Acorda Therapeutics, Inc.
) recently presented data on diazepam nasal spray from the first
study that was conducted to evaluate the candidate's
pharmacokinetics, safety and tolerability in people with
epilepsy. These results were presented at the biennial
International Congress of the International League Against
Epilepsy (ILAE) and International Bureau for Epilepsy (IBE).
Acorda said that diazepam nasal spray's pharmacokinetic
profile was similar irrespective of whether it was administered
during or immediately after a seizure. The company said that it
was well absorbed from the nasal cavity and well tolerated.
Common adverse events observed in the open-label, multi-center
study were mostly connected to the form of delivery and could be
resolved within a day.
Acorda is developing diazepam nasal spray for the treatment of
people with epilepsy who have cluster seizures (acute repetitive
seizures). The company also presented results from another study
which showed that diazepam nasal spray's bioavailability in
healthy volunteers was comparable to that of the rectal gel
formulation of diazepam. Diazepam nasal spray, once approved and
launched, will provide patients with a convenient treatment
Acorda is preparing to submit a 505(b)(2) type new drug
application for diazepam nasal spray later this year.
Diazepam nasal spray became a part of Acorda's pipeline
following its Dec 2012 acquisition of Neuronex, Inc. Acorda has
been working on strengthening its pipeline. Apart from the
Neuronex acquisition, the company announced a deal earlier this
year for the acquisition of rights to two assets in the US,
Canada, Latin America and certain other markets excluding
Acorda currently carries a Zacks Rank #3 (Hold). We are
encouraged by the company's efforts to strengthen its pipeline
and reduce its dependence on a single product, Ampyra, for
At present, companies like
Aeterna Zentaris Inc.
Protalix BioTherapeutics, Inc.
) look well-positioned. All three are Zacks Rank #1 (Strong Buy)
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