Boston, MA 02/12/2014 (wallstreetpr) – Bayer AG (ADR) (OTCMKTS:BAYRY) has suffered a blow of FDA advisory panel rejection of its pain medicine naproxen which sells as Aleve. The panel’s decision means that changing label of the drug might not be possible with the currently available clinical trial data.
The panel decided in 16-9 vote against naproxen, saying that the available trail data do not support observations that the medicine poses lower risk of cardiovascular event than the other available, or better yet, common medications like ibuprofen, Advil and Celebrex.
A nod to the proposal put across for naproxen would have allowed a review of the drug’s label to reflect that it is better than the common painkillers which bear label heart warning. However, although medical research claim that naproxen is better than its peers and that it carries lower if not the lowest risk to hear compared to peers, FDA advisory committee failed to see that support in the data available on the drug.
Bayer AG (ADR) (OTCMKTS:BAYRY) sells naproxen as Aleve and had sought a label review which from a business point of view would put the drug in a competitive edge. Millions of Americans spend millions or even billions of dollars every year on drugs that offer relief for aches and pains in the body. However, medical studies have found that such drugs have a link to cardiac events, meaning that they can cause or accelerate heart conditions.
A case for naproxen
Among the available painkillers, naproxen has been put to many tests and trials by researchers and many, if not all, have returned results that it is far less risky to use. Even the panel that rejected request to change label on the drug cites that scientific rational show that naproxen is safer than common painkillers. Yet, the issue is that the available data is insufficient to make a definitive statement, that is, support change of label of the drug. On that account, the FDA advisory committee said NO.
What next for Bayer
FDA will take a look at the opinion of its advisory panel. The FDA is never bound to follow the recommendation of its advisory committee. That means that it won’t be surprising if a different thing emerges from the FDA desk regarding naproxen. Nonetheless, it is important to remember that FDA often follows on the recommendation of the advisory committee. That means that things may not be really good for Bayer AG (ADR) (OTCMKTS:BAYRY) up there.
