ViroPharma Comments on Vancocin
EXTON, Pa., March 17, 2006 /PRNewswire-FirstCall via COMTEX/ -- ViroPharma
Incorporated (Nasdaq: VPHM) today made the following statements about
Vancocin(R):
We were informed yesterday that the Office of Generic Drugs, Center for Drug
Evaluation and Research ("OGD"), may have changed its approach regarding the
conditions that must be met in order for a generic drug applicant to request a
waiver of in vivo bioequivalence testing for Vancocin. Specifically, we were
informed that a generic applicant may be able to request such a waiver provided
that dissolution testing demonstrates that the test product is rapidly
dissolving at certain specified conditions. This deviates from our understanding
of OGD's practices which would require, for a non- absorbed GI drug, a
demonstration of bioequivalence through clinical studies or a demonstration of
bioequivalence using an appropriately validated in vitro methodology.
We have attempted to contact OGD, but been unable to confirm this directly with
it. Nonetheless, we feel that it is important to note that, if such a change in
FDA's approach has occurred:
- The change would have been made in the absence of any public
discussion and, significantly, without seeking input from FDA's own
expert Advisory Committee on this important issue;
- We believe that there are important safety and scientific issues that
the FDA must consider before making such an important change in its
requirements for bioequivalence data; and
- We strongly disagree with both the manner in which this change in
approach was developed, as well as the substance of the approach which
ignores the need to demonstrate bioequivalence for a non-systemically
absorbed drug. We will vigorously oppose at FDA this attempt to
radically restrict the data on which FDA would make vancomycin capsule
bioequivalence decisions. Vancocin combats a serious, and potentially
life threatening, disease. In this context, we believe that the
uncertainties of dissolution-only bioequivalence are simply
unacceptable.
C. difficile is a bacterium, which under certain circumstances, typically after
antibiotic therapy, can colonize the lower gastrointestinal tract where it may
produce toxins which cause inflammation of the colon and diarrhea, and the
associated complications of disease. Advanced age, gastrointestinal
surgery/manipulation, long length of stay in healthcare settings, a serious
underlying illness and compromised immunity are conditions associated with
increased risk of disease. According to the CDC, there are approximately
3,000,000 cases of antibiotic-associated diarrhea per year, of which 15 to 25
percent are caused by C. difficile.
