(RxWiki News) Aspirin is frequently called a "wonder pill," but many long-term users end up with painful stomach ulcers. So what if a pill could deliver the benefits of aspirin without the side effects?
A new drug has had successful results in two Phase 3 clinical trials in reducing stomach ulcers for long-term aspirin users.
The results were announced this week by Pozen, the maker of the new drug.
"Relief may be in sight for aspirin users at risk for stomach ulcers."
Stomach ulcers are common for daily aspirin users, who may be taking the pill to reduce their risk of heart attack. But stomach ulcers can cause indigestion and heartburn.
The new drug would dial down these side effects while still providing the daily dose of aspirin, in one pill.
Pozen's drug is a combination of two medicines. The first is omeprazole, a drug that's used to treat gastroesophageal reflux disease (GERD) and ulcers.
The brand name for omeprazole is Prilosec. It's in a class of drugs called proton-pump inhibitors, common among heartburn sufferers.
The second drug is delayed release aspirin. The combination treatment is being called PA32540 while it's still in clinical trials.
Phase 3 is the final testing phase of clinical trials before it can be considered by the FDA. The pharmaceutical company plans to apply for FDA approval in the third quarter of 2012.
If approved, the drug would offer an alternative to taking aspirin and Pilosec separately.
The trials involved over 1,000 patients who had been taking 325 mg of aspirin every day, for at least three months, in order to prevent heart attack. These patients were considered at risk for developing stomach ulcers from their aspirin use.
The patients were divided into two groups: One took the new drug, and the other continued taking their regular dose of aspirin.
After six months, the patients taking the new drug had fewer stomach ulcers than the patients taking aspirin alone.
The patients on the new drug were also less likely to discontinue use of the drug due to GERD symptoms like heartburn, compared to those taking aspirin.
In a statement, John R. Plachetka, Pozen's CEO, said he was optimistic about the drug's future.