aaiPharma Inc has received confirmation of U.S. Food and Drug Administration (FDA) approval of Darvocet A500 (propoxyphene napsylate and acetaminophen) for the treatment of mild to moderate pain. Darvocet A500 is the only propoxyphene napsylate/acetaminophen combination product currently FDA approved that contains a lower (500 mg) dose of acetaminophen combined with 100 mg of propoxyphene napsylate, the same dose of propoxyphene napsylate found in Darvocet-N 100. This new product will provide patients a unique Darvocet formulation with the safety benefits of less acetaminophen and the full power of propoxyphene.
"Darvocet A500 will provide an important alternative for health care providers concerned about high acetaminophen intake in patients suffering from mild-to-moderate pain," commented Dr. Philip S. Tabbiner, President and CEO of aaiPharma. "Because the FDA has established a 4,000 mg maximum daily dose of acetaminophen for adults and physicians are concerned about patients who self medicate using over-the-counter products, we believe there is a significant market opportunity for this dose combination which contains less acetaminophen while retaining the full power of propoxyphene napsylate. This product is a clear illustration of our strategy to bring to market line extensions that make established products safer for patients and patient management easier for physicians."
As previously announced, aaiPharma acquired the product from Athlon Pharmaceuticals. The Company is preparing for an immediate launch to the trade followed by a national launch of Darvocet A500 in October.
Darvocet A500 contains 100 mg of propoxyphene napsylate and 500 mg of acetaminophen compared to the Darvocet-N 100 presentation, which contains 100 mg of propoxyphene and 650 mg of acetaminophen. The Darvocet-N 100 presentation, branded and generic, currently accounts for 95% of the more than $500 million total propoxyphene market, according to Verispan data.