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On this month’s episode, we are joined by Nathan Johnson, PhD, the Co-Founder and CEO of VERNE Bioanalytics

Ep 15: Hot Topics in Cannabis Cultivation—Hop Latent Viroid, Genetics, and More

 Breaking the Reins: How One Mustang Found a Second Chance with CBD

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Cannabis Patient Care November/December

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Cannabis Patient Care October

In early April 2023, three companies announced their joint efforts to pursue approval from the Food and Drug Administration (FDA) for a new botanical drug to target a neurological condition (1). The two Colorado-based hemp companies are Charlotte’s Web, a cannabidiol (CBD) and hemp extract wellness products company, along with AJNA BioSciences PBC, a botanical drug development company focused on natural pharmaceuticals that address mental health and neurological disorders (1). The third company, British American Tobacco (BAT) is an international company that manufactures and sells nicotine products (1).

“The JV [joint venture] was established to pursue FDA-approval for a novel botanical drug to target a neurological condition identified by the JV leadership team, which will be comprised of CW, AJNA, and BAT representatives…The JV plans to engage with the FDA to file an Investigational New Drug (IND) application and commence Phase I clinical development in 2023,” stated the press release (1). Charlotte’s Web and AJNA each hold 40% in the venture, the drug will contain hemp genetics from Charlotte’s Web, and AJNA will provide laboratory, regulatory services, and clinical expertise. (2).

Leading the clinical and regulatory strategy is AJNA's Chief Medical Advisor, Orrin Devinsky, MD, PhD. Dr. Devinsky is the Director of New York University (NYU) Langone's Comprehensive Epilepsy Center and was a principal investigator for the development of Epidiolex (1). "As one of the first clinicians to research novel cannabinoids, I am very excited to work on this project. I believe the properties of cannabis and hemp are well suited for the FDA's new Botanical Drug Development pathway,” Dr. Devinsky said (1).

"This joint venture is a capital efficient way for Charlotte's Web to unlock the value of its intellectual property to advance development of effective botanical alternatives to current neurological pharmaceuticals," said Jacques Tortoroli, CEO of Charlotte's Web (1).

"Our investment in the Joint Venture reinforces our commitment to Charlotte's Web and represents another step for BAT in our exploration beyond tobacco and nicotine,” said James Barrett, Commercial Director of Wellbeing and Stimulation at BAT (1). BAT had also invested in Charlotte’s Web in November 2022 (3).

https://www.prnewswire.com/news-releases/charlottes-web-forms-joint-venture-with-bat-and-ajna-biosciences-to-seek-fda-approval-for-proprietary-full-spectrum-hemp-extract-botanical-drug-301791858.html

https://hemptoday.net/bat-invests-10-million-in-u-s-venture-to-develop-hemp-drug/

https://www.bat.com/group/sites/UK__9D9KCY.nsf/vwPagesWebLive/DOCL6PSP

Articles

Two Colorado-based hemp companies and one tobacco company are joining forces to pursue FDA-approval for a new botanical drug.

Charlotte's Web, AJNA BioSciences, and British American Tobacco Form Joint Venture for FDA-Approval of New Botanical Drug

Madeline Colli is the Associate Editor for Cannabis Patient Care and Cannabis Science and Technology magazines at MJH Life Sciences.

In March 2023, the House Health Care and Wellness Committee amended and approved a psilocybin bill in a bipartisan 13-4 voice vote. The amendment was brought forward by Representative, Nicole Macri (D). “The bill as it stands takes very thoughtful steps towards a way that we as a state can consider a regulatory framework,” Macri mentioned before the vote started (1). “I like that the advisory group will come back with recommendations to the legislature next session and that, with this pilot that we have added to it, can gain more insight into the applicability of this service.”

The bill is called SB 5263 and was introduced by Senator Jesse Salomon (D) to allow adults ages 21 and older to lawfully use psilocybin in a supervised setting. In its first introduction, a Senate committee removed those provisions in February 2023. SB 5263 specified mainly on research and establish various bodies which would be tasked with reviewing scientific evidence and regulatory options regarding psilocybin, as well as providing recommendations to lawmakers. The amendment Macri pushed for brings the legislative measure closer to legal access.

“I thought we heard incredibly compelling testimony during the hearing about the potential benefits of psilocybin services,” she stated. “Particularly as they apply to people who have experienced trauma or depression that is difficult to treat.”

Before advancing the new legislation, the House Health Care and Wellness Committee passed two other amendments by Macri. The first amendment adjusted the framework of a proposed psilocybin advisory board to include two more individuals, which are a military veteran or veterans’ representative and someone who specializes in social work, mental health, or marriage and family therapy. The second amendment adds back in an option for some individuals to access psilocybin legally. It would also create a pilot program administered by the University of Washington (Seattle, Washington) and would offer psilocybin therapy services through a Food and Drug Administration (FDA) approved program which would be offered to veterans and first responders ages 21 and older and also experience post-traumatic stress disorder (PTSD), mood disorders, or substance use disorders.

https://www.marijuanamoment.net/washington-house-panel-amends-psilocybin-research-bill-to-add-patient-access-provisions-back-in/

A Washington State House Committee recently amended and then approved a psilocybin bill which will benefit patients.

Washington House Panel Adds in Psilocybin Research Bill Patient Access Provisions

Near the end of March 2023, Kentuckians calls were answered. Democratic Governor, Andy Beshear, met with lawmakers and advocates to sign Senate Bill 47. This historic legislation legalizes medical cannabis in the Commonwealth.

“In November, I signed an executive order to help Kentuckians with certain medical conditions, like our veterans suffering from PTSD, find safe and effective relief through medical cannabis,” Gov. Beshear said (1). “Now, I am finally able to sign this legislation into law and fully legalize medical cannabis — something the majority of Kentuckians support.”

This new bill creates a structure to regulate the medical cannabis program. It includes cultivators, processors, dispensaries, practitioners, products, and issuing identification cards to patients and caregivers. Another important section in the legislation is that it forms an authorization framework for practitioners to be able to recommend the use of medical cannabis and also establishes the cannabis business license application process and requirements.

“I am very happy to be here with friends to celebrate this special day. The signing of SB 47 comes after about five years of hard-fought legislative efforts,” bill sponsor Sen. Stephen West of Paris commented (1). “This bill is how the legislative process should work. Senate Bill 47 is probably one of the most vetted bills in the history of the General Assembly, going through numerous committees being worked and reworked numerous times. I am proud to be a part of that effort.”

“It is a true honor to be here today to celebrate this momentous legislation. For far too long, we have had to depend on the pharmaceutical companies pushing substances that have been a bane to rural Kentucky. I come from Eastern Kentucky, and I have seen firsthand the devastation that opioids have brought on my region,” said Sen. Phillip Wheeler of Pikeville (1). “I came here late to the issue, but I am glad I jumped on board and was able to play a small part in getting it over the finish line.”

“This is how it is supposed to be done. I am filled with emotion. There are thousands and thousands of Kentuckians who just want to be and want to feel better. This will help them with that,” Rep. Jason Nemes of Louisville stated (1). “This is such a good bill because there will be tens of thousands of Kentuckians who will never know our names, who have never walked these halls, but will be helped. I am happy to have played a small part in that.”

Senate Bill 47 assists Governor Beshear in his goal to fight the addiction of opioids and offer Kentucky citizens suffering from severe medical conditions such as, chronic pain, a safer option to treat their health conditions. The bill does not take effect until January 1, 2025, but, the Governor’s executive order will remain in effect, which allows individuals with certain health conditions, the option to receive medical cannabis from out of state until the new law is officially enacted.

Cannabis will be available to patients who receive a physician’s recommendation for one of the following conditions (2):

Chronic, severe, intractable, or debilitating pain

Multiple sclerosis, muscle spasms, or spasticity

Chronic nausea or cyclical vomiting syndrome

https://www.lebanondemocrat.com/portland/historic-legislation-legalizing-medical-cannabis-passes-in-kentucky/article_c227d9a0-60e2-50b2-945a-241127f30edc.html

https://www.safeaccessnow.org/ky_sb47_passes

Senate Bill 47, legalizing medical cannabis, was signed into law in March 2023 by Kentucky Governor Andy Beshear (D).

Kentucky Makes History Passing Legislation Legalizing Medical Cannabis

In late March 2023, Representatives Earl Blumenauer (D-OR) and Brian Mast (R-FL) introduced the Veterans Equal Access Act, which, if passed, authorizes health care providers at the Department of Veterans Affairs (VA) to recommend state-legal medical cannabis to veterans (1). Currently, physicians at the VA can be prohibited from discussing medical cannabis and veterans are not allowed to complete forms to participate in medical cannabis programs in any US state regardless of cannabis laws (1).

“I cannot tell you how many times I’ve visited VA clinics and had veterans tell me that medical marijuana saved their life,” said Blumenauer in a press release (1). “This legislation is a long overdue step that will benefit millions of our veterans who deserve equal access as their civilian counterparts to state-legal marijuana programs.”

“As I was recovering in Walter Reed, I was put on a laundry list of prescription medications from antidepressants to opiates,” added Mast, who lost both legs while serving in the Army in Afghanistan (1,2). “Thankfully, I was able to quit cold turkey, but there’s thousands who aren’t able. Our veteran population is facing multiple epidemics, including addiction and suicide, and we owe it to them to make sure they’ve got every tool possible in the arsenal to deal with the impacts of battle – that includes medical cannabis.”

The bill has received support from advocate groups including AMVETS, Veterans of Foreign Wars (VFW), National Organization for the Reform of Marijuana Laws (NORML), the Drug Policy Alliance, the National Cannabis Roundtable, and Veterans Cannabis Project (2).

“We’re pleased to see Representatives Mast and Blumenauer introduce the 

again in Congress and are encouraged by their continued dedication on behalf of our veterans,” said Veterans Cannabis Project Executive Director Stephen Jones (3). “Most veterans live in states where medical marijuana is now legal, but their doctors at the VA are hamstrung by outdated federal policy when it comes to even simple things like making program recommendations or filling out forms. This bipartisan bill is a step in the right direction toward closing that care gap. The healing, recovery, and reintegration process is already hard enough for our service members, and we owe it to them to cut through the red tape when it comes to getting the help they need.”

On March 30, 2023, Representatives Blumenauer and Mast held a 

 with reporters to speak in depth about the bill. The bill now awaits consideration by the House Committee on Veterans Affairs (1).

Interested in deeper dive into the progress made for veterans and medical cannabis by Blumenauer and Mast? Read more coverage from 

https://www.cannapatientcare.com/view/bipartisan-support-steps-in-to-help-veterans-access-to-medical-cannabis

https://blumenauer.house.gov/media-center/press-releases/blumenauer-mast-introduce-veterans-equal-access-act

https://hightimes.com/news/house-lawmakers-reintroduce-bipartisan-veterans-equal-access-act/

https://www.vetscp.org/news/2023/3/31/statement-veterans-cannabis-project-applauds-representatives-mast-amp-blumenauer-for-introducing-access-bill

Bipartisan legislation was recently reintroduced to remove barriers preventing veterans accessing medical cannabis as recommended by health care providers at the VA.

Veterans Equal Access Act Introduced to Allow Veterans Affairs Doctors to Recommend Medical Cannabis

Colorado-based Vantage Hemp Co. announced today that it submitted a Drug Master File (DMF) for its cannabidiol (CBD) isolate to the Food and Drug Administration (FDA), having submitted one for its CBD distillate in 2022 (1).

“Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products,” stated the FDA website (2).

“Drug Master Files move the CBD industry forward with professionalism and legitimacy,” said Deepank Utkhede, Vantage’s Chief Operating Officer (1). “This is a significant milestone for our company. We believe that a commitment to consistency, quality, and cGMP compliance will help pave the way for greater regulatory clarity in the industry.”

With large-scale extraction facilities, Vantage Hemp Co. reportedly produces current good manufacturing practice (cGMP)-compliant CBD extracts including full-spectrum oil, distillate, and isolate.

https://www.vantagehemp.com/2023/04/03/vantage-hemp-co-submits-drug-master-file-for-cbd-isolate-to-the-u-s-food-drug-administration/

https://www.fda.gov/drugs/forms-submission-requirements/drug-master-files-dmfs

A pharmaceutical company, Vantage Hemp Co., announced it recently submitted two Drug Master Files (DMFs) to the Food and Drug Administration.

Two CBD Drug Master Files Submitted to the Food and Drug Administration

Iranian Journal of Pharmaceutical Research

, the phase I randomized, double-blind, placebo-controlled study aimed to evaluate the safety profile and efficacy of a cannabis-based sublingual spray, CBDEX10 (containing 100 µg cannabidiol and 10 µg Δ9-tetrahydrocannabinol per puff; CBD/Δ9-THC 10:1) (1).

The study tracked 50 diabetic patients over an eight-week treatment period to assess the efficacy of the twice daily administered supplementary therapy in controlling the glycemic state and lipid profile of the patients (1). It noted prior research on cannabis use and insulin levels and body mass index in the rationale behind using a combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) in conjunction with the main anti-diabetic medication (1).

“In the present study, we demonstrated that sublingual administration of the CBDEX1 sublingual spray, two puffs twice daily through an eight-week treatment period, could effectively improve the patient's lipid profile and glucose tolerance. Moreover, the mentioned regimen could also improve insulin sensitivity,” the study concluded, noting a statistically significant decline in total cholesterol in the supplement group by the end of the study (1). “Overall, CBDEX1 sublingual spray could be a new therapeutic agent for lipid and glycemic control in diabetic patients.”

There were no statistically significant differences regarding demographics or adverse effects between the supplement and placebo groups (1).

Afshar, S.; Khalili, S.; Amin, G.; Abbasinazari, M. A Phase I Randomized, Double-Blind, Placebo-Controlled Study on Efficacy and Safety Profile of a Sublingually Administered Cannabidiol /Delta 9-Tetrahydrocannabidiol (10: 1) Regimen in Diabetes Type 2 Patients. 

One recently published study suggests that a cannabis sublingual spray may be beneficial in the treatment of type 2 diabetes.

The Effects of a Sublingual Cannabis Spray on Patients with Type 2 Diabetes

Listen as "America's Combat Nurse" Cherissa Jackson, CEO/Founder of WE DECODE LLC, shares how she envisions the medical track for the 2023 conference.

Join the conversation around medical cannabis! Register here to attend Cannabis Science Conference Spring, April 19-21 in Portland, Oregon: 

https://www.cannabisscienceconference.com/

What is Cherissa Jackson, RN most excited about as the medical track program chair for Cannabis Science Conference?

Insights into the Medical Cannabis Track with Cannabis Science Conference Program Chair Cherissa Jackson

The study was published on March 14, 2023 in the United Kingdom (UK) journal 

, which is the UK’s leading independent scientific body on drugs (1). The case study follows a 61-year-old woman who was prescribed a medication for chronic pain and though her pain was well-controlled by the medication, she reported side effects such as hearing loss, sleepiness, tinnitus, confusion, and worsening anxiety (2).

“Prescribed cannabinoids are legal in the UK and are increasingly being used for a variety of conditions, with one of the most frequent conditions being chronic pain,” read the abstract of the study (2). “Here we present a case study of a 61-year-old woman with idiopathic small fibre neuropathy, who was prescribed the gabapentinoid pregabalin, in combination at different times with various other agents…over a 17-year period for the associated neuropathic pain.”

After attempts to decrease the dose of pregabalin had failed, in 2021 she enrolled in Project Twenty21, the UK's first medical cannabis registry (2). “She was prescribed full plant extract delta-9-tetrahydrocannabinol 10 mg: cannabidiol 15 mg/mL of oil, prescribed at a dose range of 0.1–0.5 mL twice daily,” the abstract said. “As a result, the patient managed to reduce her pregabalin down to 37.5 mg total daily dose.”

“Launched in August 2020, Project Twenty 21 (T21) is a multi-centre, observational patient registry for patients seeking treatment with prescribed cannabinoids,” the study explained (2). “The over-arching goal of T21 is to collect prospective data from substantial numbers of people who receive CBMPs for a variety of conditions, in order to contribute to both the scientific literature and regulatory aspects on the safety and effectiveness of these products in real-world settings.” In this way, T21 also allows medical cannabis patients to obtain CBPMs at a discounted price (1).

“The patient now feels she has ‘been given a second chance at life’ and her husband describes her as ‘a new woman’,” the abstract concluded (2). “This patient feels that she is in a position to finally stop treatment with pregabalin, as a result of medical cannabis controlling her pain. Highlighting the potential benefits of cannabis-based medicinal products to treat chronic pain, our case study indicates the value of including real-world evidence when assessing the benefits and safety of cannabis-based medicinal products.”

The study outlined the current recommendation from UK’s National Institute for Health and Care Excellent (NICE) for neuropathic pain, and noted that NICE does not recommend the prescription of CBMPs for chronic pain due to a variety of complex reasons (2). “Medical cannabis offers clinicians another treatment option and should be considered especially once all recommended treatments have failed or are only achieving partial pain management,” the study continued. “As with other drugs, CBMPs need to be embedded in a multimodal treatment plan, with appropriate safeguarding support, and ongoing pharmacovigilance such as provided by T21.”

As a final note, the study included the patient’s testimonial. “I have had peripheral neuropathy for over 17 years and I have tried all sorts of medications and treatments, (traditional and alternative), too many to mention but include ketamine infusions and I even twice trialed a spinal cord stimulator. Nothing has come anywhere close to the pain relief I gain from the prescription cannabis that I have been taking whilst on the Twenty21 Trial,” it read in part (2). “I am so very grateful that Peter Sunderland, the pharmacist at my GP's surgery, persuaded me to go on the trial. My family and friends have all remarked on how well and happy I am now.”

https://www.analyticalcannabis.com/news/cannabis-helps-woman-to-reduce-medication-use-for-nerve-pain-case-study-reports-314683

Sunderland, P.; Nutt, D. J.; Schlag, A. K. Medication Sparing after Medical Cannabis Initiation: A Case Study of a Chronic Pain Patient in Project TWENTY21. 

A recently published case study documents one chronic pain patient’s reduction of prescribed pain medication after being referred to a medical cannabis registry. Prescribed cannabis-based medicinal products (CBMPs) have been legal in the UK since 2018.

One Case Study Shows How a Woman in the UK Reduced her Prescription Pain Medication With Cannabis

This latest bill would add individuals suffering from chronic pain to the list of qualifying medical cannabis patients under the state’s current existing medical cannabis program (1).

Texas’s new legislation specifically adds chronic pain patients who were often prescribed opioids to treat their condition, to the list of patients with medical conditions who are able to obtain medical cannabis through the Texas Compassionate Use Program (2). This program allows doctors to prescribe low-tetrahydrocannabinol (THC) cannabis products to qualifying patients, such as those suffering from cancer, multiple sclerosis (MS), epilepsy, and more.

’s Anthony Martinelli (3), reported that the Calendar Committee will now be scheduling HB 1805 for consideration by the full Texas House of Representatives. A companion senate bill has also been assigned to the Senate Health and Human Services Committee. The bill was authored by Rep. Stephanie Klick (R) who is also the chair of the House Public Health Committee.

https://www.chron.com/news/houston-texas/article/texas-medical-marijuana-17851591.php

https://www.texas.gov/health-services/texas-medical-marijuana/

https://themarijuanaherald.com/2023/03/texas-chronic-pain-medical-marijuana-thc-cap/

In March 2023, Texas lawmakers approved of House Bill 1085.

Texas Expands Medical Cannabis Access

The cannabis industry is growing every day with more support. According to Dr. Peter Grinspoon's new book (1), one in seven Americans use a type of cannabidiol (CBD) product. Additionally, 94% of Americans support the legalization of medical cannabis and 69% wish to see total legalization. In this book, Dr. Grinspoon will cover how spiked research was done in the past to devalue the medicinal properties of cannabis and aimed to find harm. The cannabis used for testing now with the government is unfit to yield quality data. One thing Dr. Grinspoon encourages and hopes to see change is for medical professionals, such as other doctors, to educate themselves on cannabis. 

“Throughout the second half of the nineteenth century and right up until 1937, when cannabis became effectively prohibited in the United States by the Marihuana Tax Act, doctors routinely prescribed cannabis tinctures and considered it to be an effective, mainstream medicine,” Grinspoon mentions in his book. He hopes that his new book will help inform but also guide readers on their cannabis journeys.

https://mgmagazine.com/press-releases/the-science-about-mj-explained-in-new-book-by-esteemed-cannabis-expert/

Physician and cannabis expert, Dr. Peter Grinspoon, has released his new book titled,”Seeing through the Smoke.” In this informative piece of literature, Dr. Grinspoon discusses separating fact from fiction, cannabis research, and a guide on how to use cannabis safely.

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