Document Detail

Change in formulation and its potential clinical and pharmacoeconomic value: example of extended release venlafaxine.
MedLine Citation:
PMID:  19301988     Owner:  NLM     Status:  MEDLINE    
INTRODUCTION: 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.
REVIEW OF THE LITERATURE: 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.
CONCLUSION: A change in formulation of established therapies such as ER venlafaxine has the potential to offer clinical and pharmacoeconomic benefits to patients and society.
Jean-Marc C Haeusler
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Publication Detail:
Type:  Evaluation Studies; Journal Article; Review    
Journal Detail:
Title:  Current medical research and opinion     Volume:  25     ISSN:  1473-4877     ISO Abbreviation:  Curr Med Res Opin     Publication Date:  2009 May 
Date Detail:
Created Date:  2009-04-29     Completed Date:  2009-07-23     Revised Date:  2011-08-25    
Medline Journal Info:
Nlm Unique ID:  0351014     Medline TA:  Curr Med Res Opin     Country:  England    
Other Details:
Languages:  eng     Pagination:  1089-94     Citation Subset:  IM    
UCB, Inc., Smyrna, GA 30080, USA.
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MeSH Terms
Cyclohexanols / administration & dosage*,  economics
Delayed-Action Preparations / economics
Dose-Response Relationship, Drug
Drug Compounding / economics*,  methods*
Drug Therapy / economics*,  methods
Models, Biological
United States
United States Food and Drug Administration / legislation & jurisprudence
Reg. No./Substance:
0/Cyclohexanols; 0/Delayed-Action Preparations; 93413-69-5/venlafaxine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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