The U.S. Food and Drug Administration rejected Avanir Pharmaceuticals Inc's migraine drug device, a few weeks after the regulator had raised questions regarding some data submitted as part of the marketing application.
Earlier this month the FDA had asked Avanir to assess the root cause of errors observed in the data from the drugmaker's human factors study, which assesses if patients can use a device safely and effectively.
The product, AVP-825, delivers a low-dose sumatriptan powder - the most commonly prescribed migraine medicine - through the nose.
Avanir on Wednesday said it would conduct a new human factors study and respond to the FDA's complete response letter in the first half of next year.
The FDA was slated to decide on the product on November 26.
For more details, go to: http://www.reuters.com/article/2014/11/26/us-avanir-fda-migraine-idUSKCN0JA2BS20141126