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Turing receives no objection letter from Health Canada to start TUR-002 program clinical study

Turing Pharmaceuticals has received a No Objection Letter from Health Canada to initiate the first clinical study for its TUR-002 program.

Ketamine, which has been extensively used as an intravenous anesthetic for many years, has been also reported to be effective as a rapid treatment for a variety of mood and anxiety disorders. These studies suggest that ketamine infusions can also rapidly reduce suicidal ideations.

Turing is developing TUR-002, an intranasal formulation of ketamine for the treatment of suicidality. According to the Centers for Disease Control and Prevention (CDC) there were over 40,000 deaths by suicide and close to 500,000 patients treated for self-inflicted injuries in 2013 in the United States.

Turing plans to complete the phase I trials for TUR-002 in the first half of 2016 in Canada and initiate pivotal registration trials in the middle of 2016 in North America and Europe.

University of Pennsylvania professor of Psychiatry at the Perelman School of Medicine Michael Thase said: "Suicide is one of the world’s great public health problems and acute suicidality is a life-threatening crisis that affect thousands of people every day. Effective treatments that rapidly address suicidality are urgently needed."

Turing president of research and development Eliseo Salinas said: "I am very impressed with the progress Turing’s R&D team has made in a very short time frame advancing intranasal Ketamine for the treatment of suicidality."