title: Change in formulation and its potential clinical and pharmacoeconomic value: example of extended release venlafaxine.
abstract: BACKGROUND
  The 505(b)(2) route of a New Drug Application (NDA) allows published literature or previous FDA findings of safety and effectiveness to be used for approval. Such drugs are not therapeutic equivalents (i.e., generics); instead, the FDA calls them pharmaceutical alternatives. A recent example is the approval of venlafaxine extended-release (ER) tablets, developed as an alternative to the widely used ER venlafaxine capsules. The smaller size of the tablets makes them available in a 225-mg strength, which is the approved maximum dose in major depressive disorder after up-titration but currently unavailable in the capsule formulation, requiring patients on this dose to take two or three capsules; in addition, the tablets are priced at a discount compared to the capsules.
  
  
  METHODS
  The objective of this review was to investigate how the change in formulation of ER venlafaxine from capsules to tablets, as an example of such a change in formulation, can potentially offer value to patients and society, with a specific focus on pill burden, drug cost, and adherence. Based on a MEDLINE literature search, the pertinent literature was reviewed in a qualitative manner.
  
  
  METHODS
  Simplifying treatment regimens, reducing pill burden, and reducing drug costs are recognized strategies for improving adherence. This can be of particular benefit in psychiatric illness because of high rates of nonadherence to treatment. Lack of adherence may negatively impact treatment outcomes and increase disease cost. As such, the ER venlafaxine tablets have the potential to reduce pill burden, improve adherence and outcomes, and reduce cost to patients and society. These preliminary findings need to be corroborated with more primary research and a systematic review of formulation changes.
  
  
  CONCLUSIONS
  A change in formulation of established therapies such as ER venlafaxine has the potential to offer clinical and pharmacoeconomic benefits to patients and society.
authors.affiliation: UCB, Inc., Smyrna, GA 30080, USA. jean-marc.haeusler@ucb.com
authors.forename: Jean-Marc C
authors.initials: JM
authors.lastname: Haeusler
mesh_terms: D003511:Cyclohexanols / Q000008:administration & dosage* / Q000191:economics; D003692:Delayed-Action Preparations / Q000191:economics; D004305:Dose-Response Relationship, Drug; D004339:Drug Compounding / Q000191:economics* / Q000379:methods*; D004358:Drug Therapy / Q000191:economics* / Q000379:methods; D006801:Humans; D008954:Models, Biological; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence; D000069470:Venlafaxine Hydrochloride
chemical_list: D003511:Cyclohexanols; D003692:Delayed-Action Preparations; D000069470:Venlafaxine Hydrochloride