Breaking News From Pharma & Bio Ingredients Subscribe via RSS Subscribe via RSS



NovaDel Has Positive Migraine Spray Data


Posted on 2006-09-28 17:17:00



Specialty drugmaker NovaDel Pharma Inc. said Thursday it plans to finish assembling data to support a Food and Drug Administration application in 2007 for its migraine treatment, after it reported positive results from a clinical trial.

NovaDel said a pilot study showed that its oral spray sumatriptan was absorbed by the body significantly quicker than Imitrex, a migraine treatment in tablet form from U.K. drugmaker GlaxoSmithKline PLC.

In the study, at least 90 percent of participants had detectable drug levels of sumatriptan three minutes after dosing, compared to 10 percent of patients taking a 50 milligram tablet of Imitrex. At three to six minutes, the spray had significantly higher average concentrations compared with the tablet.

The company said the rate the drug is absorbed is one of the most important predictors of migraine relief.

NovaDel plans to apply for marketing approval using the FDA's 505(b)(2) regulatory pathway, in which the agency can approve an application that makes use of data not developed by the applicant.

The company said about 26 million people in the U.S. suffer from migraine headaches, which cost employers about $13 billion a year in lost work time.


NEWS ARCHIVES

2008

2007

2006

2005

2004

NEWSLETTER SIGNUP