Overview
Flurbiprofen, a propionic acid derivative, is a nonsteroidal anti-inflammatory agent (NSAIA) with antipyretic and analgesic activity. Oral formulations of flurbiprofen may be used for the symptomatic treatment of rheumatoid arthritis, osteoarthritis and anklylosing spondylitis. Flurbiprofen may also be used topically prior to ocular surgery to prevent or reduce intraoperative miosis. Flurbiprofen is structurally and pharmacologically related to fenoprofen, ibuprofen, and ketoprofen.
Indication
Flurbiprofen tablets are indicated for the acute or long-term symptomatic treatment of rheumatoid arthritis, osteorarthritis and anklosing spondylitis. It may also be used to treat pain associated with dysmenorrhea and mild to moderate pain accompanied by inflammation (e.g. bursitis, tendonitis, soft tissue trauma). Topical ophthalmic formulations may be used pre-operatively to prevent intraoperative miosis.
Associated Conditions
- Ankylosing Spondylitis (AS)
- Back Pain, Acute
- Chronic Back Pain
- Menstrual Distress (Dysmenorrhea)
- Muscle Spasms
- Non-Articular Rheumatic Muscle Spasms
- Osteoarthritis (OA)
- Pain
- Pain, Inflammatory
- Post Traumatic Pain
- Postoperative pain
- Rheumatoid Arthritis
- Spinal pain
Research Report
Flurbiprofen (DB00712): A Comprehensive Pharmacological and Clinical Monograph
I. Introduction and Drug Profile
1.1. Overview and Classification
Flurbiprofen is a potent small molecule drug classified as a nonsteroidal anti-inflammatory drug (NSAID).[1] It is a member of the phenylalkanoic acid derivative family and, more specifically, a propionic acid derivative. This classification places it in the same chemical and pharmacological class as other widely used NSAIDs such as ibuprofen, naproxen, and ketoprofen.[1] As a member of this class, Flurbiprofen exhibits a triad of core therapeutic actions: anti-inflammatory, analgesic (non-narcotic), and antipyretic properties, making it a versatile agent for the management of a spectrum of conditions characterized by pain and inflammation.[1]
The drug's development traces back to the highly productive research period of the 1960s at the research arm of Boots UK, which also yielded the discovery of several other foundational NSAIDs, including ibuprofen.[2] Flurbiprofen was patented in 1964 and, following extensive clinical development, received its initial approval for medical use in 1987, with approval in the United States by the Food and Drug Administration (FDA) following in 1988.[2] This historical context establishes Flurbiprofen as one of the classic, well-characterized NSAIDs that form the bedrock of anti-inflammatory pharmacotherapy. It is available in diverse formulations, including oral tablets for systemic conditions, ophthalmic solutions for ocular surgery, and oromucosal preparations for localized throat pain, reflecting its broad clinical utility.[1]
1.2. Chemical Identity and Physicochemical Properties
A thorough understanding of Flurbiprofen's chemical and physical characteristics is fundamental to appreciating its formulation, pharmacokinetic behavior, and interaction with biological systems.
Nomenclature and Structure
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/11/03 | Not Applicable | Not yet recruiting | |||
2025/09/09 | Not Applicable | Not yet recruiting | Kittitorn Supphapipat, MD | ||
2024/08/22 | Not Applicable | Not yet recruiting | |||
2024/08/01 | Not Applicable | Not yet recruiting | Beijing Tiantan Hospital | ||
2024/02/02 | Phase 4 | Completed | Yuzuncu Yıl University | ||
2023/09/18 | Phase 4 | Completed | |||
2023/08/21 | Not Applicable | Completed | |||
2023/08/08 | Phase 1 | Completed | |||
2023/07/21 | Early Phase 1 | Completed | |||
2023/07/06 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| NuCare Pharmaceuticals,Inc. | 68071-2480 | ORAL | 100 mg in 1 1 | 7/20/2021 | |
| Medsource pharmaceuticals | 45865-918 | ORAL | 100 mg in 1 1 | 2/29/2024 | |
| Teva Pharmaceuticals USA, Inc. | 0093-0711 | ORAL | 100 mg in 1 1 | 11/30/2021 | |
| Rebel Distributors Corp | 42254-023 | OPHTHALMIC | 0.3 mg in 1 mL | 6/2/2011 | |
| NuCare Pharmaceuticals,Inc. | 68071-4436 | ORAL | 100 mg in 1 1 | 2/16/2021 | |
| PD-Rx Pharmaceuticals, Inc. | 43063-992 | ORAL | 100 mg in 1 1 | 3/31/2023 | |
| STAT RX USA LLC | 16590-096 | ORAL | 100 mg in 1 1 | 5/15/2009 | |
| Bryant Ranch Prepack | 63629-8808 | ORAL | 100 mg in 1 1 | 11/30/2021 | |
| Proficient Rx LP | 63187-937 | OPHTHALMIC | 0.3 mg in 1 mL | 12/1/2018 | |
| Rebel Distributors Corp | 21695-615 | OPHTHALMIC | 0.242 mg in 1 mL | 3/4/2008 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| STREPSILS MAX PRO DIRECT SPRAY 8.75MG PER DOSE | SIN15370P | SPRAY | 8.7480mg/dose | 11/29/2017 | |
| ACUSTOP CATAPLASMA PLASTER 40 mg/sheet | SIN12090P | PATCH | 40 mg/sheet | 9/30/2002 | |
| Strepsils MaxPro Honey and Lemon lozenges 8.75mg | SIN14364P | LOZENGE | 8.75mg | 6/11/2013 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| SULAN TABLETS 100MG | N/A | N/A | N/A | 9/4/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| STREPFEN ANTI-INFLAMMATORY flurbiprofen 8.75 mg orange flavour lozenge blister pack (reformulation) | 157020 | Medicine | A | 11/19/2008 | |
| STREPFEN ANTI-INFLAMMATORY THROAT SPRAY flurbiprofen 8.75 mg/0.54 mL solution pump actuated metered dose aerosol | 259957 | Medicine | A | 9/11/2015 | |
| STREPFEN ANTI-INFLAMMATORY flurbiprofen 8.75 mg honey & lemon flavour lozenge blister pack | 133376 | Medicine | A | 12/1/2007 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| RATIO-FLURBIPROFEN TABLETS 100MG | ratiopharm inc division of teva canada limited | 00675199 | Tablet - Oral | 100 MG | 12/31/1991 |
| NOVO-FLURPROFEN SR | novopharm limited | 02237859 | Capsule (Sustained-Release) - Oral | 200 MG / SRC | N/A |
| RATIO-FLURBIPROFEN TABLETS 50MG | ratiopharm inc division of teva canada limited | 00675202 | Tablet - Oral | 50 MG | 12/31/1991 |
| NU-FLURBIPROFEN TAB 50MG | nu-pharm inc | 02020661 | Tablet - Oral | 50 MG | 12/31/1993 |
| FLURBIPROFEN | aa pharma inc | 01912046 | Tablet - Oral | 50 MG | 12/31/1991 |
| TEVA-FLURBIPROFEN | teva canada limited | 02100517 | Tablet - Oral | 100 MG | 12/31/1994 |
| OCUFEN OPH SOLN 0.03% | 00766046 | Liquid - Ophthalmic | 0.03 % | 12/31/1988 | |
| ANSAID TABLETS 50 MG | 00647942 | Tablet - Oral | 50 MG | 12/31/1985 | |
| FROBEN SR | ABBOTT LABORATORIES, LIMITED | 02223082 | Capsule (Sustained-Release) - Oral | 200 MG | 1/28/1997 |
| ANSAID TABLETS 100 MG | 00600792 | Tablet - Oral | 100 MG | 12/31/1985 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ANGIFEN 8,75 MG PASTILLAS PARA CHUPAR SABOR MENTA | Alfasigma España, S.L. | 81911 | PASTILLA PARA CHUPAR | Sin Receta | Commercialized |
| LIZIFEN 8,75 MG PASTILLAS PARA CHUPAR SABOR MIEL Y LIMON | Opella Healthcare Spain S.L. | 81912 | PASTILLA PARA CHUPAR | Sin Receta | Commercialized |
| STREFEN 8,75 MG PASTILLAS PARA CHUPAR SABOR NARANJA | Reckitt Benckiser Healthcare S.A. | 76902 | PASTILLA PARA CHUPAR | Sin Receta | Commercialized |
| STREGAR 8,75 MG PASTILLAS PARA CHUPAR SABOR NARANJA | Reckitt Benckiser Healthcare S.A. | 86799 | PASTILLA PARA CHUPAR | Sin Receta | Not Commercialized |
| TANTUFEN 8,75 MG PASTILLAS PARA CHUPAR SABOR LIMON | Angelini Pharma Espana S.L. | 86682 | PASTILLA PARA CHUPAR | Sin Receta | Not Commercialized |
| STREFEN SPRAY 8,75 MG/DOSIS SOLUCION PARA PULVERIZACION BUCAL SABOR MENTA | Reckitt Benckiser Healthcare S.A. | 79428 | SOLUCIÓN PARA PULVERIZACIÓN BUCAL | Sin Receta | Commercialized |
| FLURBIPROFENO SEJMET 8,75 MG/DOSIS SOLUCION PARA PULVERIZACION BUCAL | Sejmet Pharmaceuticals S.L. | 83997 | SOLUCIÓN PARA PULVERIZACIÓN BUCAL | Sin Receta | Not Commercialized |
| FLURBIPROFENO SANDOZ CARE 8,75 MG PASTILLAS PARA CHUPAR SABOR NARANJA | Sandoz Farmaceutica S.A. | 81995 | PASTILLA PARA CHUPAR | Sin Receta | Not Commercialized |
| STREFEN 8,75 MG PASTILLAS PARA CHUPAR SABOR MIEL Y EUCALIPTO | Reckitt Benckiser Healthcare S.A. | 86532 | PASTILLA PARA CHUPAR | Sin Receta | Commercialized |
| STREFEN 8,75 mg PASTILLAS PARA CHUPAR SABOR MIEL Y LIMON | Reckitt Benckiser Healthcare S.A. | 72938 | PASTILLA PARA CHUPAR | Sin Receta | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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