Alcobra's MDX flunks late-stage study in adults with ADHD; shares plummet 54%

• Alcobra (ADHD -54.2%) is getting roughed up in early trading in response to its announcement that its second Phase 3 clinical trial, MEASURE, assessing lead product candidate Metadoxine Extended Release (MDX) in adults with Attention Deficit Hyperactivity Disorder (ADHD) failed to beat placebo.
• CEO Yaron Daniely says, "We are exceedingly disappointed with these top-line results. In the coming weeks, the Company intends to review the full data set from MEASURE. Consequently, we will evaluate our options and communicate our strategic plan to investors."
• MDX is a modulator of GABA (gamma-aminobutyric acid), an abundant neurotransmitter in the central nervous system, especially in the cerebral cortex where thinking occurs and sensations are interpreted. It is also being developed for Fragile X syndrome.
• The FDA placed the MDX program under full clinical hold in October over concerns about potential neurological side effects.
• Previously: Alcobra receives written notice from FDA on MDX clinical hold; more human safety data needed (Oct. 7, 2016)