Updated from 6:38 am ET with additional information.
TEL AVIV (TheStreet) -- Treatment with an experimental formulation of vitamin B6 known as MDX failed to improve the symptoms of attention-deficit hyperactivity disorder compared to placebo, according to phase III study results announced by the developer of the drug, Alcobra (ADHD) , in a statement issued Monday.
However, when Alcobra removed four placebo patients from the analysis because of "extreme" responses, the MDX benefit in the adult ADHD was positive and statistically significant, the company said.
Investors weren't buying the spin. Alcobra shares are down 47% to $7.47 in Monday trading. What's wrong with just excluding some patients and claiming victory? Think about it this way: If baseball statisticians ignored all of Derek Jeter's outs, he batted 1.000 during his major league career. Alcobra is doing the same thing with the MDX study analysis and it doesn't smell right, either.
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The study enrolled 300 patients with adult ADHD and randomized them to treatment with MDX or a placebo for six weeks. The primary endpoint was the change from baseline in the CAARS-INV, a widely accepted clinical measure of the presence and severity of ADHD symptoms, used in past to win approval of ADHD drugs.
Alcobra did not provide details about the primary analysis of the intent-to-treat patient population, except to say there was a non-statistically-significant trend favoring MDX over placebo when assessed by the CAARS-INV scale. The company did not break out results according to the two major subtypes of ADHD -- primary inattentive type and combined type.