Tetra Bio-Pharma is planning a Phase 2 clinical trial to test its PPP001 vaporized medical cannabis product as a treatment for pain in patients with fibromyalgia.
This follows the positive results of a Phase 1 trial in healthy volunteers, which demonstrated that the investigational product is generally safe and well-tolerated, the company announced.
The company successfully completed the trial, which explored the safety of PPP001, as well as its stability and distribution in the body. It was conducted in the United States and Canada, and enrolled 12 healthy volunteers who received increasing doses of PPP001 for four days followed by a single dose of vaporized PPP001.
Interim analysis of the clinical data has provided a deeper understanding of the process of administering cannabinoids to patients. The information may help health regulators decide the best strategies in the future for patients with chronic pain.
“We are thrilled with the results of this trial which was completed both on time and on budget,” Guy Chamberland, PhD, CEO and chief scientific officer of Tetra Bio-Pharma, said in a press release. “We look forward to investigating this vaped version of PPP001 in patients who suffer from the debilitating pain of fibromyalgia.”
The positive effects of cannabis and cannabis-derived substances to alleviate pain and other conditions have been previously documented.
PPP001 is an inhaled medical cannabis product that is currently being explored in clinical trials to manage pain in patients with advanced cancer.
In July 2018, Tetra announced a collaboration with Storz & Bickel to explore the potential of medicinal cannabis PPP001 vapor delivered by the Mighty Medic — the first certified battery-powered medical herbal vaporizer.
Vaporized delivery provides an alternative to smoking cannabis and cannabis-derived substances. Additionally, it could represent an alternative to opioid use for patients who have chronic pain conditions, such as fibromyalgia.
“The Mighty Medic technology provides an alternative delivery method for PPP001, along with a new therapeutic indication for fibromyalgia which will give us access to a much larger patient population,” Chamberland said. “According to the National Fibromyalgia Association there are more than 10 million people who suffer from this disease in the U.S. alone.”
The positive safety results from the Phase 1 trial on vaporized PPP001 are expected to support the start of the new Phase 2 trial in patients with fibromyalgia.