Paroxetine mesylate: comparable to paroxetine hydrochloride?

Abstract

Importance of the field: Currently available small case reports clearly propose that existing regulatory procedures to approve generic versions only require essential bioequivalence, have limitations and fail to meet stricter scientific and clinical demands.

Areas covered in this review: Data indicate that paroxetine mesylate has some potential differences in bio- and clinical equivalence compared with paroxetine hydrochloride, although it has not been fully and sufficiently investigated in well-designed clinical trials. Data available now regarding safety, tolerability, efficacy and practical issues dealing with debates between generic and brand-name products paroxetine mesylate and paroxetine hydrochloride are presented in the review.

What the reader will gain: Preclinical and clinical data are reviewed, and clinical issues relating to use of generic version versus original product are comprehensively discussed; tips for the clinician in clinical practice are also provided.

Take home message: Potential differences in efficacy and safety but also reduction in the use of health care and in pharmacy cost should be considered when choosing the generic version or the original product based on the clear benefit–risk ratio in patients.

Keywords::

• brand-name product
• generic
• paroxetine hydrochloride
• paroxetine mesylate
• safety
• tolerability

Acknowledgment

This work was supported by grants from the Medical Research Center, Korea Science and Engineering Foundation, Republic of Korea (R13-2002-005-04001-0).

Notes

This box summarises key points contained in the article.