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505(b)(2) Combo Plavix/Prilosec

Cogentus Pharmaceuticals is working on a combination tablet that combines clopidogrel, the active ingredient in Plavix, with omeprazole, the API in Prilosec. Cogentus’s business strategy is to:

“… improv[e] the therapeutic profiles of existing, proven drugs in ways that take full advantage of their strengths while overcoming their well understood limitations. By combining complementary characteristics of two or more drugs we create new products that have additive or synergistic impact.”

In this case, Plavix is an effective drug but is associated with gastro-intestinal bleeding. Cogentus hopes that omeprazole will reduce the bleeding.

Cogentus announced that they need to conduct 2 Phase 3 trials.  While many 505(b)(2) development programs require just a  single Phase 3 trial, in this case Cogentus is seeking a new indication and also must prove that the product is safer. The single trial scenario is limited to those cases where we are just confirming safety and efficacy.