Alcobra Loses Focus in ADHD Trial for FDA Approval
Cognitive disorders, specifically Attention Deficit Hyperactivity Disorder (ADHD), are prevalent within the United States and affect 5% of children. Around half of these children will continue to have ADHD as adults, according to the American Psychiatric Association in 2013. Alcobra Ltd. (NASDAQ: ADHD) focuses on adult ADHD and recently posted news of an FDA trial regarding this, but investors could find this distracting. After all, what does a stock price drop of 50% or so in one trading session tell you?
The trial was a 300-patient, randomized, placebo-controlled study and it was conducted at 18 sites in the United States and two in Israel. Approximately 70% of patients were enrolled in the United States, with a nearly even split between men and women. Patients were randomized to receive either 1,400 mg of MDX or a placebo over six weeks. The primary endpoint was the Conner’s Adult ADHD Rating Scale (CAARS-INV), it has been utilized in registration studies for other approved ADHD drugs.
MDX, as well as the placebo, were well tolerated by the patients. The adverse events that were reported from both groups were similar. But this seems to be in line with the results from the trial. Adam Feuerstein, from TheStreet, explained that Alcobra removed four placebo patients from the analysis because of “extreme” responses.
Dr. 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.
At the opening bell, Alcobra shares gapped down to $7.91. Since the open, shares traded down about 50% to $7.07 in the first two hours of trading. The range on the day is $6.56 to $8.00.
The company has — or at least had — a consensus price target of $33.63 and a 52-week trading range of $6.56 to $26.86. Its market cap is roughly $99 million.