A cancer diagnosis is devastating, and oftentimes the treatment following such diagnosis can be just as mentally and physically debilitating. The majority of patients receiving treatment experience some degree of emesis, or nausea and vomiting, associated with chemotherapy. The prevention and control of emesis is very important for the patient, and chemotherapy patients are typically administered an anti-emetic prior to treatment.
Specialty pharmaceutical company A.P. Pharma Inc. (Nasdaq: APPA) today announced positive results from its pivotal phase III study that compares the efficacy of the company’s lead product, APF530, with Aloxi for the prevention of emesis, also known as chemotherapy-induced nausea and vomiting (CINV).
The phase III trial is based on the participation of 1,395 patients, treated at 103 centers in the United States, Poland and India. The patients were classified according to their level of emetogenic chemotherapy to demonstrate the safety and efficacy of APF530.
According to the press release, A.P. Pharma’s APF530 was “generally well tolerated.” Regarding a side effect correlated with previous human use of granisetron (which is used in APF530), only one serious adverse event was reported as possibly attributed to APF530.
“We are highly encouraged with the results of our phase III trial and are working diligently to get our product approved for marketing as soon as possible. In the meantime, we will be carefully evaluating the best way to maximize the value of this asset for our shareholders,” Ronald Prentki, A.P. Pharma’s president and CEO stated in the press release.
From here, the company intends to create a data package appropriate for inclusion in its New Drug Application (NDA), which it plans on submitting to the U.S. Food and Drug Administration (FDA) during the fourth quarter of 2008.
“According to our market research, there are more than 6 million cycles of chemotherapy administered each year in the U.S. We believe this equates to an annual market opportunity in excess of $1 billion. Importantly, virtually all patients who experience acute onset nausea and vomiting will also experience delayed onset nausea and vomiting,” Prentki stated.
“There is currently only one 5HT3 antagonist, Aloxi, that addresses both acute and delayed segments. We are delighted to have the second product to potentially address this use. We believe that the positive results announced today from one of the largest randomized clinical trials ever conducted in CINV, together with physicians’ historical positive experience with our active ingredient, granisetron, will allow APF530 to play a major role in serving cancer patients,” he continued.
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