of these cannabinoids are produced in plants at such low levels that it is infeasible to produce them agriculturally. We are very excited to expand the range of cannabinoids produced for use in pharmaceutical studies.”

 

 

How Much Does Marijuana Impact Your Driving?

DISTRICT OF COLUMBIA: A rigorous federal research study by the National Institute on Drug Abuse offers new data on the effects of marijuana on driving performance.

The exact impact of marijuana on driving ability is a controversial subject—and it’s become more important states continue to loosen their drug laws. And, while drunk driving is on the decline in the U.S., driving after having smoked or otherwise consumer marijuana has become more common. According to the most recent national roadside survey from the National Highway Traffic Safety Administration of weekend nighttime drivers, 8.3 percent had some alcohol in their system and 12.6 percent tested positive for THC—up from 8.6 percent in 2007.

It is illegal in all states to drive under the influence of anything, but years of work went in to establishing the .08 breathe alcohol limit that exists in most states. The question is whether we can establish a similar threshold for pot.

Cannabis Proves Effective In Treating Crohn’s Disease According To New Study

TEXAS:  A new clinical study published in the journal Pharmacology and by the National Institute of Health has found that cannabis is effective in treating Crohn’s disease, which is a form of inflammatory bowel disease (IBD).

IBDs such as ulcerative colitis and Crohn’s affect over a million people in the United States. Many IBD victims suffer from pain, diarrhea and poor ability to digest food, and up to half of IBD cases are so severe that they ultimately require surgery to remove the affected bowel segment. [Read more…]