Industry Briefs

FDA Issues Hold on Phase 3 Trial of Extended-Release Metadoxine for ADHD

Alcobra Ltd. announced last month that the Food and Drug Administration (FDA) has placed a clinical hold on its trial of the extended-release formulation of metadoxine (MDX) for the treatment of attention-deficit/hyperactivity disorder (ADHD) and Fragile X syndrome. The hold will immediately impact a phase 3 trial of MDX in adult patients with ADHD—known as the “MEASURE” study—which has enrolled nearly 500 patients to date.

“The FDA indicated in the letter that the clinical hold was placed due to electrophysiological neurologic findings in previously submitted long-term animal studies with metadoxine,” according to a company press release. “The FDA letter did not reference any clinical safety data observed in the MEASURE study or in previous human studies with MDX.”

Chicago May Require Additional Licensing of Pharma Reps

As part of an effort to fight prescription opioid abuse, Chicago Mayor Rahm Emanuel announced earlier this month that the city is considering steps to establish additional licensing requirements for pharmaceutical representatives.

Similar to licensing requirements in Washington, D.C., pharmaceutical reps would be required to receive continuing education and maintain documentation of communications with health care professionals and their representatives, according to a press release from the Mayor Emanuel’s office. ■