Industry briefs

Alcobra’s ADHD Medication for Adults Fails in Late-Stage Study

Alcobra Ltd announced on Tuesday that its experimental medication metadoxine extended release (MDX) failed to significantly reduce symptoms of attention-deficit/hyperactivity disorder (ADHD) in adults.

Analysis of the data from the phase 3 trial of 283 patients revealed that MDX did not meet the primary endpoint of demonstrating a statistically significant difference from placebo in the change from baseline as measured using the Conners’ Adult ADHD Rating Scales, the company reported.

The announcement comes after the Food and Drug Administration (FDA) in September placed a clinical hold on MDX after a review suggested an association between the drug and “adverse neurological findings” in preclinical trials. According to a company press release, MDX was found to be generally well tolerated in the phase 3 trial.

FDA Approves Long-Acting Opioid With Abuse-Deterrent Properties

Earlier this month, the FDA approvedArymo ER—an extended-release morphine tablet—for “the management of severe pain requiring daily, around-the-clock, long-term treatment, for which alternative treatment options are inadequate.”

While the agency approved drug maker Eaglet Corp.’s claim that the physical and chemical properties of Arymo ER make abuse of the medication by injection difficult, it did not approve claims that the drug deters abuse by oral and nasal routes.

In August 2016, an FDA advisory committee recommended approval of the medication with abuse-deterrent labeling.

The commercial launch of Arymo ER in the United States is planned for the first quarter, according to a press release. ■