Avanir Pharmaceuticals, Inc.
) Nuedexta (AVP-923) was launched in the U.S. in Feb 2011 for the
treatment of pseudobulbar affect (PBA). Net Nuedexta revenues
grew 15.2% sequentially to $19 million in the third quarter of
fiscal 2013 (ended Jun 30, 2013).
In Jun 2013, Avanir received approval for Nuedexta in the EU
for the treatment of patients suffering from PBA. The marketing
application was based on comprehensive data from phase III
studies of Nuedexta in patients with PBA, plus data from
longer-term safety studies.
Avanir is looking to expand the label of Nuedexta into
additional indications. Earlier in the month, Avanir announced
the commencement of enrollment in a phase II proof-of-concept
study (AVR-133) on Nuedexta for the treatment of levodopa induced
dyskinesia (LID) in patients suffering from Parkinson's disease
AVR-133 - a double-blind, randomized, crossover study - will
compare Nuedexta with placebo for the treatment of LID. The study
will enroll 16 PD patients. The patients will be treated with
Nuedexta and placebo for 14 days each separated by 2 weeks.
Avanir expects to report top-line data from AVR-133 in the
second half of calendar 2014.
This drug is being studied for two other indications, namely,
agitation in Alzheimer's disease (phase II), and central
neuropathic pain in multiple sclerosis (phase II).
The PRIME study is conducted to evaluate the efficacy of
Nuedexta for the treatment of central neuropathic pain in
multiple sclerosis. Avanir expects to report top-line data from
the study by year end.
Avanir currently carries a Zacks Rank #3 (Hold). Currently,
Isis Pharmaceuticals, Inc.
) look more attractive with a Zacks Rank #1 (Strong Buy).
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