TEL AVIV, Israel, July 1, 2020 /PRNewswire/ -- Israeli med-tech company Syqe Medical has conducted the first clinical trial to demonstrate that extremely low and precise doses of inhaled THC – the principal psychoactive constituent of cannabis – can effectively relieve pain, while avoiding the common side effects associated with cannabis use.
The study, published in the European Journal of Pain, is 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. Although widely championed, until now there has been scarce scientific evidence to support or even fully explore claims of microdosing benefits and safety. The placebo-controlled, double-blind, multi-dose study was conducted at Rambam Medical Center in Israel and examined blood THC levels, pain relief, cognitive functions and psychoactivity.
The study shows that an optimally effective dose to relieve pain is just 500 micrograms of THC. Syqe patients consume 3-4 inhalations per day, each up to 500 micrograms. A typical medical cannabis patient consumes 1 gram of 15% THC cannabis per day, which contains 150,000 micrograms of THC. This illustrates a key finding from the study that patients can benefit from dramatically lower doses.
The Syqe Selective-Dose Inhaler, the company's novel drug delivery platform marketed in Israel by pharmaceutical giant Teva, allows physicians and patients to select microgram-level doses with unprecedented precision. These results are presumed to be due to the bioavailability-enhancing technologies of the Syqe platform in conjunction with its first in class selective-dosing capabilities. CE approval in Europe is pending. Syqe believes that the published study and the actual patient use data in Israel will be an important part of its planned FDA submission in the U.S.
"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 drug will be needed, resulting in fewer side effects and an overall more effective treatment. The Syqe drug delivery technology is also applicable to opioids and other compounds that, while potentially effective, are notoriously associated with dangerous side effects. 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," said Perry Davidson, Syqe Medical CEO.
These findings may allow the establishment of a long-awaited industry milestone: a standardized therapeutic window for cannabis inhalation. By provably administering precise doses measured in micrograms and quantifying diminishing therapeutic returns versus increased psychoactivity, the study was able to document successful pain relief while minimizing potentially debilitating psychoactive side effects.
"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. 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," said Prof. Elon Eisenberg, lead researcher and Dean of the Faculty of Medicine at the Technion-Israel Institute of Technology.
The Syqe Selective-Dose Inhaler allows for precise specification and personalization of cannabis treatment protocols that can be evaluated using accepted pharmaceutical practices, paving the way to increased research, applications, standards, acceptance and global usage of medical cannabis, and other drugs that may benefit from high-resolution drug delivery.
"Syqe Medical is a trailblazer in the field of medical cannabis by means of accurate microdosing utilizing the proprietary Syqe inhaler. We believe that the Syqe inhaler solves many of the safety, efficacy and regulatory issues regarding medical cannabis and we look forward to future positive developments from the company," said Dr. Morris Laster, Medical Venture Partner at OurCrowd, an investor in Syqe.
ABOUT SYQE MEDICAL
Syqe Medical is a med-tech company developing technologies that enable precise delivery of a wide range of therapeutic molecules by inhalation. Its flagship product, the Syqe Inhaler™, is the first of its kind medical device to provide predictable, precise, and consistent treatment at pharmaceutical standards. Unlike traditional inhalers, Syqe's breakthrough drug delivery technology introduces precision dose control, accurate electronic selective dosing, inhalation automation that ensures bioavailability with natural inspiration, and remote clinical monitoring. Utilizing this breakthrough technology, Syqe aims to relieve the suffering of as many patients as possible in the fastest possible way. First brought to market for use with medical cannabis, Syqe is exploring numerous molecules for a variety of therapeutic areas including - but not limited to - pain, CNS disorders, sleep, anxiety, and cancer.
Syqe was founded in 2011 and is headquartered in Tel Aviv, Israel with offices in New York and Canada. Approved by the Israeli Ministry of Health, the Syqe Inhaler™ is currently marketed by Teva Pharmaceuticals in Israel. For more information, visit www.syqemedical.com
PRESS CONTACT: Leah Stern, Vice President OurCrowd Communications / +44 747 019 68226 / [email protected]
SOURCE Syqe Medical