from the U.S. Food and Drug Administration ("FDA") pertaining to
its New Drug Application ("NDA") for CIP-ISOTRETINOIN. The FDA
indicated that the Company's application is approvable subject to
the resolution of two remaining issues. In addition to one
question related to chemistry, manufacturing and controls, the FDA
has requested that the Company provide additional safety data. The
Company believes that the clinical question raised has been
adequately addressed in the NDA submission and has appealed the
position taken by the FDA in its approvable letter using the
formal dispute resolution process. The appeal is ongoing.
On May 3, 2007, the Company received an approvable letter from the
FDA pertaining to its NDA for CIP-TRAMADOL. The FDA indicated that
the Company's application is approvable subject to the resolution
of certain issues, including a request for an additional adequate
clinical trial to provide further efficacy data.
In subsequent discussions with the FDA, the Company has obtained
clarification on the question of efficacy. The FDA has indicated
that the statistical methods used to analyze data from the
Company's clinical trials did not adequately address missing data
relating to subjects who dropped out of the trials. The Company
believes its submission includes sufficient efficacy data to
support regulatory approval.
The Company has a meeting scheduled with the FDA in November 2007
to obtain further clarification on the issues raised in the action
letter. The outcome of these discussions will help the Company
determine the most appropriate path forward to achieve final
|SOURCE Cipher Pharmaceuticals Inc.|
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