Turing Pharmaceuticals, and Martin Shkreli in particular, have both been hit hard with very direct criticism surrounding the financial incentives within increasing costs for drugs without much effort or financing going toward new drug development.
But the timing couldn’t be much better for the company as it has announced it submitted an investigational new drug application for TUR-004 – a therapy designed to be a supplemental treatment for those who suffer from seizures as a result of epileptic encephalopathies.
The submission to the FDA took place last month and will be the next step moving forward to a clinical study, which will be a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of an oral formulation in healthy adult subjects.
Obviously this wouldn’t be big news for most pharmaceutical companies, at this stage, but considering the spotlight put on Turing recently and the doubt many have in its ethical basis, this could be considered notable news.
This new treatment apparently isn’t the only therapy in the works for Turing.
“TUR-004 is the first of multiple investigational new drug applications we expect to file in the next 12 months as a result of our focused research and development programs,” Shkreli said in a statement. An early-stage ketamine product that could treat mood disorders is also reportedly in the works.
Photo: Flickr user StockMonkeys
