A phase 2 study of naproxen submicron particle capsules in patients with post-surgical dental pain

Clarence L. Young, Vibeke Strand, Roy Altman, Stephen Daniels

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Background: Naproxen is an NSAID with documented efficacy in pain management; however, it is associated with serious dose-related adverse events. A lower-dose naproxen drug product with comparable efficacy to commercially available naproxen could address these concerns. We studied the efficacy and safety of naproxen submicron particle capsules in patients with acute post-surgical dental pain. Methods: A phase 2, multicenter, randomized, single-dose study (NCT01229228) enrolled 254 patients (18-34 years old) undergoing third molar extraction. Patients who experienced moderate-to-severe pain ≤6 h following surgery received naproxen submicron particle capsules 200 or 400 mg, naproxen tablets 250 or 500 mg, or placebo. The primary efficacy parameter was patient-reported total pain relief over 0-12 h following administration of study medication. Secondary efficacy parameters included patient-reported total pain relief over 0-4 and 0-8 h; pain intensity assessments from 0 to 4, 0 to 8, and 0 to 12 h; and time to onset of analgesia. Safety and tolerability were also assessed. Results: Naproxen submicron particle capsules 200 mg (25.9 ± 2.0; 95% CI 21.9-29.8), naproxen tablets 250 mg (24.4 ± 2.0; 95% CI 20.4-28.3), naproxen submicron particle capsules 400 mg (31.9 ± 2.0; 95% CI 28.1-35.8), and naproxen tablets 500 mg (28.5 ± 2.0; 95% CI 24.7-32.4) groups experienced greater pain relief over 12 h compared with placebo (P < 0.001). Similar trends were observed for secondary outcomes of total pain relief over 0-4, 0-8 h, and time to onset of analgesia. Adverse events were generally similar across all treatment groups. Conclusion: Lower-dose naproxen submicron particle capsules provided effective analgesia in acute post-surgical dental pain and warrant further evaluation as a potentially promising treatment for acute pain conditions.

Original languageEnglish (US)
Pages (from-to)885-896
Number of pages12
JournalAdvances in Therapy
Volume30
Issue number10
DOIs
StatePublished - Oct 1 2013

Keywords

  • Acute pain
  • Dental pain
  • NSAID
  • Naprosyn
  • Naproxen submicron particle capsules
  • Naproxen tablets
  • Phase 2
  • Post-operative
  • SoluMatrix

ASJC Scopus subject areas

  • Pharmacology (medical)

Fingerprint Dive into the research topics of 'A phase 2 study of naproxen submicron particle capsules in patients with post-surgical dental pain'. Together they form a unique fingerprint.

Cite this