Norflex

(orphenadrine)

ApprovedSmall molecule

33M

Norflex is one of 30 small molecule programs targeting Spinal Fusion. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Spinal FusionCompleted

Muscle CrampRecruiting

Spinal FusionApproved

Completed

Muscle CrampPhase 3

Recruiting

Competition

Competitive Landscape

16 competitors in Spinal Fusion

#DrugCompanyPhaseTrials

Medrol

Pfizer

Approved

1 2

MS Contin

HHikma Pharmaceuticals LLC

Approved

4 3

Marcaine

IInnocoll

Approved

2 4

Decadron

AAspen Global Incorporated

Approved

2 5

Ultiva

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

2 6

Dilaudid

RRhodes Pharmaceuticals, L.P.

Approved

1 7

Duragesic

CCephalon

Approved

1 8

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Approved

1 9

Forteo

AAlmaject

Approved

1 10

Adrenaline

SSamson Clinical Operations Pty Ltd

Approved

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2028

Phase 3Recruiting

Muscle Cramp

NCT02423395

Clinical

Trials by Indication[1]

Muscle Cramp2 trials

Study of Orphenadrine' in the Treatment of Muscle Cramps in Patients With Cirrhosis

Recruiting·SSherief Abd-Elsalam·Phase 3·NCT02423395·100 enrolled

Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients

Terminated·MMansoura University·N/A·NCT04509336·5 enrolled

CAR1 trial

Orphenadrine and Methocarbamol for LBP

Completed·MMontefiore Medical Center·Phase 4·NCT02665286·240 enrolled

Spinal Fusion1 trial

Multi-Modal Anesthesia Protocol in Pain Management of Patients Undergoing Posterior Lumbar Spinal Fusion Surgery

Completed·UUniversity of Puerto Rico·Phase 4·NCT05413902·100 enrolled

Patient Preference1 trial

Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients

Withdrawn·WWestern Galilee Hospital-Nahariya·N/A·NCT01263652

Perioperative Pain Control1 trial

Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery

Unknown status·UUniversity of Illinois College of Medicine at Peoria·Phase 4·NCT02958566·80 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

NORFLEX

NDA NDA013055

Jan 1, 1982

NORFLEX

NDA NDA012157

Jan 1, 1982

DISIPAL

NDA NDA010653

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for orphenadrine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — orphenadrine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for orphenadrine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA013055). U.S. Food & Drug Administration.
[5]
SEC EDGAR — 3M company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: 33M

Norflex

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2028

Trials by Indication[1]

Muscle Cramp2 trials

CAR1 trial

Spinal Fusion1 trial

Patient Preference1 trial

Perioperative Pain Control1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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