Alcobra axes ADHD drug after Phase 3 failure

pharmafile | January 18, 2017 | News story | Research and Development ADHD, Alcobra, metadoxine 

Israeli-based firm Alcobra is to pull the plug on its experimental attention deficit hyperactivity disorder (ADHD) drug metadoxine after it failed to show any efficacy over placebo in a Phase 3 trial, wiping 50% from the company’s value.

Using the Conners’ Adult ADHD Rating Scales (CAARS) as a reference point, top-line results from the trial indicated that the drug was no better than placebo at managing symptoms of the illness, with Alcobra announcing that it has no plans to continue its development. President and chief executive Dr Yaron Daniely stated: “We consider the negative findings of the study to be conclusive…We are exceedingly disappointed with these top-line results.”

Daniely stated in a conference call that the company now plans to conduct a full data review in order to provide direction to investors in the coming weeks with a new strategic plan.

The same trial was also interrupted by the FDA in September 2016 after it was reported that metadoxine potentially caused damage to peripheral nerve function in animal studies. The FDA later lifted its hold on the trial in December.

Matt Fellows

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