Alcobra admits trial result "not statistically significant"

//Alcobra admits trial result "not statistically significant"

Alcobra admits trial result "not statistically significant"

By | 2014-10-25T19:26:31+00:00 October 25th, 2014|Business|0 Comments

The share price of Alcobra (ADHD) is falling steeply, currently down 23.75%, after the company issued a clarification about the clinical trial the results of which were published recently. The company acknowledges that the results of the trial of its drug MDX for treating Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome were not statistically significant.

“While a complete ITT analysis by ADHD subtypes is still ongoing and was not presented at AACAP, the magnitude of symptom improvement appears to be similar in all subtypes, and the Predominantly-Inattentive ADHD (PI-ADHD) subtype alone did not produce a statistically significant outcome,” the company’s statement said.

Two weeks ago, Alcobra’s share price plummeted after the stock market was disappointed by the results of the company’s Phase III study of MDX. The company still maintains that further testing of MDX is justified. “The efficacy signal along with the safety and tolerability profile observed with MDX to date, support the continued development of MDX and its potential as an important addition to available therapies for ADHD,” said Dr. Jonathan Rubin, Chief Medical Officer of Alcobra, who added, “It will be important to design the next Phase III study of MDX to better address the high placebo response and large variability observed in this trial. We are confident that we can put such measures into place.”

Published by Globes [online], Israel business news – www.globes-online.com – on October 23, 2014

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