Shares of Avanir Pharmaceuticals (AVNR) gained a massive 85.31% to close the trading session on Sep 15 at $12.49. The jump came on the back of encouraging data from a phase II study (n=220) on Avanir‘s AVP-923, which evaluated the safety, tolerability and efficacy of the candidate for treating agitation associated with Alzheimer’s disease.
Data revealed that agitation was significantly reduced in patients treated with AVP-923 compared to those in the placebo arm, thereby meeting the primary end point of the 10-week multicenter and randomized study. Agitation was measured by the agitation/aggression domain score of the neuropsychiatric inventory (NPI).
Furthermore, improvements with respect to key secondary endpoints of the study such as the total NPI score, clinical global impression of change-agitation, patient global impression of change and measures of caregiver burden were also revealed. The candidate was well tolerated in the study.
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Encouraged by the positive results on AVP-923, Avanir intends to meet the FDA and EMA to discuss the commencement of a pivotal program in the above indication.
Successful development and subsequent commercialization of the candidate for the indication would be highly welcomed by patients and doctors alike since agitation associated with Alzheimer’s disease currently has no FDA approved treatments.
We believe that this was the primary reason behind the massive stock price appreciation at Avanir following the phase II data. We expect investor focus to remain on updates regarding AVP-923 in the above indication. Avanir is also evaluating AVP-923 for treating levodopa-induced dyskinesia in patients with Parkinson’s disease.
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Avanir’s shares shot up on positive data from a phase II study conducted with AVP-923 for the treatment of agitation in patients with Alzheimer’s disease. Considering the lack of FDA approved drugs for the treatment of agitation in Alzheimer’s disease, there could be significant demand for AVP-923 once it is approved. The next step in the development process involves a meeting with the regulatory agencies to determine the advancement of the candidate into pivotal studies.
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