Acorda Therapeutics, Inc.
) recently announced data from a phase I study evaluating its
epilepsy candidate, diazepam nasal spray. The company is
developing diazepam nasal spray for treating epilepsy patients
who experience cluster seizures/acute repetitive seizures. The
data was presented at the 65th annual meeting of American Academy
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The open-label crossover phase I study, which enrolled 24 healthy
volunteers compared the use of a single dose of 20 mg diazepam
nasal spray with a single dose of 20 mg diazepam rectal gel.
Similar safety and tolerability profile was observed in both arms
of the study. Additionally, diazepam nasal spray demonstrated
comparable plasma bioavailability to diazepam rectal gel.
Currently, Acorda is preparing to submit a 505(b)(2) type new
drug application (NDA) for diazepam nasal spray. The company
plans to submit the regulatory application to the US Food and
Drug Administration (FDA) in 2013.
We note diazepam nasal spray was added to Acorda's neurology
pipeline following the acquisition of privately-held Neuronex,
Inc. in Dec 2012.
We are pleased with the company's efforts to develop its
pipeline. However, most of the candidates are in early stages of
development. Consequently they are quite a few years away from
entering the market, if at all. We are also concerned about
Acorda's dependence on Ampyra (improve walking in patients with
multiple sclerosis), which accounts for the bulk of the company's
net product revenues, for growth.
While we are encouraged by the improvement in Ampyra's
performance in the fourth quarter of 2012 and the 2013 Ampyra
guidance, it remains to be seen whether the trend can be
Acorda carries a Zacks Rank #4 (Sell) in the short run. Stocks
that currently look attractive in the pharma space include
Osiris Therapeutics, Inc.
) . While Cytokinetics and Osiris are Zacks Rank #1 (Strong Buy)
stocks, Agenus is a Zacks Rank #2 (Buy) stock.