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Acorda Shelves Development of Epilepsy Treatment, Plumiaz
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Acorda Therapeutics, Inc. is terminating the development of Plumiaz (diazepam) Nasal Spray, its experimental therapy for the treatment of seizure clusters in people with epilepsy. The company said that data from ongoing studies showed that Plumiaz did not demonstrate its bioequivalence to Diastat rectal gel.
In fact, results showed unexpectedly lower nasal mucosa absorption of diazepam in persons with epilepsy compared to studies in healthy volunteers.
Acorda needed to show bioequivalence in order to re-file a New Drug Application (NDA) under section 505(b)(2). As a reminder, Acorda had received a complete response letter (CRL) from the FDA in May 2014 for Plumiaz. A year later, the company had said that it would be conducting three studies on Plumiaz based on discussions with the FDA.
Positive data from these studies would have allowed Acorda to re-submit its regulatory application in the first quarter of 2017. Plumiaz became a part of Acorda’s pipeline following its Dec 2012 acquisition of Neuronex and Acorda was forecasting Plumiaz U.S. annual peak sales of more than $200 million.
With Plumiaz being one of the most advanced candidates in Acorda’s pipeline, the news comes as a disappointment.
Meanwhile, Acorda will be focusing on the development of its other pipeline candidates including CVT-301 (phase III program ongoing for the treatment of OFF episodes in Parkinson’s disease patients), Ampyra (dalfampridine - post-stroke walking difficulty), and tozadenant (in phase III development for the reduction of OFF time in Parkinson’s disease patients).
While a NDA filing for CVT-301 is expected in 2017, Acorda plans to file for FDA approval of tozadenant by the end of 2018.
Acorda is a Zacks Rank #2 (Buy) stock. Some better-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. (ANIP - Free Report) , Heska Corporation and Retrophin, Inc. . All three are Zacks Rank #1 (Strong Buy) stocks.
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Acorda Shelves Development of Epilepsy Treatment, Plumiaz
Acorda Therapeutics, Inc. is terminating the development of Plumiaz (diazepam) Nasal Spray, its experimental therapy for the treatment of seizure clusters in people with epilepsy. The company said that data from ongoing studies showed that Plumiaz did not demonstrate its bioequivalence to Diastat rectal gel.
In fact, results showed unexpectedly lower nasal mucosa absorption of diazepam in persons with epilepsy compared to studies in healthy volunteers.
Acorda needed to show bioequivalence in order to re-file a New Drug Application (NDA) under section 505(b)(2). As a reminder, Acorda had received a complete response letter (CRL) from the FDA in May 2014 for Plumiaz. A year later, the company had said that it would be conducting three studies on Plumiaz based on discussions with the FDA.
Positive data from these studies would have allowed Acorda to re-submit its regulatory application in the first quarter of 2017. Plumiaz became a part of Acorda’s pipeline following its Dec 2012 acquisition of Neuronex and Acorda was forecasting Plumiaz U.S. annual peak sales of more than $200 million.
With Plumiaz being one of the most advanced candidates in Acorda’s pipeline, the news comes as a disappointment.
Meanwhile, Acorda will be focusing on the development of its other pipeline candidates including CVT-301 (phase III program ongoing for the treatment of OFF episodes in Parkinson’s disease patients), Ampyra (dalfampridine - post-stroke walking difficulty), and tozadenant (in phase III development for the reduction of OFF time in Parkinson’s disease patients).
While a NDA filing for CVT-301 is expected in 2017, Acorda plans to file for FDA approval of tozadenant by the end of 2018.
Acorda is a Zacks Rank #2 (Buy) stock. Some better-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. (ANIP - Free Report) , Heska Corporation and Retrophin, Inc. . All three are Zacks Rank #1 (Strong Buy) stocks.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>