With approval from the Independent Ethics Board, and a Health Canada submission in the works, Tetra Bio-Pharma and its co-develoment partner Storz & Bickel are quickly advancing plans to commercialize a new cannabis drug and specially designed vaporizer to treat fibromyalgia.
A phase-one clinical trial will be conducted after Tetra identifies every compound in the vapor from its PPP001 drug later this month.
Development costs and time to market will be “significantly reduced,” as the clinical trial data and vapor-compound information comes in, the company said.
“The clinical study will allow Tetra to accelerate bringing PPP001 for fibromyalgia patients,” said CEO and chief scientific officer Dr. Guy Chamberland. “The Independent Ethics Board approval represents a major step forward prior to obtaining approval from Health Canada.”
A groundbreaking study published in the Journal of Clinical Rheumatology found that cannabis treatment dramatically improved pain control and quality of life for a group of patients suffering fibromyalgia.
All of the patients reported a significant improvement in every parameter, after starting cannabis treatment, according to the article “Medical Cannabis for the Treatment of Fibromyalgia.”
The study found that approximately 50 per cent stopped taking any other medications for fibromyalgia.
Tetra’s co-development partner Storz & Bickel built the first factory in the world for the manufacture of medical herbal vaporizers in Tuttlingen, Germany, a town with almost 500 medical device manufacturers. Tuttlingen is reputed to be the centre of medical technology, where the first factory to produce surgical instruments was established more than 150 years ago.