Avanir Pharmaceuticals Inc. announced that the Food and Drug Administration will allow it to speed research on a newer version of its drug Nuedexta.
Avanir said the FDA agreed to a faster development process for its experimental drug AVP-786 and will allow the company to use some data from studies of Nuedexta in its applications for AVP-786.
Avanir plans to start human clinical trials of the drug after it completes some limited preclinical testing. The company said the FDA’s decision could reduce the cost of developing the drug and allow it to win marketing approval sooner.
Nuedexta is a treatment for pseudobulbar affect, a condition that involves involuntary emotional outbursts like laughing or crying. It is associated with brain disease or injury. Net revenue from the drug more than doubled to $31.4 million over the first six months of the company’s current fiscal year. That was almost all of the Aliso Viejo, Calif., company’s revenue.
Nuedexta was approved in February 2011. The drug combines two ingredients: dextromethorphan, a common ingredient in cough and cold medicines that can suppress coughing, and quinidine, which is used to treat abnormal heart rhythms.
Avanir is also studying Nuedexta as a treatment for diabetic nerve pain, agitation in patients with Alzheimer’s disease, central nerve pain in multiple sclerosis, and levodopa-induced dyskinesia in Parkinson’s disease. Dyskinesias are involuntary movements tied to most treatments used to manage Parkinson’s.
Canaccord Genuity analyst Ritu Baral said Avanir considers AVP-786 to be a safer version of Nuedexta because it contains less quinidine. The drug also has stronger patent protection and is patent protected until 2030, a few years longer than Nuedexta.
In a telephone interview, Baral said the FDA’s decision could speed approval of AVP-786 by two to four years. She said Avanir may start late-stage testing of the drug in the second half of 2014 depending on the results of current studies of Nuedexta.