Low-dose aspirin or baby aspirin has been widely prescribed as a prevention measure against heart attacks and strokes. But about 15 percent of patients prescribed this treatment cannot take it because of gastrointestinal side effects like ulcers. Pozen’s (NASDAQ: POZN) aspirin alternative has produced positive Phase 3 results and were presented at the American Heart Association’s Scientific Sessions in Los Angeles.
Pozen’s drug, developed by the company, combines a 40mg dose of omeprazole, a proton pump inhibitor, surrounded by pH-sensitive aspirin in 325 mg and 81 mg dosages.
Two Phase 3 clinical trials enrolled 1,049 subjects in double blind studies over 24 months comparing enteric-coated aspirin with Pozen’s aspirin alternative, PA32540. The primary endpoint of the study was how many incidents of gastric ulcers there were over a six month period, according to a company statement. Secondary endpoints measured incidents of gastric and duodenal ulcers, people who stopped taking the medication due to problems with their upper GI tract and heartburn. It found that participants on PA32540 were able to stay on medication longer because they suffered fewer GI tract conditions like gastritis and dyspepsia. Although 71 percent of people prescribed Pozen’s remedy still suffered adverse events, a greater number of people on enteric-coated aspirin — 85 percent — suffered adverse effects.
About 24 million people are prescribed aspirin as a secondary prevention measure, according to data from the company. Pozen’s drug would be aimed at the 15 percent of people on low-dose aspirin identified as at risk for upper GI adverse events. About 12 percent of those prescribed aspirin discontinue or reduce the amount they’re supposed to take due to serious upper GI tract side effects, according to the company. With the healthcare and pharmaceutical industries trying to improve patient adherence, the drug represents one way to offer a preventive measure against cardiovascular disease for people who might be physically unable to take low dose aspirin.
Chapel Hill, North Carolina-based Pozen is currently looking for a strategic partner for the drug. The company envisions its aspirin alternative as an accessible, affordable treatment.
“We are not envisioning a big price tag for this drug,” said Liz Cermak, Pozen’s chief commercial officer in a phone interview.
The company expects to submit the drug for approval in the US in the first of 2013 and apply for approval in Europe in the second half of that year.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
