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Diclofenac Sodium Bolus Injection (DylojectTM): A Review in Acute Pain Management

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Abstract

An intravenous bolus formulation of the non-steroidal anti-inflammatory drug diclofenac sodium has been developed using hydroxypropyl-β-cyclodextrin (HPβCD) as a solubility enhancer. HPβCD diclofenac (DylojectTM) is available for use in adults in the USA for the management of mild to moderate pain, and as monotherapy or in combination with opioid analgesics for the management of moderate to severe pain. In two multicentre, phase III studies in adults with acute moderate to severe postoperative pain, HPβCD diclofenac significantly reduced pain intensity and the need for rescue medication compared with placebo. In these studies, the tolerability profile of HPβCD diclofenac was generally similar to that of placebo and adverse events were mostly mild to moderate in severity. Constipation, infusion-site pain and dizziness were the most frequently reported adverse reactions occurring numerically more frequently with HPβCD diclofenac than placebo. Therapy with HPβCD diclofenac does not appear to be associated with an increased risk of cardiovascular, renal or bleeding-related adverse events versus placebo. Thus, HPβCD diclofenac extends the treatment options currently available for the management of moderate to severe postoperative pain in adults.

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Fig. 1

Reproduced from Gan et al. [9], with permission. *p < 0.05, **p ≤ 0.0001 vs. placebo

Fig. 2

Reproduced from Daniels et al. [10], with permission. *p < 0.0001 vs. placebo

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Acknowledgments

During the peer review process, the manufacturer of HPβCD diclofenac was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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  1. Springer, Private Bag 65901, Mairangi Bay 0754, Auckland, New Zealand

    Sheridan M. Hoy

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  1. Sheridan M. Hoy
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Correspondence to Sheridan M. Hoy.

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The preparation of this review was not supported by any external funding.

Conflict of interest

Sheridan Hoy is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

Additional information

The manuscript was reviewed by: A. S. Habib, Department of Anesthesiology, Duke University Medical Center, Durham, NC, USA; L. Liu, Department of Anesthesia and Perioperative Care, UC San Francisco, San Francisco, USA.

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Hoy, S.M. Diclofenac Sodium Bolus Injection (DylojectTM): A Review in Acute Pain Management. Drugs 76, 1213–1220 (2016). https://doi.org/10.1007/s40265-016-0619-7

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