Application was submitted for both the 81 and 325 mg doses of the liquid-filled capsule formulation of aspirin.
FDA approved the supplemental new drug applications (sNDAs) for PLx Pharma’s Vazalore, the first liquid-filled aspirin capsule.
Vazalore is approved by FDA to provide patients with vascular disease or diabetes who are candidates for aspirin therapy with “fast, reliable and predictable platelet inhibition as compared to enteric-coated aspirin,” PLx Pharma said in a press release. “It also reduces the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting.”
A promotional video on the company website says the liquid-filled capsules are designed to protect the stomach by releasing the aspirin in the duodenum.
Last October, the company submitted separate sNDAs for each dose strength, based on a change in formulation and the new manufacturing site for Vazalore 325 mg along with a new product strength for the 81 mg dose.
PLx Pharma’s sNDA for the 325 mg dose includes the results of a clinical study that demonstrated Vazalore’s bioequivalence to immediate-release aspirin, “further supporting the change in formulation,” the drugmaker said in the press release.
“We are delighted that the FDA approved both sNDAs for Vazalore and we are eager to implement our commercial launch plans later this year,” said Natasha Giordano, president and CEO of PLx. “We look forward to introducing Vazalore to the medical community and to patients who can benefit from this breakthrough technology designed to reduce the risk of stomach injury."