Drug intelligence / Profile preview

nefopam hydrochloride + paracetamol

Development stage
Phase 4
Lead developer
Unither Pharmaceuticals
Modality
Small Molecules
Administration
Oral
01

Overview

Nefopam hydrochloride + paracetamol is an oral fixed-dose analgesic combination containing **nefopam hydrochloride 30 mg** and **paracetamol 500 mg** per tablet. It was developed by Unither for short-term symptomatic treatment of moderate to severe somatic acute pain, including pain after impacted third-molar extraction. Nefopam is a centrally acting non-opioid analgesic with monoamine reuptake-inhibitory activity, while paracetamol provides central analgesic and antipyretic activity that is partly associated with cyclooxygenase inhibition. The combination is intended to provide multimodal, potentially synergistic analgesia while limiting exposure to either component alone. Unither evaluated the product in a randomized Phase 3 trial in postoperative dental pain and in a separate pharmacokinetic study in healthy volunteers. ([cdn.clinicaltrials.gov](https://cdn.clinicaltrials.gov/large-docs/35/NCT04622735/Prot_SAP_000.pdf))

Brand names
nefopam + paracetamol
Other names
nefopam + paracetamolnefopam hydrochloride + paracetamolnefopam hydrochloride/paracetamolnefopam/paracetamol
02

Targets

PTGS2 (Prostaglandin-Endoperoxide Synthase 2)DAT (Dopamine plasma membrane transport protein)NET (Norepinephrine Transporter)SERT (Sodium-dependent serotonin transporter)

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