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Avanir diabetic pain drug study meets goal, shares up

Tue May 27, 2008 11:24am EDT

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(Reuters) - Avanir Pharmaceuticals (AVNR.O) said a study of its drug candidate, Zenvia, for treating diabetic peripheral neuropathic pain achieved its goal of identifying an alternative dosing formulation that would be safer and more tolerable than previous versions, sending its shares up 12 percent.

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Diabetic peripheral neuropathic pain affects some diabetes patients and is a condition where damaged nerves can alter the sensitivity of pain centers in the spinal cord.

The pharmacokinetic study -- which determines how a body absorbs the drug into the system -- of Zenvia identified a lower-dose quinidine formulation intended to deliver similar efficacy and improved safety and tolerability compared with formulations previously tested for this indication.

Quinidine is used to treat abnormal heart rhythms and works by making the heart more resistant to abnormal activity.

"Notably, the new formulation of Zenvia offers a lower overall exposure to quinidine which should improve the cardiovascular risk profile," Randall Kaye, Avanir's chief medical officer, said.

No serious adverse events were reported in the study, the company said. The most common adverse events were dizziness, headache, nausea, diarrhea and drowsiness.

Zenvia is also the subject of a late-stage study for the treatment of involuntary emotional expression disorder, or pseudobulbar affect, under a special protocol assessment agreement with the U.S. Food and Drug Administration.

Shares of Aliso Viejo, California-based Avanir rose to a high of $1.33 in morning trade Tuesday on Nasdaq.

(Reporting by Aradhana Aravindan in Bangalore; Editing by Pratish Narayanan)



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