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Pharma Two B's Approach

Pharma Two B is focused on development of Combination  Products, based of previously approved drugs showing synergistic effects and clinical advantages. The company's regulatory approach for registering its products is the FDA 505(b)2 pathway.

Combination Products

Our Combination Products contain two or more drugs in one dosage form, in an optimized ratio/dose, and an individually adapted release profile for each of the components.  Our Combination Products are generally formulated using either tableting or microencapsulation techniques. In the case of microencapsulation, for example, separate beads for each component, with a release profile adapted to its pharmacokinetic properties, are formulated independently and packed in one capsule.

Advantages:

  1. Increased clinical value- synergy between the drugs leads to greater therapeutic effect.
  2. Synergistic effect allows decreasing the doses of the component, leading to improved safety profile with less side effect, while maintaining high clinical outcome.
  3. Compliance- one dosage form containing both drugs, taken once daily.
  4. Basic Compounds established and accepted, leading to increased acceptance by  physicians, patients and insurance companies.
  5. Shortened regulatory pathway- 505(b)2 approach.

 

505(b)2 regulatory pathway:

505(b)2 is a regulatory pathway of the US FDA, intended for previously approved drugs, being developed for different indication, different dosage form/strength, or in combinations. This pathway is defined in the FDA as a new drug application (NDA) containing safety and efficacy studies that were not conducted by the applicant.

This pathway allows the applicant to rely on safety and efficacy findings of previously approved drugs, however requires preclinical and clinical data demonstrating that the differences from the reference drug do not compromise safety and efficacy. This approach may potentially save pharmaceutical sponsors both time and money.