VIREO RELEASES PROTOCOL AIMED AT REPLACING OPIOIDS WITH MEDICAL CANNABIS

For Immediate Release

April 6, 2016

Media Contact: Jill Montag – 518-852-8188

Vireo Releases Protocol Aimed at Replacing Opioids with Medical Cannabis    

Groundbreaking Observational Study to be Launched this Summer 

New York, NY – Vireo Health, a physician-led medical cannabis company, announced today the release of a protocol designed to reduce the number of deaths each year from the use of highly addictive opioid pain medications such as oxycodone, morphine, hydromorphone and the illicit, related street drug heroin.

This first-of-its-kind draft protocol is being called FREDOM (Flexible Reduction and Expedited Discontinuation of Opioid Medications) and has been developed to offer a potential path for physicians to help patients struggling with chronic or intractable pain replace opioids with medical cannabis. The protocol has been published in draft form as a ‘working paper’ in order to elicit feedback from the largest possible number of physicians and researchers.

In 2014, nearly two million Americans abused or were dependent on prescription pain killers, and more than 14,000 people died as a result of their use, according to the federal Centers for Disease Control and Prevention (CDC). The number of deaths has quadrupled since 1999. Each day, almost 1,000 Americans are treated in emergency rooms for using these drugs improperly.

“As an emergency medicine physician, I saw firsthand that opioids are overused, frequently abused and too often result in fatal overdoses,” said Kyle Kingsley, M.D., Vireo Health’s Chief Executive Officer. “The noble war against opioids can only be won through collaboration, which is why we have invited researchers and physicians from around the world to offer their expert feedback on the FREDOM protocol. We view this protocol and the data that will follow as a first step in combating this public health crisis.”

Similar to software developers releasing their original source code into the public realm for free in the hopes that others will test and improve upon the code as they see fit, Vireo is taking an ‘open source’ approach to its draft protocol. Over time, Vireo hopes that feedback will contribute to an improved understanding about the extent to which medical cannabis can serve as a viable alternative to opioids.

Vireo is starting observational data collection around the FREDOM protocol this summer. This observational study seeks to enroll a minimum of 100 patients. As of April 2016, Vireo Health’s two subsidiaries – Vireo Health of New York and Minnesota Medical Solutions – had access to a population of more than 3,000 patients certified by physicians to use medical cannabis under their respective State laws.

Beginning on August 1, 2016, patients in Minnesota with intractable pain — pain that can’t be relieved or cured with other methods — can be authorized to purchase cannabis-based medicine. Many of these patients use opioids on a regular basis and will therefore qualify to participate in the planned observational study. Since New York law does not currently include intractable pain as a qualifying medical condition to become eligible for the State’s medical marijuana program, a much smaller number of patients would likely qualify for the study.

“We will be working closely with researchers, patients’ primary care physicians and physicians who specialize in pain management to learn more about a medically sound approach for potentially reducing the use of opioids,” said Laura Bultman, M.D., Vireo’s Chief Medical Officer. “While existing research is encouraging, the draft protocol represents an important step towards bringing more rigor and consistency to the medical cannabis field and finding safer possible options for patients.”

There are compelling reasons that opioids such as hydrocodone, oxycodone, oxymorphone, and methadone could be at least partially replaced by cannabis-based medicines. A February 2016 article in the Clinical Journal of Pain (The Effect of Medicinal Cannabis on Pain and Quality of Life Outcomes in Chronic Pain), showed a 44% reduction in opioid pain medication usage in chronic pain patients utilizing medical cannabis. Another study (Medical Cannabis Laws and Opioid Analgesic Overdose Mortality in the United States, 1999-2010) found that states with medical cannabis laws had a 24.8% lower mean annual opioid overdose mortality rate compared with states without medical cannabis laws.  Additional studies since then have shown a reduction in opiate use in chronic pain patients using cannabis for pain treatment.

“Reducing opioid misuse and abuse is one of my top priorities as a physician, said Stephen Dahmer, M.D., Chief Medical Officer of Vireo Health of New York. “Patients deserve sound options when faced with pain and suffering. This application of medical cannabis has that potential and could have major public health implications both in the United States and beyond.”

“Medical cannabis has fewer side effects than opioids and has already proven effective for many of my patients. In fact, some have already been able to reduce their opioid dosage,” said Grace I. Forde, MD, a New York-based neurologist who specializes in pain medicine and is not affiliated with Vireo Health. “We have a huge public health problem in this country with opioids and this protocol is a step in the right direction.”

“As a physician who regularly prescribes opioids for debilitating pain, I have witnessed many patients struggle with the adverse side effects, and for some, limited analgesic effect especially for chronic non-malignant pain,” said Craig D. Blinderman, M.D., M.A., a New York City-based physician who specializes in palliative care, and is not affiliated with Vireo Health. “It is my sincere hope that FREDOM protocol data will help us develop a better understanding of how medical cannabis could be used, by certain patients, as a safe and effective alternative to opioids.”

“Early evidence suggests a role for medical cannabis to minimize opioid use, and possibly provide an alternative to opioids, in the treatment of pain,” said Charles Reznikoff, M.D., a Minneapolis-based internal medicine physician who specializes in addiction, and is not affiliated with Vireo Health. “If proven true, this would improve lives and possibly prevent accidental opioid overdose. This is an important area of research.”

“This protocol could become an invaluable tool in our fight against opioid misuse and abuse,” said Jonathann Kuo, MD, Executive Director of Hudson Spine and Pain Medicine, an entity not affiliated with Vireo Health. “Identifying new and effective methods to help pain patients reduce their reliance on opioid-based medications is a top public health priority.”

“I find the protocol to be user-friendly which in many ways is a prerequisite for success,” said Kristen E. Sahler, MD., a Westchester-based neurologist who specializes in headache medicine, and is not affiliated with Vireo Health. “We need to be open to new ideas and approaches to help combat the opioid epidemic.”

“This is a very worthy study and I am hopeful it will prove successful,” said Sunil Kumar Aggarwal, M.D., Ph.D., a Seattle-based physician who specializes in palliative medicine, and is not affiliated with Vireo Health. “It would be groundbreaking if a trusted and well-tested protocol were available to physicians to help guide patients on how to reduce opioid use with medical cannabis.”

The FREDOM protocol is available for download at http://vireohealth.com/research. Physicians and researchers are invited to provide feedback and learn more about the planned observational data collection through the Company’s website or by emailing providers@vireohealth.com.

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Important Note 

Vireo Health has published the FREDOM protocol in draft form, and modifications are highly likely over time.  Utilization of this protocol or variants thereof in patient treatment plans are at the sole discretion of patients’ primary treating physician. The draft FREDOM protocol along with the information contained in this press release have not been evaluated by the Food and Drug Administration or any other regulatory body. Vireo Health is making absolutely no statements as to the efficacy of cannabis based medicines in the treatment of pain or other medical conditions.

About Vireo Health 

Vireo Health, LLC is a physician-led company dedicated to alleviating pain and suffering by providing patients with high-quality cannabis-based products and compassionate patient care. Vireo is the parent company of two wholly-owned subsidiaries licensed to operate in New York and Minnesota – Vireo Health of New York and Minnesota Medical Solutions. For more information, visit www.vireohealth.com.

Observational Study

Vireo’s planned observational study utilizing the FREDOM protocol will enroll a minimum of 100 patients. To become eligible to participate, patients must meet all of the following criteria:

  • 21 years of age or above
  • Resident of New York or Minnesota
  • Actively using opioids for more than 90 days (i.e. OxyContin®, Percocet®, and Vicodin®)
  • Certified by their physician to use medical marijuana along with Vireo’s FREDOM protocol
  • Provide consent to participate in data collection monthly for a period of 90 days up to one year

Pregnant women, nursing mothers, and individuals with a personal or family history of psychosis are ineligible to participate.

Research & Federal Policies

Last week, President Obama announced additional actions to address the prescription opioid abuse and heroin epidemic (White House Fact Sheet).

In a February 8, 2016 letter, US Senator Elizabeth Warren asked CDC Director Dr. Tom Friedan to explore “the impact of the legalization of medical and recreational marijuana on opioid overdose deaths.”

A September 2015 article in the Drug and Alcohol Review (Substituting cannabis for prescription drugs, alcohol and other substances among medical cannabis patients: The impact of contextual factors) found that 80.3% of those surveyed reported substituting cannabis for prescription drugs.

A July 2015 paper published by the National Bureau of Economic Research (Do Medical Marijuana Laws Reduce Addictions and Deaths Related to Pain Killers?) found that “providing broader access to medical marijuana may have the potential benefit of reducing abuse of highly addictive painkillers.”

An October 2014 article in the Journal of the American Medical Association (Medical Cannabis Laws and Opioid Analgesic Overdose Mortality in the United States, 1999-2010) found that medical cannabis laws are associated with significantly lower state-level opioid overdose mortality rates. Specifically, states with medical cannabis laws had a 24.8% lower mean annual opioid overdose mortality rate compared with states without medical cannabis laws.

There is ample reason to believe that opioids could be replaced, in part, by cannabis. A February 2016 paper published in the Clinical Journal of Pain: The Effect of Medicinal Cannabis on Pain and Quality of Life Outcomes in Chronic Pain, showed a 44% reduction in opioid use in chronic pain patients taking medical cannabis.

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