Dr. Shapira's Chicago Headache Blog

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Saturday, December 26, 2009

Addex Pharmaceuticals ends migraine prevention study due to live damage.

The problem with drug therapy for migraines and tension-type type headaches is advers drug effects. This current study was discontinued to a higher than expected amount of liver disorders in patients. The company stated "abnormalities of liver function tests that is higher than expected in this population." Previous studies with this drug had not shown this problem.

the drug being tested ADX10059 is a metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator (NAM). It is thought that glutamate overstimulation may to contribute via different mechanisms to pathology in both migraine and GERD. The drug ADX10059 has been shown in clinical studies to reduce symptoms of acute migraine and, separately, to reduce reflux and GERD symptoms.

It is assumed the company will retest or reexamine liver function to see if problems were missed on previous studies.

The problems began showing up at day 28 and increased progressively over time. If the problems showed up later such as after 3 months they may never have been found as the study onlyy covered 90 days of treatment.

posted by Dr Shapira at 9:54 AM

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