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AVNR NEWS- Avanir Pharmaceuticals Inc. (AVNR) said the new low-dose version of neurological disorder pill Zenvia was safe and tolerable by patients with multiple sclerosis and ALS over a trial period.
Shares rose 4.8% in pre-market trading to $3.25. The stock was around 50 cents a year ago.
The Food and Drug Administration told Avanir several years ago to reformulate and retest Zenvia because of safety worries. The drug treats pseudobulbar affect, episodes of uncontrollable laughing or crying suffered by people with multiple sclerosis, Alzheimer's disease and other neurological disorders.
"The new lower-dose formulations of Zenvia have maintained statistically significant and clinically meaningful efficacy while providing an improved safety and tolerability profile relative to the original higher dose formulation," Chief Medical Officer Randall Kaye said.
The company plans to file its full response with the FDA within the next few weeks and expects an approval decision on the drug by the end of the year.