- Cannabinoid drugmaker Tetra Bio-Pharma announced a co-development agreement with Storz & Bickel to market Tetra’s PPP001 drug for patients with fibromyalgia in Canada.
- Storz & Bickel’s inhalation device, dubbed the Mighty Medic, will be used with PPP001 for fibromyalgia and other indications, and potentially with another Tetra cannabinoid formulation now in development.
- The Mighty Medic is a portable herbal vaporizer approved for cannabis use by Health Canada, and will be eligible for insurance reimbursement under Canada’s provincial insurance programs.
The new co-development agreement will enable Tetra to expand the use of PPP001, now being studied in a Phase 3 Canadian clinical trial for cancer pain, into the fibromyalgia market. Fibromyalgia affects four million adults in the U.S., and just three medications are U.S. Food and Drug Administration-approved specifically for its treatment. However, a number of drugs, including anticonvulsants, antidepressants, corticosteroids, NSAIDs and the opioid antagonist naltrexone, are now used off label to treat the symptoms of fibromyalgia, including pain, sleeplessness, and depression.
Yet controversy has long dogged the use of pharmaceuticals for fibromyalgia. While most medications for fibromyalgia have some benefit for patients, none provide relief from all the symptoms of the disease. Patients often switch from one drug to another over time, since only 35% to 40% of patients respond to medication therapy.
A 2016 study of 76 fibromyalgia patients on medication therapy, for instance, found that 25% got better over two years, while 35% experience worsening health. And a Cochrane review study, published earlier this year, found insufficient evidence to show whether or not multiple drugs were more effective than single medications in managing fibromyalgia symptoms.
In Canada, the most commonly used prescribed medications for fibromyalgia are Lyrica (pregabalin), Cymbalta (duloxetine), Xyrem (sodium oxybate) and Vimpat (lacosamide), according to Tetra. Yet treating fibromyalgia patients can be daunting, and most experts recommend both medications as well as other therapies, such as cognitive behavioral therapy, exercise and even massage.
"As practitioners we have the daunting task of moving our patients from unrelenting neuropathic pain to improved function and better quality of life," said Gordon Ko, medical director of fibromyalgia clinics at the Canadian Centre for Integrative Medicine. "The clinical use of cannabis in the management of fibromyalgia suggest these patients obtain significant relief," he added in a statement.
Yet there has been reluctance in both the U.S. and Canada to embrace the use of marijuana-based drugs. The FDA has approved only one cannabis-based drug, Epidiolex, for seizures related to Dravet syndrome and Lennox-Gastaut syndrome, two rare forms of epilepsy. In Canada, the use of cannabis has been legal for 17 years, but health insurers there only recently began to cover it for treatment of a handful of medical conditions.
Both insurers and clinicians are concerned about the high cost of cannabis treatment, as well as its efficacy. In fact, the Canadian Medical Association has warned its members to proceed with caution in using cannabis as a medical treatment, citing lack of scientific evidence supporting its use. CMA experts as well as medical center executives have also voiced concerns about whether marijuana can effectively reduce the use of other medications, when both are used in a treatment regimen.