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 option.
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 Europe.
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 growth.
At present, companies like Biogen Idec (BIIB - Analyst Report) , Aeterna Zentaris Inc. (AEZS - Snapshot Report) and Protalix BioTherapeutics, Inc. (PLX - Snapshot Report) look well-positioned. All three are Zacks Rank #1 (Strong Buy) stocks.