NEWS
Concert's spasticity drug gets out from under an FDA hold
FierceBiotech
2014/07/16The FDA has lifted a partial clinical hold on Concert Pharmaceuticals' ($CNCE) treatment for spasticity, allowing the biotech to resume dosing in a Phase I trial. The drug, CTP-354, is designed to treat involuntary muscle contractions in patients with multiple sclerosis or spinal cord injury. The FDA had suspended Concert from administering the drug at volumes over 6 mg per day, citing toxicology concerns. With the hold removed, the biotech intends to start dosing at 12 mg per day in the third quarter, resuming the escalating trial. More
Summary
The FDA has lifted a partial clinical hold on Concert Pharmaceuticals' treatment for spasticity, allowing the biotech to resume dosing in a Phase I trial.