PDUFA date of APF530 expected next week (Nasdaq:APPA)

APF530 is a drug that has been developed by A.P. Pharma Inc. (Nasdaq:APPA) using its “Biochronomer™ polymer-based drug delivery technology”. By far, it is the most important pharmaceutical product developed by this medium-sized specialty pharmaceutical company. Last year, the company finished the Phase 3 trial that measured the safety and the effectiveness of the drug in preventing chemotherapy-induced nausea and vomiting (CINV). Afterwards, on May 18, 2009, the company submitted a new drug application (NDA) to the United States of America’s Food and Drug Administration in order to get the regulator’s approval for bringing the APF530 into the market. On July 30, 2009, A.P. Pharma disclosed to its stakeholders that the FDA has found the NDA to contain all the information that would allow a thorough review of APF30 – that is, the NDA was accepted for review. The regulator has also given the company a Prescription Drug User Fee Act goal date – also called Action date or just PDUFA date. This is the day by which the Food and Drug Administration must complete its review and announce whether it has accepted the NDA of APF530 or not. At present, the PDUFA date is March 18, 2010.

APF530 is made of granisetron, which is a 5-HT3 antagonist. The current FDA regulations allow granisetron oral tablets and injections to be used only in cases of acute onset CINV. However, according to the company, the Phase 3 trial results showed that APF530 could be used for acute onset CINV as well as for delayed onset CINV. The trial was conducted in several centers. A total of 1,395 people suffering from cancer took part in this trial.

Most cancer patients suffer from nausea and vomiting after being exposed to chemotherapy – which is a necessary form of cancer treatment. Acute onset CINV starts the day the patient gets chemotherapy treatment while delayed onset CINV starts much later than that. If the NDA for APF530 gets approved by the FDA, it will be the only drug – other than Palonesetron injections – to be used for delayed onset CINV.

After the news of the FDA’s acceptance for review of the NDA was released, Ronald J. Prentki, who is the CEO and also the President of A.P. Pharma, said:

“The acceptance of the APF530 NDA represents another important step towards providing physicians and patients with a potential new long-acting therapeutic agent to combat chemotherapy-induced nausea and vomiting. Our team recognizes the important role APF530 could play in cancer care, and we are dedicated to working with the FDA as it reviews our NDA submission.”