Let’s hope this marks a pivot that sticks: The ever-controversial Turing Pharmaceuticals just announced it’s received an IND and blessings from the Food and Drug Administration to fast track its experimental epilepsy drug.
The company’s news release comes right on the heels of an announcement from San Diego-based Imprimis Pharmaceuticals that it’d soon commercialize a steeply discounted alternative to Turing’s contentious generic drug, Daraprim.
Turing will kick off a Phase 1 study of TUR-004 to evaluate the drug’s safety and tolerability in treating epileptic encephalopathies. The trials are slated to take place in Switzerland. Turing has 13 drug candidates in its development pipeline, and two that are on the market – including Daraprim.
“With our first investigational candidate moving into the clinic, this is a very exciting moment at Turing Pharmaceuticals,” CEO Martin Shkreli said in a statement. “We are pleased that FDA has granted Fast Track status for TUR-004 providing for an accelerated development and regulatory pathway.”
Surprisingly stiff language for a CEO with a reputation for mouthing off, but perhaps this is a sign that the company is finally making efforts to stay afloat.
Toxoplasmis drug Daraprim, one of Turing’s flagship generic drugs, has been the center of a national onslaught since Shkreli bumped its price 5,000 percent to $750 per pill. Imprimis has cut down the price of a similar formulation to about $1 a pill.
