Tetra Bio-Pharma announced Health Canada re-classified the inhalation pipe device used in the delivery of its PPP001 cannabis drug to a class 2 medical device.
Tetra Bio-Pharma (TSXV:TBP) announced Health Canada re-classified the inhalation pipe device used in the delivery of its PPP001 cannabis drug to a class 2 medical device.
As quoted in the press release:
The reclassification will help pave the way towards reimbursement for patients; a key element to patient access and care. The significance of this decision is such that if PPP001 is approved by Health Canada, both the prescription drug and the inhalation device will be eligible for insurance coverage by private and provincial public insurance plans. Tetra Bio-Pharma is undertaking a Phase III trial with PPP001 treating late stage cancer patients looking to improve quality of life and reduce pain. The Company also recently announced it is starting a head to head trial to investigate cannabis versus Fentanyl in managing breakthrough cancer pain.
“We are very excited by the reclassification as we believe it will provide patients with a financial benefit in terms of coverage for the device and prescription drug,” stated Dr. Guy Chamberland, Ph.D., Interim CEO and CSO at Tetra Bio-Pharma. “Many cancer patients rely on private and public insurance plans for access to their medication. This decision by the Government of Canada is an important step forward to facilitating access to cannabis drugs. This coupled with our robust clinical trial program and the evidence we are establishing will support physicians in discussing and recommending this option with their patients.”