The safer aspirin that Pozen (NASDAQ:POZN) developed for cardiovascular applications has been submitted for regulatory approval.
Chapel Hill-based Pozen said the new drug application for its PA drug candidates covers two dosages, 325 mg and 81 mg. The drug filing with the Food and Drug Administration comes a little sooner than expected. Pozen had said earlier this month that it expected to make a filing in the second quarter.
The 325 mg pill, PA 32540, and the 81 mg pill, PA32540, were developed to deliver aspirin in a manner that avoids the risk of stomach irritation common with aspirin alone. Pozen is offering a delayed release aspirin combined immediately released omeprazole, which reduces stomach acid. The combination drug is intended to offer the cardiovascular benefits of aspirin in a way that reduces the ulcer-risks that makes aspirin intolerable for some patients. The company has also said it plans to pursue other indications for its PA platform, including cancer.
Pozen pledges to sell its PA drugs at $1 a day, a price that company research showed would be acceptable to patients and payers. The company plans to commercialize the PA drugs with a partner. Pozen offered no new developments on that front but CEO John Plachetka suggested a deal could be coming soon.
“We look forward to completing a commercial deal in the upcoming months with a partner that shares our passion for this product, our values, and is capable of making PA reach its fullest potential in the marketplace,” Plachetka said in a statement.
If approved, a safer-on-the-stomach aspirin would become Pozen’s third commercialized product. The company has commercialized migraine treatment Treximet with partner GlaxoSmithKline and arthritis drug Vimovo with partner AstraZeneca.
