A.P. Pharma Announces PDUFA Action Date for APF530 New Drug Application Resubmission
10/16/2012
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"The acceptance of our New Drug Application for APF530 represents an
important step towards providing physicians and patients with a
potential new long-acting therapeutic agent to combat the debilitating
side effects of nausea and vomiting associated with many chemotherapy
treatments," said
A.P. Pharma’s NDA for APF530, which was resubmitted to the
About CINV
Prevention and control of nausea and vomiting, or emesis, are very important in the treatment of cancer patients. The majority of patients receiving chemotherapy will experience some degree of emesis if not prevented with an antiemetic, typically administered just prior to chemotherapy.
Chemotherapy treatments can be classified as moderately emetogenic, meaning that 30% to 90% of patients experience CINV, or highly emetogenic, meaning that more than 90% of patients experience CINV, if they do not receive an antiemetic. Acute-onset CINV occurs within the first 24 hours following chemotherapy treatment. Delayed-onset CINV occurs more than 24 hours after treatment and may persist for several days. Prevention of CINV is important because the distress caused by CINV can severely disrupt patient quality of life and can lead some patients to delay or discontinue chemotherapy.
About APF530
About
Forward-looking Statements
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995. These
forward-looking statements involve risks and uncertainties, including
uncertainties associated with the potential approval of APF530 and the
potential timing for such approval, if approved at all, as well as risks
relating to capital resources and liquidity, satisfactory completion of
clinical studies, progress in research and development programs, launch
and acceptance of new products and other risks and uncertainties
identified in the Company's filings with the
Source:
Investor Relations Contact:
Michael Rice
Office Phone:
(646) 597-6979
Email: mrice@lifesciadvisors.com
and
Corporate
Contact:
John B. Whelan, President and Chief Executive Officer
Office
Phone: 650-366-2626