Efficacy of single-dose, extended-release naproxen sodium 660 mg in postsurgical dental pain: two double-blind, randomized, placebo-controlled trials

Laurora, Irene; An, Robert

doi:10.1185/03007995.2015.1123680

Cited by 4 publications

(6 citation statements)

References 13 publications

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“…Notably, muscle injury and post-dental-surgery pain provide an invaluable bridge for assessing the efficacy of analgesics in managing LBP, bolstering the body of evidence supporting the effectiveness of NSAIDs for this condition. Since NSAIDs have both analgesic and anti-inflammatory properties, it comes as no surprise that they are effective for relieving pain across various pain conditions, including muscle soreness and dental pain [26,30,32,53,[67][68][69][70][71][72][73][74]. This is consistent with the current labeling of OTC naproxen sodium which is indicated for the temporary relief of minor aches and pains due to both toothache and muscular ache.…”

Section: Leveraging the Muscle Injury And Post-dentalsurgery Pain Mod...supporting

confidence: 54%

“…Multiple studies confirm that OTC doses of NSAIDs, including naproxen sodium and ibuprofen, effectively relieve post-surgical dental pain [ 26 , 30 , 68 , 71 ]. In one study, the analgesic efficacy of naproxen sodium (440 mg), acetaminophen (1,000 mg), and placebo were compared in a single-dose, randomized, double-blind, 12-h study with patients with at least moderate pain secondary to extraction of three or four-third molars.…”

Section: Pharmacological Analgesicsmentioning

confidence: 99%

“…It was reported that naproxen sodium (220 mg tid) and the novel ER formulation (660 mg) comparably and significantly reduced moderate to severe dental pain as compared to placebo. Significant pain relief was experienced from 15 min and sustained over 24 h, resulting in a reduced need for rescue medication [ 71 ]. Cooper et al (2022) compared a single dose of naproxen sodium (440 mg) against hydrocodone plus acetaminophen (10/650 mg) in post-impaction surgery pain.…”

Section: Pharmacological Analgesicsmentioning

confidence: 99%

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What a pain in the … back: a review of current treatment options with a focus on naproxen sodium

Weisman,

Ciavarra,

Cooper

2024

J. pharm. pharm. sci.

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Non-specific low back pain (LBP) represents a challenging and prevalent condition that is one of the most common symptoms leading to primary care physician visits. While established guidelines recommend prioritizing non-pharmacological approaches as the primary course of action, pharmacological treatments are advised when non-pharmacological approaches are ineffective or based on patient preference. These guidelines recommend non-steroidal anti-inflammatory drugs (NSAIDs) or skeletal muscle relaxers (SMRs) as the first-line pharmacological options for acute or subacute LBP, while NSAIDs are the exclusive first-line pharmacological option for chronic LBP. Although SMRs are generally effective for acute LBP, the available evidence does not support the view that they improve functional recovery, and their comparative efficacy to NSAIDs and other analgesics remains unknown, while studies have shown them to introduce adverse events without significantly reducing LBP. Moreover, opioids continue to be widely prescribed for LBP, despite limited evidence for effectiveness and known risks of addiction and overdose. Broader use of non-opioid pharmacotherapy, including the appropriate use of OTC options, is critical to addressing the opioid crisis. The balance of evidence indicates that NSAIDs have a favorable benefit-risk profile when compared to other available pharmacological treatment options for non-specific LBP, a condition that is primarily acute in nature and well-suited for self-treatment with OTC analgesics. While clinical guidelines do not differentiate between NSAIDs, evidence indicates that OTC naproxen sodium effectively relieves pain across multiple types of pain models, and furthermore, the 14-h half-life of naproxen sodium allows sustained, all day pain relief with reduced patient pill burden as compared to shorter acting options. Choosing the most appropriate approach for managing LBP, including non-pharmacological options, should be based on the patient’s condition, severity of pain, potential risks, and individual patient preference and needs.

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Section: Leveraging the Muscle Injury And Post-dentalsurgery Pain Mod...supporting

confidence: 54%

Section: Pharmacological Analgesicsmentioning

confidence: 99%

Section: Pharmacological Analgesicsmentioning

confidence: 99%

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What a pain in the … back: a review of current treatment options with a focus on naproxen sodium

Weisman,

Ciavarra,

Cooper

2024

J. pharm. pharm. sci.

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“…NSAIDs, including Nx, are effective anti-inflammatory agents and are among the most commonly used classes of medications worldwide 46 . Naproxen has been prescribed for several decades to treat conditions, such as postoperative dental pain 22 , primary dysmenorrhea 23,47 , and back pain 24,48 . The most common adverse effects are heartburn, nausea, and vomiting 48 .…”

Section: Discussionmentioning

confidence: 99%

“…Nx is a non-steroidal anti-inflammatory drug that is widely available over-the-counter (OTC). This drug is effective in different pain models, such as postoperative dental pain 22 , primary dysmenorrhea 23 , back pain 24 , rheumatoid arthritis and OA 25,26 . Naproxen pretreatment inhibits NF-kB activation within IL-1b-induced chondrocytes 27 and significantly reduces IL-6 production by human OA synovial tissue fibroblasts 28 .…”

Section: Introductionmentioning

confidence: 99%

Anti-inflammatory effects of naproxen sodium on human osteoarthritis synovial fluid immune cells

Hsueh

Bolognesi

Wellman

et al. 2020

Osteoarthritis and Cartilage

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Objective: To evaluate the anti-inflammatory effects of clinically relevant naproxen sodium (Nx) concentrations on human monocyte-derived macrophages in a controlled in vitro system and human primary synovial fluid (SF) cells. Design: Using phorbol 12-myristate 13-acetate, THP-1 human monocytic cells were differentiated into mature monocyte-derived macrophages in vitro then treated with Nx pre-or post-activating an inflammatory response with lipopolysaccharide (LPS) and hyaluronan (HA) fragments (n ¼ 8/group). Cell culture supernatants were assessed for NF-kB activity and prostaglandin E 2 (PGE 2 ), indicating cyclooxygenase enzyme activity. Under Duke IRB approval, primary human SF cells were collected at the time of knee joint replacement (n ¼ 19 individuals) for osteoarthritis (OA), and cultured with LPS, HA and Nx; SF cells were characterized by polychromatic flow cytometry for cell surface markers and intracellular cytokines. Result: Compared to placebo treatment of THP-1 cells, low dose Nx (corresponding 27.5e440 mg/L orally) added both pre-and post-activation with LPS/HA, significantly reduced NF-kB activity and PGE2: mean reduction to 73%, 61%, 17% and 10% of placebo, respectively. LPS/HA treatment of primary OA SF cells significantly increased the number of IL-1b producing primary monocytes and macrophages, and by 24 h the overall production of secreted cytokines (IL-1b, IL-6, IL8, and TNF-a). Low dose Nx reduced the percentage of IL-1b producing primary monocytes and macrophages. Conclusion: LPS/HA induced inflammation of THP-1 monocytic and primary human SF cells. Low dose Nx both prevented and reduced inflammatory responses of a human monocytic cell line and reduced IL-1b production by primary human SF monocytes and macrophages.

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Analgesic efficacy and safety of non-prescription doses of naproxen sodium in the management of moderate osteoarthritis of the knee or hip

Couto

Moon

Paredes-Diaz

et al. 2018

Current Medical Research and Opinion

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Efficacy of single-dose, extended-release naproxen sodium 660 mg in postsurgical dental pain: two double-blind, randomized, placebo-controlled trials

Cited by 4 publications

References 13 publications

What a pain in the … back: a review of current treatment options with a focus on naproxen sodium

What a pain in the … back: a review of current treatment options with a focus on naproxen sodium

Anti-inflammatory effects of naproxen sodium on human osteoarthritis synovial fluid immune cells

Analgesic efficacy and safety of non-prescription doses of naproxen sodium in the management of moderate osteoarthritis of the knee or hip

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