A.P. Pharma Revises Target Date for APF530 NDA
12/18/2008
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REDWOOD CITY, Calif.--(BUSINESS WIRE)--
Together with its regulatory consultants, the company recently completed
a comprehensive review of the APF530 NDA, which is currently under
development. Among the results from this assessment was a recommendation
that the company conduct and include in the NDA additional sterility
testing and analyses of the transfer and delivery system used in
administering the product to patients. The company accepted this
recommendation. The additional testing is being completed with the
objective of submitting a comprehensive sterility assurance package to
FDA and does not reflect any particular issues with either the transfer
system or any specific concerns regarding the sterility of the product.
The company has determined that with the incorporation of this
additional work, the target NDA filing date would need to be adjusted
from late
The company does not expect this delay to significantly impact the timeline for approval, which is still projected for the first quarter of 2010.
Commenting on the NDA submission, Ronald Prentki,
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 anti-emetic, 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 anti-emetic. 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 significant 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 and the Phase 3 Trial
The pivotal Phase 3 clinical trial, initiated in
About
Forward-looking Statements
This news release contains "forward-looking statements" as defined by
the Private Securities Reform Act of 1995. These forward-looking
statements involve risks and uncertainties, including uncertainties
associated with timely development, approval, launch and acceptance of
new products, establishment of new corporate alliances, and other risks
and uncertainties identified in the Company's filings with the
CONTACT: Investor Relations Contacts:
dmarkley@lhai.com
or
Company Contacts:
Ronald Prentki, President and Chief Executive Officer
650-366-2626
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