Fixed-Dose Combination Acetaminophen/Ibuprofen for Postoperative Dental Pain

PainRelief.com Interview with:

Prof Chris Frampton PhD Department of Medicine University of Otago Christchurch, New Zealand

Prof. Frampton

Prof Chris Frampton PhD
Department of Medicine
University of Otago
Christchurch, New Zealand

PainRelief.com: What is the background for this study?

Response: Acute pain is a significant burden to the individual and to society. In light of the ongoing opioid crisis, there is a need for effective nonopioid pain medications that provide improved analgesia over common analgesics, without compromising tolerability. Multimodal analgesia combines multiple drugs with different mechanisms of action to improve pain relief while limiting side effects. Fixed-dose combination tablets containing acetaminophen and ibuprofen are already available in many countries; however, the therapeutic advantages of such products are not available to patients in the United States. The US Food and Drug Administration (FDA) has restricted the dose of acetaminophen in prescription drugs to 325 mg per tablet, therefore an existing product containing acetaminophen 500 mg + ibuprofen 150 mg per tablet (two tablets per dose) has been downscaled to comply with FDA restrictions (acetaminophen 325 mg + ibuprofen 97.5 mg, three tablets per dose). The goal of this study was to determine the efficacy of the new fixed-dose combination of acetaminophen 975 mg and ibuprofen 292.5 mg (FDC 975/292.5) relative to acetaminophen or ibuprofen monotherapy, or placebo following the surgical removal of at least two impacted third molars.

PainRelief.com:? What are the main findings?

Response: The primary end point was the time-adjusted sum of pain intensity differences over 48 hours, which was found to be significantly greater for FDC 975/292.5 than for both monotherapies and placebo (all, P < 0.001). Statistical superiority of the combination was evident in all secondary end points (time to meaningful pain relief, maximum pain score, response rate, participants using supplementary opioid analgesia, time to rescue, oxycodone consumption, and categorical pain relief score) with the exception of time to perceptible pain relief versus monotherapies and the time to peak response versus ibuprofen. The percentage of patients reporting adverse events was 37.3% in the FDC 975/292.5 group, with no significant differences between treatment groups. Nausea was the most common adverse event across all groups.

PainRelief.com: What should readers take away from your report?

Response: The fixed-dose combination of acetaminophen and ibuprofen provided greater and more rapid analgesia than comparable doses of either agent alone or placebo in adults after removal of impacted third molars. The superior analgesia associated with the fixed-dose combination was provided without compromising the well-established safety profile of both active constituents.

PainRelief.com: What recommendations do you have for future research as a result of this work?

Response: The findings of the present study are limited to adults and to a dental pain model – future studies could investigate other study populations, or routes of administration. Based on the existing literature, it is expected that this fixed-dose combination would be effective in other pain models. 

PainRelief.com: Is there anything else you would like to add?

Response: The study was funded by AFT Pharmaceuticals Ltd., Auckland, New Zealand. The sponsor was involved in the study design; collection, analysis and interpretation of the data; in the writing of the manuscript and in the decision to submit the manuscript for publication. Dr Atkinson is the majority owner and Managing Director of AFT Pharmaceuticals Ltd. and holds patents relevant to the work. Ms Stanescu is an employee and shareholder of AFT Pharmaceuticals Ltd.

Citation:

Clin Ther. 2018 Sep 20. pii: S0149-2918(18)30382-5. doi: 10.1016/j.clinthera.2018.08.019. [Epub ahead of print]

Analgesic Efficacy of an Acetaminophen/Ibuprofen Fixed-Dose Combination in Moderate to Severe Postoperative Dental Pain: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial.

Daniels SE1, Atkinson HC2, Stanescu I2, Frampton C3. 

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