This is a recurring column on clinical research in the early stages of development, which is referred to as phase 1. These are treatments being used for the first time in a small number of human patients to determine safety, dosing and general pharmacological activity.
Opioid-free painkillers have long been a goal of the pharmaceutical industry, and with the COVID-19 pandemic keeping patients at home, some companies are exploring ways digital health could be applied to mitigate pain from home.
One of the first challenges of evaluating pain in clinical trials is simply how differently patients experience it, Biofourmis Inc. CEO Kuldeep Singh Rajput said in an interview. The company has formed a partnership with Tokyo-based Chugai Pharmaceutical Co. Ltd. to develop Biofourmis' digital pain management platform in patients with endometriosis. The companies have enrolled 120 patients in a global study to test a wearable biosensor and companion patient-facing app.
Biofourmis CEO Kuldeep Singh Rajput
Endometriosis is a condition in which uterine tissue grows outside of the uterus, causing patients pain and menstrual irregularities.
The Boston-based digital therapeutics company became interested in pain management following research into patient outcomes after orthopedic surgery. Rajput said they found that not only were patients becoming addicted to prescribed opioids following surgery, but clinicians were having trouble deciding when to initiate or stop opioid treatments.
Using a combination of biosensors and artificial intelligence, the Biovitals platform aims to provide an objective measurement for pain. The platform, which rates the level of pain on a scale of zero to 10, will help patients receive better treatment for their pain by allowing clinicians to optimize dosages and personalize therapy, according to Rajput.
"Just using a single parameter to accurately quantify pain level really doesn't work," Rajput said.
The platform measures more than 20 physiological biomarkers that may indicate pain, rather than just one, such as heart rate variability. The sensor can eventually detect changes in an individual's biomarkers using machine learning technology.
"Many pharma companies are envisioning that they will move into leveraging digital technology combined with their drug portfolio to augment the value of the drug and provide more personalized care to the patient," Rajput said. For instance, Abbott Laboratories recently received U.S. approval for the Patient Controller app, which will allow patients with chronic neurological pain to monitor their condition.
That is exactly the goal of the Chugai-Biofourmis partnership, with plans for the Biovitals platform to be used as a combination therapy with Chugai's pharmaceuticals. The study is expected to be completed in the first quarter of 2021. Chugai is a subsidiary of Swiss pharmaceutical giant Roche Holding AG.
As the COVID-19 pandemic has put a strain on many health organizations, companies like private Los Angeles-based AppliedVR Inc. have seen providers, payors and regulators recognize the need for digital health tools to aid pain management.
AppliedVR CEO and Co-founder Matthew Stoudt
AppliedVR views pain as more than just a physiological sensation. According to CEO Matthew Stoudt, pain also has a biological, social and psychological paradigm. Patients with chronic pain often have other conditions such as sleeplessness, anxiety and depression that can exacerbate the condition.
"When you're trying to ... help a patient address their chronic pain, you need to take that holistic approach," Stoudt said.
For AppliedVR, this means creating virtual reality experiences for patients. The company's eight-week-long chronic pain program provides different virtual reality sessions and interactive experiences for users. In a session, patients might virtually go inside their own body to learn how pain is actually impacting them, or they might watch their breath come in and out.
"Think of it as an opioid-sparing technology," Stoudt said.
In a recently published study of 74 people with chronic lower back pain or fibromyalgia pain, AppliedVR's virtual reality therapy was found to reduce pain intensity by an average of 30% over a 21-day period. Pain-related mood interference reduced 50% and pain-related activity interference reduced 37% in patients using the at-home therapy.
The company is working on a separate, larger study sponsored by the National Institute on Drug Abuse that is set to begin in September to examine the virtual reality technology on patients with lower back pain.
Stoudt hopes that their technology will ultimately be proven to be a safe and effective mode of treatment for people who are coming off of opioids and people who never use them in the first place.
A 2012 Johns Hopkins University study published in The Journal of Pain said chronic pain costs the U.S. $635 billion a year. AppliedVR's therapy, if proven effective in the ongoing studies, could provide a cost-effective treatment, according to Stoudt.
"If you can even help stave off [one] patient from making a run to the emergency department, or delay beyond that surgery or even enable them to preclude surgery completely, that's huge cost savings for the system," Stoudt said.