FDA Actions
April 1, 2014
The FDA has approved droxidopa for the treatment of neurogenic orthostatic hypotension in patients with Parkinson’s disease, multiple-system atrophy, and pure autonomic failure. The drug was approved under the accelerated approval program, which allows approval for a serious disease if the drug has an effect on intermediate clinical measures. The approval was based on very short-term clinical trials (2 weeks) where subjects reported a decrease in dizziness, lightheadedness, feeling faint, or feeling as if he/she might black out compared to placebo. Durability of symptom improvement beyond 2 weeks has not been demonstrated. Droxidopa is marketed by Chelsea Therapeutics as Northera.
Last year, a meta-analysis of various non-steroidal anti-inflammatory drugs (NSAIDs) showed an increased cardiovascular risk, with high-dose diclofenac and celecoxib conferring the highest risk while ibuprofen was associated with a lower risk. Naproxen was not associated with cardiovascular risk (Lancet 2013;382:769-779, doi: 10.1016/s0140-6736(13)60900-9). Now, an FDA advisory panel is suggesting that there are not enough data to allow the makers of naproxen (Naprosyn, Aleve, etc.) to change their labeling based on those data. The advisors are waiting for the results of the PRECISION trial, started in 2006, which is evaluating the safety of celecoxib vs naproxen or ibuprofen in patients at high risk for cardiovascular disease.
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