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505(b)(2) with Only Phase 1 Study

We are often asked if a 505(b)(2) application always requires a clinical study (i.e., Phase 2 or 3 in patients).  The answer is a resounding NO.

On January 14, 2008 ADVENTRX Pharmaceuticals announced the successful completion of a bioequivalence study that demonstrated similar blood levels and a “statistically significant reduction in injection site reactions”.  The company further stated “the FDA has indicated that this single clinical study, should it demonstrate pharmacokinetic equivalence between ANX-530 and Navelbine, would provide sufficient clinical data to support a Section 505(b)(2) NDA.”

There you have it, another example where a well designed Phase 1 study can suffice for 505(b)(2) submission.

Remember though, ADVENTRX will not likely receive any exclusivity for this application because it did not require a clinical study for approval.  We are guessing that ADVENTRX will rely on a patent or trade secret to prevent future generic copies.  Unlike most other dosage forms, generics must copy an injectable exactly.