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February 7, 2013
08:36 EDTAVNRAvanir Pharmaceuticals announces positive interim data from study with AVP-786
Avanir Pharmaceuticals announced that it has successfully completed the first of a two-stage pharmacokinetic study with AVP-786, a drug product containing a deuterium modified form of dextromethorphan. Based on interim data, Avanir believes that it has identified a formulation of AVP-786 with a comparable pharmacokinetic, safety and tolerability profile to AVP-923. The company has requested a meeting with the FDA to discuss the full development path for AVP-786. Avanir also announced today that the company intends to modify the enrollment target of its ongoing phase II clinical study of AVP-923 in central neuropathic pain in multiple sclerosis to 200 patients. As a result of this change, the company now expects to have data from the PRIME study in the fourth calendar quarter of 2013.
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September 22, 2015
11:51 EDTAVNRAvanir reports JAMA publication of AVP-923 study results in Alzheimer's disease
Avanir Pharmaceuticals announced that results from a phase II study evaluating the efficacy and safety of AVP-923 for the treatment of agitation in patients with Alzheimer's disease were published today in the Journal of the American Medical Association. The study showed that patients with moderate to severe agitation secondary to Alzheimer's disease who were treated with AVP-923 had a clinically meaningful and statistically significant improvement measured by the agitation/aggression domain of the Neuropsychiatric Inventory, compared with patients treated with placebo. The treatment effect with AVP-923 was evident by week one and remained significant at the end of the 10-week study. Additionally, statistically significant clinical effects were observed with AVP-923 across the majority of secondary endpoints, including the NPI total score, clinical global impression of change-agitation, patient global impression of change and measures of caregiver burden. AVP-923 was shown to be generally well tolerated in this elderly population that also received multiple concomitant medications during the study period. Treatment-emergent adverse events were consistent with the known safety profile of AVP-923. The most common adverse events were falls, diarrhea, and urinary tract infection occurring in less than 10% of patients.

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