Aralez Pharmaceuticals Inc. (Nasdaq: ARLZ) announced today that the U.S. Food Drug Administration (FDA) had approved once-daily Yosprala. This drug is the first aspirin to include omeprazole, an acid-fighting drug, to prevent gastric ulcers. Patients that have to take aspirins for life are vulnerable to suffer stomachal damages, but Yosprala protects the stomach to prevent those type of diseases.

People that had a heart attack have to take aspirins every day to avoid a secondary cardiovascular event. It is also and standard treatment for patients who have suffered a cerebrovascular event.  But aspirin, if taken for a long time, can cause gastrointestinal side effects, including stomach bleeding.

Yosprala helps with prevention of cardiovascular disease in patients at-risk for aspirin-induced ulcers. Image Credit: Benzinga

Fortunately, Yosprala, from the Canada-based Aralez, was designed to support both cardio- and gastroprotection for secondary prevention of cardiovascular and cerebrovascular incidents. The recently-approved drug has an Intelli-COAT system, which is programmed to sequentially release 40mg of omeprazole followed by a delayed-release of aspirin in either 81 mg or 325 mg doses.

The omeprazole elevates the gastric pH into a gastroprotective zone, and the aspirin later dissolves when the pH has been elevated to ≥ 5.5. This reduces stomach ulcer risk and allows people to buy one pill instead of the two drugs separated: the aspirin and the omeprazole.

Adrian Adams, Aralez’s CEO, explained that people could buy over-the-counter omeprazole and aspirin and take them together, but the effect would not be the same. For the omeprazole to be protective, it has to be taken half an hour to an hour before the aspirin, which is inconvenient and most patients forget to do it. But Yosprala solves this issue, and now those preventing a secondary heart attack can buy one pill and take care of their heart and stomach.

Adams said in an interview that patients would spend less than a dollar a day to buy the product because the company is very conscious of the controversy surrounding high pricing of older drugs.

The FDA approved Yosprala based on several clinical trials and its sell in the U.S. rose Arazel’s shares

The company’s shares increased from 55 cents to $6 on the Nasdaq Stock Exchange after the FDA approved the sale of the pill in the United States. Arazel said it is expanding its U.S. sales force from 85 to 110 this month and plans the first promotional launch of Yosprala in the first week in October.

The FDA based its approval on the results from two randomized, double-blind clinical trials. Patients were randomly assigned to receive either Yosprala 325 mg/40 mg or 325 mg of enteric-coated aspirin. Each study found that those participants using Yosprala experiences significanñy fewer endoscopic gastric ulcers compared to those who took enteric-coated aspirin.

Also, significantly fewer patients who took Yosprala discontinued therapy because of gastrointestinal side effects compared to patients who did not take the Canadian drug.

“Published research shows that patients who have or are at risk of coronary artery disease and discontinue daily aspirin treatment have a three-fold higher risk of a major adverse cardiac event, including death, shortly after stopping therapy,” explained Dr. Lori Mosca, M.D., M.P.H., Ph.D. a national expert in cardiovascular disease prevention and education.

Adams stated the approval of their pill marks a significant achievement for Aralez and helps address the current public health dilemma around patient discontinuation of daily aspirin therapy, which has potentially dangerous consequences.

Source: Montreal Gazette