Novel GI Safer Aspirin Significantly Reduces Ulcers Compared to Regular Aspirin
GI Safer Formulation Shows Promise in Addressing Key Aspirin Safety Concerns
Houston, TX, April 28, 2010 – PLx Pharma, a pharmaceutical company developing safer formulations of proven non-steroidal anti-inflammatory drugs (NSAIDs), today announced positive results from the company’s Phase 2 endoscopic study of PL 2200 Aspirin, a novel immediate-release investigational product containing 325 mg aspirin. Findings demonstrated a 71.0% reduction in the incidence of gastric and duodenal ulcers (p=0.0069) and a 47.4% lower incidence of combined erosions and ulcers (p=0.0025) for a once-a-day dose of PL 2200 Aspirin as compared to immediate-release over-the-counter aspirin, following administration for 7 days.
“We are very pleased that these study findings support our belief that PL 2200 may offer a significantly GI safer aspirin product to the tens of millions Americans who rely on aspirin for its various health benefits and the many more that need these product attributes,” stated Ron Zimmerman, president and chief executive officer of PLx Pharma.
“With widespread use of aspirin for the treatment and prevention of cardiovascular disease, as well as for pain and fever, there is a need for an aspirin product that has improved gastrointestinal safety without reducing its effectiveness. The use of aspirin alone or in combination with other drugs markedly increases the risk of peptic ulcer disease,” said Byron Cryer, M.D., with the University of Texas Southwestern Medical School and VA North Texas Health Care System, a lead investigator for this trial. “This trial in 201 healthy adults between the ages of 50 and 75 years, who are at risk for cardiovascular disease and stomach injury, demonstrated that aspirin, even with short-term exposure, induced a surprisingly high incidence of ulceration and this damage could be significantly decreased with PL2200 Aspirin.”
Deepak Bhatt, M.D., M.P.H., with the VA Boston Healthcare System and Brigham and Women's Hospital, said, “Aspirin is frequently used in combination with other anti-platelet agents, which increases the risk of bleeding. We frequently use proton pump inhibitors to mitigate the risk of life threatening gastrointestinal bleeding. In the future, physicians may be able to use additional and complementary approaches to improve the gastrointestinal safety of aspirin, potentially with PL2200 Aspirin.”
In a previous trial, PL 2200 Aspirin demonstrated equivalent anti-platelet activity with 325 mg immediate-release aspirin. PL 2200 Aspirin is being developed as a safer and cost effective over-the-counter alternative for those patients most at risk for aspirin-induced gastrointestinal problems, including those taking aspirin daily for cardiovascular disease prevention, for use with a prescription anti-platelet agent, and for arthritic patients taking high-dose NSAIDs chronically.
About PLx Pharma
PLx Pharma is a privately-owned pharmaceutical company developing proprietary formulations of proven nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, naproxen and ibuprofen which possess significantly improved gastrointestinal (GI) safety profiles. Based on PLx’s unique phospholipid based drug delivery technology, these products are designed to overcome the significant and sometime life threatening GI toxicity associated with NSAIDs while offering the same proven therapeutic benefits.
Statements included in this press release may contain forward-looking comments and are subject to risks and uncertainties. Actual results may differ from those indicated. The forward-looking statements contained in this press release are made as of the date hereof, and PLx Pharma does not undertake any obligation to update any forward-looking statements, whether as a result of future events, new information or otherwise.
Posted: May 2010