FDA Lifts Hold on Cortex Drug

Cortex Pharmaceuticals Inc. shares rose 9% on Monday after the Irvine-based company said U.S. regulators had approved the resumption of clinical trials on a compound designed to help people stay awake.

The Food and Drug Administration told Cortex on Friday that the agency had lifted a hold placed almost seven months earlier on trials of the company’s ampakine CX717 compound, Cortex said.

The delay in the stay-awake study disrupted Cortex’s plans to find a partner to market the compound for treatment of attention deficit hyperactivity disorder, or ADHD, an indication that it was far along in human trials, said Elemer Piros, an analyst at Rodman & Renshaw Inc. in New York.

“You can sort of gauge the interest from the pharmaceutical industry in a compound that has a friendlier label for ADHD,” Piros said. “You don’t want to feed millions of Americans with stimulants and derivatives if you have a choice. Cortex may provide that alternative.”

If approved, the drug probably wouldn’t be subject to regulation by law enforcement agencies because it isn’t a stimulant, Piros said.

Cortex shares rose 28 cents to close at $3.39, after touching $3.81 earlier in the day. The company’s shares had risen 35% this year through Friday.

The company made a commitment to use FDA-specified doses in the wakefulness trials, the statement said. Cortex also plans to have more extensive toxicological information available after a three-month study in monkeys and rats is completed this year, the company said.

Cortex’s products in development are all from the ampakine family of compounds, which is said to boost the function of a neurotransmitter called glutamate. When that improves, brain cells can carry signals more effectively, potentially helpful in treating ADHD, the company said.

The company said the drug might also be used to treat patients with memory and cognition problems, autism, Alzheimer’s disease, schizophrenia and depression.