Cannabis as an Alternative to Opioids: Exclusive Interview with Resolve Digital Health
January 29th, 2018
Exclusive, News, Top News
By now, most everyone is aware of the opioid epidemic in the United States. Overdose deaths are now the leading cause of death for Americans under 50. According to GBI Research, the U.S. market is slated to grow from about $11 billion in 2014 to $17.7 billion in 2021. Additionally, the cost of treating opioid addiction and overdose is estimated to be over $78 billion.
Preliminary research has shown that cannabis may be an alternative to opioids for pain management but rigorous clinical trials have been lacking to this point for a variety of reasons. Resolve Digital Health plans to change that with a series of trials aimed at providing a viable alternative treatment to opioids. Not only does this present and enormous financial opportunity for Resolve, the company also would provide an extremely valuable social service.
CFN Media recently sat down with the company’s Director of Clinical Research, Joe Reiz, to discuss these momentous trials and what the company hopes to achieve.
1) You joined Resolve Digital Health in November 2017 to spearhead its new clinical research program. Can you talk to us a bit about your deep background in more traditional pharmaceutical research, and about what attracted you to the opportunity with Resolve Digital?
Sure. I have over 28 years of experience in clinical research in the pharmaceutical industry most of which has been in the area of central nervous system disorders such as ADHD, pain management, epilepsy, schizophrenia, depression, stroke and brain injury. Over the last 20 years, I designed and managed clinical trial programs that resulted in new product approvals. My work has been published in scientific journals and has been presented at scientific conferences.
What attracted me to Resolve Digital Health is the company’s commitment to improving outcomes for patients, particularly in the area of pain management. For 18 years, I worked for Purdue Pharma Canada, the manufacturers of controlled-release opioids so I understand the importance of the how effective pain management can positively change the lives of people suffering with pain. However, as we know, there can be devastating consequences associated with the use of opioids so physicians and patients are searching for safer alternatives. Medical cannabis is one of those options. However, there is also a need for well-conducted research with medical cannabis and Resolve Digital Health’s commitment to conducting such research was the main reason for my joining the company.
2) The initial trials are focused on pain management, and more specifically on the use of prescribed opioid drugs versus Resolve’s smart inhalers that employ medical cannabis to treat chronic pain. What do you hope to accomplish with these studies?
Medical cannabis has the potential of replacing some of the opioid use for chronic pain, delaying the use of opioids until the pain becomes severe, or reducing the amount of opioids a patient requires. Although some research has been conducted in those three areas, much more needs to be done in order to move cannabis into the mainstream for pain management. Resolve’s Smart Inhaler™ uses a pre-filled pod system that take the guesswork out of dosing and it also collects data that can be used by both the patient and the physician to optimize treatment outcomes with medical cannabis. Resolve Digital Health will be conducting studies to explore how the medical cannabis administered by the Breeze Smart Inhaler™ can reduce, delay or replace the use of opioids in patients with chronic pain. Our intent is to provide the medical community with the information they need to make informed decisions as it relates to prescribing cannabis instead of, or in combination with opioids.
3) Will Resolve’s offerings be focused exclusively on Pain Management or will you be exploring cannabis as a treatment to other conditions as well?
Yes, we will be exploring other therapeutic areas such as sleep, anxiety, depression, arthritis, headache or migraine, PTSD, opioid dependence and tumour reduction. We will be working in close partnership with the medical community to assist in the focus and development of these programs.
In addition, we will be partnering with physicians to develop comprehensive wellness programs, which will include medical cannabis therapy, for a variety of medical conditions.
4) A doctor’s prescription is needed for medical cannabis – so in essence, they are the gate keeper to this medicine. How do you think these clinical studies will affect the medical community’s view on prescribing cannabis?
Physicians rely on evidence-based medicine and the lack of well-designed studies with medical cannabis presents a challenge for the medical community. In addition, physicians are used to prescribing therapies with established doses in convenient dosage formats. The goal of our studies will be to both provide physicians with information on the efficacy of medical cannabis and to validate the pod-based dosage format we have developed for our Smart Inhaler™. In that way, it will provide physicians with the information and confidence they need to prescribe medical cannabis.
5) Let’s talk about Resolve’s Smart Inhaler™ for a second, as the device and its data platform play a key role in the studies. What does the device do and how can it improve your research over using more traditional cannabis delivery methods?
Our Smart Inhaler™ improves treatment outcomes in several ways. The first is that is uses pre-filled pods. The patient does not have to figure out which strain is best for their particular condition – through our research programs, we will do all that work for them. There’s also no need to grind or weigh the cannabis or clean the inhaler. They simply insert a pod into the device. Once the pod is depleted of medical cannabis, the patient just pops the pod out and it is ready to use again.
The second has to do with dosing. Patients won’t have to guess as to the right dosing amount. Through machine learning, our device will learn about the patient and suggest dosing times and amounts, effectively personalizing their treatment in ways that simply isn’t possible in the traditional cannabis space – or the pharmaceutical space for that matter.
Lastly, is the collection and sharing of data. Patients will be able to record a variety of data with the software including information about frequency of use, dosing, strain type, level of pain, concomitant medications, etc. This information can be used by the patient or shared with their physician to optimize their treatment outcome. In a research setting, this eliminates the need of patients to remember what medications they took or the level of pain they experienced when they see the doctor for follow-up visits. This software will be available on the commercial version of the device as well as the research version.
6) It seems like the data you’re collecting through the device carries enormous value in helping improve the patient experience and building a collaborative health care model with the doctors. Could you speak to how this data will be used?
Typically, when physicians prescribe a medication to a patient, the patient returns to the clinic after a period of time, often weeks or sometimes months, to review how well the medication worked and how well it was tolerated. The patient must rely on their memory about their experience with the treatment and the physician receives little information to make a decision whether to modify the treatment. This is even a more difficult task with medical cannabis due to the large number of strains and dosage forms available. By systematically collecting data from the patient as it happens, the physician will have much more data – and far more accurate data from which to base their decisions. By empowering the patient with their own treatment and sharing information with their caregivers, our Smart Inhaler™ allows the physician to partner with the patient in determining the best possible treatment.
7) What is the schedule for launching and completing these research programs? And when can we expect to see the Inhaler in the market?
We are anticipating the launch of our first study to occur in Q2 of this year. This will be in line with our Smart Inhalers™ being available in market as well.
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