Avanir Pharmaceuticals Inc said its drug was more effective in reducing agitation associated with Alzheimer’s, compared with a placebo, sending the company’s shares up 55 percent to an over eight-year high.
The company said based on the mid-stage trial data it planned to request a meeting with both the U.S. Food and Drug Administration and the European Medicines Agency.
Alzheimer’s is the most common form of dementia and is a progressive neurodegenerative disease, which eventually leads to death.
There are no FDA-approved therapies to treat Alzheimer’s-related agitation, Avanir said on Monday.
The drug, AVP-923, is already approved for treatment of pseudobulbar affect since October 2010 under the trade name Nuedexta.
The drug is also being tested for a range of disorders including Parkinson’s disease, depression, autism and Bulbar function.[eap_ad_2]
The most common adverse reactions observed in the trial were falls, diarrhea and urinary tract infection, which occurred in less than 10 percent of patients, the company said.
AVP-923 is a combination of two well-known drugs, dextromethorphan hydrobromide, a common ingredient used in cough suppressants, and low-dose quinidine sulfate used to treat irregular heartbeat.
An estimated six million Americans have Alzheimer’s, a number that has doubled since 1980 and is expected to be as high as 16 million by 2050, the company said.
The Aliso Viejo, California-based company’s shares were up at $10.49 on the Nasdaq, making them the biggest percentage gainer on the exchange. (Reuters)[eap_ad_3]