Low-dose SoluMatrix diclofenac: A review of safety across two Phase III studies in patients with acute and osteoarthritis pain

Allan Gibofsky, Roy D Altman, Stephen Daniels, Olaolu Imasogie, Clarence Young

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Introduction: Similar to other NSAIDs, diclofenac is associated with serious dose-related cardiovascular, gastrointestinal, and renal adverse events. Low-dose SoluMatrix diclofenac, containing submicron particles of diclofenac, was developed to provide effective analgesia at lower drug doses compared with currently available NSAIDs.Areas covered: The efficacy and safety of low-dose SoluMatrix diclofenac was evaluated in two randomized, placebo-controlled Phase III studies: a study in patients with acute pain following bunionectomy surgery and a study in patients with osteoarthritis pain of the hip or knee. In this review article, we summarize safety data from these studies.Expert opinion: The safety results from the Phase III studies indicate that all dosing regimens of low-dose SoluMatrix diclofenac up to 12 weeks are generally well tolerated. Few serious gastrointestinal, cardiovascular, renal, or hepatic adverse events commonly associated with NSAID use were reported in these studies. Although not directly compared, the safety of SoluMatrix diclofenac was similar to findings for other diclofenac drug products. The potential for safe and effective management of acute and chronic pain at reduced NSAID doses is attractive; definitive characterization of SoluMatrix diclofenac safety requires confirmation by long-term studies.

Original languageEnglish (US)
Pages (from-to)1327-1339
Number of pages13
JournalExpert Opinion on Drug Safety
Volume14
Issue number8
DOIs
StatePublished - Aug 1 2015
Externally publishedYes

Fingerprint

Diclofenac
Acute Pain
Osteoarthritis
Safety
Non-Steroidal Anti-Inflammatory Agents
Kidney
Hip Osteoarthritis
Knee Osteoarthritis
Expert Testimony
Chronic Pain
Pharmaceutical Preparations
Analgesia
Placebos
Pain
Liver

Keywords

  • Acute pain
  • Diclofenac
  • Osteoarthritis
  • Safety
  • SoluMatrix

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Low-dose SoluMatrix diclofenac : A review of safety across two Phase III studies in patients with acute and osteoarthritis pain. / Gibofsky, Allan; Altman, Roy D; Daniels, Stephen; Imasogie, Olaolu; Young, Clarence.

In: Expert Opinion on Drug Safety, Vol. 14, No. 8, 01.08.2015, p. 1327-1339.

Research output: Contribution to journalArticle

Gibofsky, Allan ; Altman, Roy D ; Daniels, Stephen ; Imasogie, Olaolu ; Young, Clarence. / Low-dose SoluMatrix diclofenac : A review of safety across two Phase III studies in patients with acute and osteoarthritis pain. In: Expert Opinion on Drug Safety. 2015 ; Vol. 14, No. 8. pp. 1327-1339.
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