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

Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.