Last reviewed 2026-04-22 · How we verify

Etodolac-lidocaine topical patch

MEDRx USA, Inc. · Phase 3 active Small molecule

Etodolac-lidocaine topical patch is a NSAID/local anesthetic combination Small molecule drug developed by MEDRx USA, Inc.. It is currently in Phase 3 development for Localized musculoskeletal pain and inflammation, Osteoarthritis pain (localized). Also known as: Etoreat.

Etodolac-lidocaine topical patch delivers a nonsteroidal anti-inflammatory drug (NSAID) and local anesthetic directly to affected tissue to reduce pain and inflammation.

Etodolac-lidocaine topical patch delivers a nonsteroidal anti-inflammatory drug (NSAID) and local anesthetic directly to affected tissue to reduce pain and inflammation. Used for Localized musculoskeletal pain and inflammation, Osteoarthritis pain (localized).

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Etodolac-lidocaine topical patch
Also known as	Etoreat
Sponsor	MEDRx USA, Inc.
Drug class	NSAID/local anesthetic combination
Target	COX-2 (etodolac); voltage-gated sodium channels (lidocaine)
Modality	Small molecule
Therapeutic area	Pain Management
Phase	Phase 3

Mechanism of action

Etodolac is a selective COX-2 inhibitor that reduces prostaglandin synthesis and inflammation at the site of application. Lidocaine is a local anesthetic that blocks sodium channels and provides rapid pain relief. The combination patch allows both agents to penetrate the skin and provide localized analgesic and anti-inflammatory effects without systemic absorption.

Approved indications

Localized musculoskeletal pain and inflammation
Osteoarthritis pain (localized)

Common side effects

Application site irritation or erythema
Pruritus at application site
Contact dermatitis

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Etodolac-lidocaine topical patch CI brief — competitive landscape report
Etodolac-lidocaine topical patch updates RSS · CI watch RSS
MEDRx USA, Inc. portfolio CI

Frequently asked questions about Etodolac-lidocaine topical patch

What is Etodolac-lidocaine topical patch?

Etodolac-lidocaine topical patch is a NSAID/local anesthetic combination drug developed by MEDRx USA, Inc., indicated for Localized musculoskeletal pain and inflammation, Osteoarthritis pain (localized).

How does Etodolac-lidocaine topical patch work?

Etodolac-lidocaine topical patch delivers a nonsteroidal anti-inflammatory drug (NSAID) and local anesthetic directly to affected tissue to reduce pain and inflammation.

What is Etodolac-lidocaine topical patch used for?

Etodolac-lidocaine topical patch is indicated for Localized musculoskeletal pain and inflammation, Osteoarthritis pain (localized).

Who makes Etodolac-lidocaine topical patch?

Etodolac-lidocaine topical patch is developed by MEDRx USA, Inc. (see full MEDRx USA, Inc. pipeline at /company/medrx-usa-inc).

Is Etodolac-lidocaine topical patch also known as anything else?

Etodolac-lidocaine topical patch is also known as Etoreat.

What drug class is Etodolac-lidocaine topical patch in?

Etodolac-lidocaine topical patch belongs to the NSAID/local anesthetic combination class. See all NSAID/local anesthetic combination drugs at /class/nsaid-local-anesthetic-combination.

What development phase is Etodolac-lidocaine topical patch in?

Etodolac-lidocaine topical patch is in Phase 3.

What are the side effects of Etodolac-lidocaine topical patch?

Common side effects of Etodolac-lidocaine topical patch include Application site irritation or erythema, Pruritus at application site, Contact dermatitis.

What does Etodolac-lidocaine topical patch target?

Etodolac-lidocaine topical patch targets COX-2 (etodolac); voltage-gated sodium channels (lidocaine) and is a NSAID/local anesthetic combination.

Drug class: All NSAID/local anesthetic combination drugs
Target: All drugs targeting COX-2 (etodolac); voltage-gated sodium channels (lidocaine)
Manufacturer: MEDRx USA, Inc. — full pipeline
Therapeutic area: All drugs in Pain Management
Indication: Drugs for Localized musculoskeletal pain and inflammation
Indication: Drugs for Osteoarthritis pain (localized)
Also known as: Etoreat

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing