ZUG, Switzerland, Oct. 5, 2015 /PRNewswire/ -- Turing Pharmaceuticals AG, a privately-held biopharmaceutical company focused on developing and commercializing innovative treatments for serious diseases and conditions, today announced that an Investigational New Drug Application (IND) for TUR-004 was submitted to the United States Food and Drug Administration on Tuesday, September 22, 2015.
TUR-004 is intended for use as an adjunctive therapy for refractory generalized seizures in patients with epileptic encephalopathies. The first study in the clinical program will be a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of an oral formulation of TUR-004 in healthy adult subjects.
"We are excited about the potential use of TUR-004 for helping people with this severe form of epilepsy," said Eliseo Salinas, M.D., MSc, President of Research and Development. He added, "We feel very strongly that clinical studies of TUR-004 will lead to the availability of TUR-004 and help to improve patients' lives."
Individuals with epileptic encephalopathies face a higher incidence of sudden unexplained death, status epilepticus and severely diminished quality of life. Epileptic encephalopathies are a diverse group of severe epilepsy disorders in which uncontrolled epileptic activity contributes to a progressive decline in cognitive and motor function.
Martin Shkreli, founder and CEO of Turing Pharmaceuticals said, "TUR-004 is the first of multiple investigational new drug applications we expect to file in the next twelve months as a result of our focused research and development programs."
Turing Pharmaceuticals AG is a privately-held biopharmaceutical company with offices in Zug Switzerland and New York, New York. Turing focuses on developing and commercializing innovative treatments for serious diseases and conditions across a broad range of therapeutic areas, for which there are currently limited or no treatment options. Products being developed include intranasal ketamine for a variety of mood disorders and Syntocinon(r) (oxytocin nasal solution) for multiple indications. Daraprim (pyrimethamine) for the treatment of Toxoplasmosis in combination with sulfonamide and Vecamyl(r) (mecamylamine HCl tablets) for hypertension are Turing's first commercial products.
For more, visit www.turingpharma.com.