Sustained Therapeutics announced that it received regulatory approval in Canada to begin a Phase II trial of its novel pain medication.
Vancouver, BC-based Sustained Therapeutics develops a long-lasting non-opioid pain medication. Its trial evaluates a sustained-release platform technology to aid in chronic pain treatment.
The company said in a news release that it designed the medication to relieve both acute and chronic pain. It does so over longer periods with fewer side effects than the current standard of care, Standard Therapeutics said. The company’s Phase I trial resulted in a reduction in pain scores for three-quarters of participants. It found that effects lasted up to four weeks from a single dose, the company said.
Sustained Therapeutics received a no objection letter (NOL) from Health Canada to move forward with a five-center study. This study covers chronic pain as the company already has another Phase II trial underway for acute pain. Both trials use the sustained-release technology.
“The NOL from Health Canada is a clear indication that our clinical work is heading in the right direction,” said Dr. Martin Gleave, Sustained Therapeutics founder and CMO. “We’ve got a green light to start our next clinical trial and we expect patient enrollment to begin in the first quarter of 2023. This study will evaluate whether this treatment beats the current standard of care.”