FDA approves first liquid-filled aspirin capsule

PLx Pharma has won FDA approval for its liquid-filled aspirin capsule Vazalore. The formulation has bettered enteric-coated and immediate-release aspirin in some regards in clinical trials.

Aspirin is sold in enteric-coated and immediate-release forms. Enteric coating is designed to ensure the dosage form only fully dissolves upon reaching the small intestine, potentially reducing stomach irritation. However, there is also some evidence that the coating reduces absorption in some people, making the plain, immediate-release formulation a better option in certain situations. 

Now, PLx has provided patients with a third aspirin option. Vazalore, which comes in full-strength and low-dose versions, is a capsule that contains aspirin in a liquid form. The product is based on the PLxGuard drug delivery platform, which is designed to enable the release of the active ingredient to targeted portions of the gastrointestinal tract.

In the context of aspirin, targeted release could prevent the ulceration and other issues that arise in people who take daily low doses of the drug. A 2011 study linked Vazalore to a lower rate of ulcers and erosions than plain aspirin.

The 2011 study lacked a comparison to enteric-coated aspirin. Other studies compared the plasma concentrations and time to complete anti-platelet effects of all three types of aspirin. Vazalore acted faster than enteric-coated aspirin. PLx showed bioequivalence to the faster-acting immediate-release aspirin.

Armed with the data, PLx will now try to make the case for using Vazalore instead of well-established immediate-release and enteric-coated formulations of aspirin. The pitch rests on the potential to reduce the risk of stomach injury in the millions of people who use aspirin as an anti-platelet therapy. PLx plans to launch the product later this year.