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Study to Test Cannabis in Head-to-Head Trial with Fentanyl to Find Alternative for Severe Pain

Study to Test Cannabis in Head-to-Head Trial with Fentanyl to Find Alternative for Severe Pain
As a means of addressing the opioid crisis, this clinical trial will be the first to compare cannabinoids to fentanyl for breakthrough pain relief.

In a world first, cannabis-based drugs are being compared to fentanyl as an alternative to breakthrough pain.

The clinical trial is being facilitated by Santé Cannabis, an independently credentialed research organization based out of Montreal. The study will compare the effects of cannabinoids produced by Tetra Bio-Pharma, a biopharmaceutical leader in cannabinoid-based drug discovery and development, in comparison to fentanyl, an opioid that is linked to hundreds of accidental overdoses in Canada.

According to a statement from Tetra, there were at least 2,923 apparent opioid-related deaths between January and September 2017. Of these overdoses, 92% were accidental and 72% of them involved fentanyl or fentanyl analogues.

Fentanyl is used as a treatment for "breakthrough pain": a specific kind of "severe pain that erupts while a patient is already medicated with a long-acting painkiller." This usually occurs in connection with cancer.

The National Institute of Drug Abuse have called the opioid's misuse a "crisis" that needs to be addressed.

"Patients suffering from breakthrough pain require fast relief. Overdosing from fentanyl may occur in patients who exceed the recommended dosage in the hope of obtaining a more rapid relief. The development of a THC-based alternative would help provide a safer option to these patients and help prevent overdosing on fentanyl," said Dr. Antonio Vigano, an attending physician and professor at McGill University and the Research Director of Santé Cannabis where he is a Principal Investigator in a Phase 3 clinical trial for pain associated with advanced cancer, in addition to a phase 2 trial for chronic pain.

"[The PPP001 drug] has the potential to become the long-awaited alternative to opioids for the management of breakthrough pain in cancer patients. Through this trial, we are going to gather more evidence-based data on the safety, efficacy, and ease of administration of inhaled cannabinoids as the complementary therapy of choice for cancer-related pain." said Dr. Vigano.

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