Alcobra tumbles on Phase III ADHD results for metadoxine
This article was originally published in Scrip
Alcobra's stock value was cut in half and then some on 6 October after the company revealed highly anticipated results from the first Phase III clinical trial for extended-release metadoxine (MDX) in the treatment of attention deficit hyperactivity disorder (ADHD).
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Failing to meet the primary endpoint in its second Phase III study in adult ADHD, the Israeli firm confirms there is no path forward in that indication. Developing MDX for Fragile X syndrome and business development options are under consideration.
After accelerated approval in the US in April based on Phase II response rates, the company will seek full approval later this year based on a tripling of progression-free survival in a Phase III trial.
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