Concert's spasticity drug gets out from under an FDA hold

The 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