Alcobra shares fall on Phase III results of ADHD drug

Shares of Israeli emerging biopharmaceutical company Alcobra (Nasdaq: ADHD) lost nearly half their market value after the company announced topline results from a Phase III study of metadoxine extended release (MDX) in adults with ADHD (attention deficit hyperactivity disorder). Shares fell up to 53% to a low of $6.57.

In a modified Intent To Treat (mITT) population (n=293), MDX demonstrated a statistically-significant improvement in ADHD symptoms compared to placebo as measured by the Conner's Adult ADHD Rating Scale (CAARS-INV) (p < 0.03). The company said the mITT population was derived by a post hoc exclusion of four subjects with extreme placebo responses while the ITT analysis before exclusion yielded a “positive trend” (p=0.15; n=297).

Jonathan Rubin, Alcobra's chief medical officer, said: “We conducted the mITT analysis after observing the disproportional effect of a few extremely large placebo responses which were inconsistent with what has been reported in previous ADHD trials of MDX or other agents. We plan to take the complete findings of this and other MDX studies to the FDA to determine the next steps on the path to potential regulatory approval for MDX."