Online Pharmacy Medicine Blog

Today AstraZeneca encountered a major setback in trying to extend the patent life of it blockbuster acid reflux drug Nexium. The patent was denied a patent extension by US regulators who did not see what the wanted when Astra tried to combine the drug with aspirin.

Loss of patent for Nexium and its 5 billion in yearly sales would be a big problem for AstraZeneca, who is trying to develop new drugs to fill the shoes of those who have lost patent protection in key markets.

According to ABC news,

The Anglo-Swedish drugmaker said it got a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its application to market Axanum, which combines aspirin with esomeprazole, the active ingredient in Nexium.

The delay for Axanum follows success with another Nexium line extension product, Vimovo, which won a green light from the FDA at the end of April. Vimovo, developed with Pozen, combines the anti-inflammatory drug naproxen and esomeprazole.

AstraZeneca faces another regulatory hurdle on Wednesday when an FDA expert panel meets to consider whether to approve its new infant lung drug motavizumab.

Winning over the panel may be tough, after FDA staff reported in briefing documents released last week that the drug carried a higher risk of causing severe allergic reactions than the company’s older product Synagis.

The loss of Nexium’s patent would definitely lower prices, as generic competition would not be far behind. One way or another, there is no reason sweat it’s approval, buy your drugs here at ePharmacies.com to save now!

Heartburn drugs called proton pump inhibitors (PPIs) — such as Nexium, Prevacid, Protonix and Aciphex — were prescribed 80 million times in 2008. And millions more Americans used over-the-counter Prilosec to treat their acid reflux.

Why are these acid suppressants so popular?

Obviously, the biggest reason is that Americans eat a lot of junk. But another suspected reason, which you’re probably not aware of, is that these drugs are actually addictive.

No, they don’t cause you to get “high” — but they do leave you with serious withdrawal symptoms when you don’t take them.

As The People’s Pharmacy reports:

[Danish] researchers randomly assigned 120 healthy volunteers to receive either a PPI (Nexium) or a look-alike placebo. After eight weeks on the acid-suppressing drug, a placebo was substituted without the subjects’ knowledge. Heartburn symptoms were evaluated in both groups.

The people who had taken Nexium for two months suffered significant heartburn, indigestion and acid regurgitation after they were switched to placebo. The investigators concluded: “PPI therapy for 8 weeks induces acid-related symptoms in healthy volunteers after withdrawal.”

This doesn’t come as a complete surprise to readers of The People’s Pharmacy. Many have shared stories like this: “I started taking Prilosec in the ’90s. I now take Prevacid every day. Without it, I had heartburn so bad I thought I was having a heart attack.”

Another reader reported: “I’ve had exactly the same problem with Protonix and Nexium. I’ve tried to go off Protonix three times, but I suffer terrible burning in my stomach. My doctor just says, ‘Maybe you need it.’ But I know there are side effects, and I’d like to find another way to take care of my stomach problems.”

An editorial comment on the Danish study suggests that the indiscriminate use of PPI medications could aggravate the very symptoms that these drugs are supposed to treat and lead to an increased requirement for long-term therapy.

This is a great argument for attempting to treat the root cause of your heartburn, rather than immediately resorting to a PPI. Eating less is a good start. Avoiding fatty, acidic and spicy foods is also good, as is quitting smoking. And elevating your head when sleeping is an effective preventative.

That’s not to say that some people don’t need to take medications for their heartburn. There are all kinds of reasons why individuals, including otherwise fit and healthy ones, can come down with acid reflux.

If you are prescribed a PPI, be sure to talk with your doctor about timeframes and a game plan for discontinuing the drug. Research indicates that long-term use of PPIs can lead to pneumonia, weakened bones and other ailments.