A new clinical study led by Israeli researchers and publicized this week has shown that controlled, inhaled doses of THC – the principal psychoactive constituent of cannabis – can effectively relieve pain in patients who are chronic sufferers.
The double‐blind, placebo‐controlled study was conducted between March 2016 and July 2017 with 25 patients of a mean age of 48 at the Pain Research Unit of the Rambam Health Care Campus in Haifa in partnership with Israeli medical device firm Syqe Medical, the developer of the world’s first selective-dose, pharmaceutical-grade medicinal plants inhalers.
The devices were used in the cannabis study, published in May in the peer-reviewed medical journal the European Journal of Pain. Results showed that inhalation of 0.5 mg (500 micrograms) or 1mg (1 milligram) of THC contributed to “a significant reduction in pain intensity compared with baseline and remained stable for 150 min.”
“All patients in the clinical trial suffered from chronic pain with a baseline pain intensity of six or above on a 10‐cm visual analog scale (VAS),” Syqe’s clinical team tells NoCamels via email. “Most patients were suffering from chronic focal or distal symmetric (diabetic) neuropathic pain [caused by damage or disease affecting the somatosensory nervous system], and six from complex regional pain syndrome (CRPS) [believed to be caused by damage to, or malfunction of, the peripheral and central nervous systems].”
The trial examined blood THC levels, pain relief, cognitive functions and psychoactivity, and according to the researchers, any adverse effects of the THC “were mostly mild and resolved spontaneously.” There was also “no evidence of consistent impairments in cognitive performance.”
The authors of the study included Professor Elon Eisenberg, who led the trial and sits on Syqe’s scientific advisory board, and Dr. Shlomo Almog of the Department of Physiology and Pharmacology at Tel Aviv University’s Sackler School of Medicine and the Institute of Pharmacology and Toxicology at the Sheba Medical Center who is also a consultant for Syqe.
Syqe Medical was founded in 2011 by Perry Davidson and developed two variations of its novel inhaler – one for individuals and one for medical institutions that consists of a caregiver interface for professional healthcare use. The device provides precise dosages to patients that can also be remotely administered by doctors.
The inhalers are approved by the Israeli Health Ministry and marketed by Israeli pharmaceutical multinational Teva. The company’s CE approval in Europe is pending.
Syqe’s current patients, the team tells NoCamels, include patients suffering from chronic pain (including neuropathic pain, chronic muscle pain, fibromyalgia, cancer pain, phantom pain, spasticity and CRPS), as well as patients being treated for other cannabis indications approved by the Israeli Health Ministry (for example, post-traumatic stress disorder (PTSD), Crohn’s disease).
‘First scientific confirmation’
The researchers wrote that although there is evidence that suggests cannabis‐based medicines are effective in treating chronic pain in adults, this study has “demonstrated that a metered‐dose cannabis inhaler delivered precise and low THC doses, produced a dose‐dependent and safe analgesic effect in patients with neuropathic pain/ complex‐regional pain syndrome (CRPS).”
“We can conclude from the study results that low doses of cannabis may provide desirable effects while avoiding cognitive debilitations, significantly contributing to daily functioning, quality of life, and safety of the patient,” said Professor Eisenberg, also the dean of the Faculty of Medicine at the Technion-Israel Institute of Technology.
“The doses given in this study, being so low, mandate very high precision in the treatment modality. This precision is unique to the Syqe drug delivery technology, enabling cannabis dosing at pharmaceutical standards,” he added.
The Syqe device “delivers significantly low and precise doses of THC, thus allowing the administration of inhaled cannabis‐based medicines according to high pharmaceutical standards. These low doses of THC can produce safe and effective analgesia in patients with chronic pain,” according to the researchers.
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It allows patients to reach the optimum balance between symptom relief and controlled side effects, enabling patients to regain their quality of life, noted the authors, adding that the inhaler “enables the individualization of medical cannabis regimens” that can be evaluated on several levels.
Syqe said the trial was the “first scientific confirmation that microdosing – the process of using extremely low doses of active drug compounds to treat various conditions – actually works with cannabis.”
“This study is the first to show that human sensitivity to THC is significantly greater than previously assumed, indicating that if we can treat patients with much higher precision, lower quantities of [the] drug will be needed, resulting in fewer side effects and an overall more effective treatment,” said Davidson, Syqe’s CEO, in a company statement.
Davidson noted that the delivery platform “is also applicable to opioids and other compounds that, while potentially effective, are notoriously associated with dangerous side effects.”
Syqe is meant to replace other pain relievers, at least partially, notes the clinical team.
“Typically, patients with chronic require more than a single pain reliever for optimal pain relief. We have observed that the majority of our current patients in Israel reduced their pre-Syqe pain medication (including opioids) and in some cases, replaced them, under the supervision of their treating physicians,” they tell NoCamels.
Syqe is now exploring options for a variety of therapeutic areas including central nervous system disorders, sleep, anxiety, and cancer, the company indicated.
“The introduction of a tool to prescribe medications at such low doses with such high resolution may allow us to achieve treatment outcomes that previously were not possible,” Davidson said.
Syqe is now preparing to file for FDA approval and says it expects the study to “draw the FDA’s attention to the possibility of delivery of cannabis for inhalation with high precision and a dose-dependent controllable effect.”
“The FDA may appreciate the fact that cannabis is being used for self-medication through most of the United States, creating a significant need to have a safe and effective means to inhale cannabis and return to the workforce. By expediting the examination of solutions such as Syqe, the FDA may promote safe smoke-free treatment that can also prevent unintentional overdosing,” Syqe tells NoCamels.
Syqe has raised over $80 million to date from investors including OurCrowd, and Israeli private equity firm Shavit Capital Fund.