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Benzocaine Otic Solution
Benzocaine Otic Solution is a Local anesthetic Small molecule drug developed by Lachlan Pharma Holdings. It is currently in Phase 3 development for Otalgia (ear pain) / acute otitis media pain relief.
Benzocaine is a local anesthetic that blocks sodium channels in nerve cell membranes to prevent pain signal transmission in the ear.
Benzocaine Otic Solution is a small molecule topical anesthetic used to treat pain. It is indicated for the treatment of acute otitis media in children, as shown in a Phase III clinical trial (NCT03116737).
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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).
| 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 | Benzocaine Otic Solution |
|---|---|
| Sponsor | Lachlan Pharma Holdings |
| Drug class | Local anesthetic |
| Target | Voltage-gated sodium channels |
| Modality | Small molecule |
| Therapeutic area | Otology / Pain Management |
| Phase | Phase 3 |
Mechanism of action
Benzocaine works by inhibiting sodium influx through nerve cell membranes, which stabilizes the neuronal membrane and prevents the initiation and conduction of nerve impulses. When applied topically to the ear canal, it rapidly numbs the affected tissue, providing local anesthetic relief. This mechanism makes it effective for otalgia (ear pain) and related otologic conditions.
Approved indications
- Otalgia (ear pain) / acute otitis media pain relief
Common side effects
- Local irritation or burning sensation
- Allergic contact dermatitis
- Methemoglobinemia (rare, with excessive use)
Key clinical trials
- Cryotherapy as a Topical Anesthetic in Healthy Children (PHASE4)
- Topical Cryoanesthesia Versus Benzocaine in Pediatric Dentistry (PHASE3)
- Intrauterine Device Insertion Pain Management (PHASE4)
- Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media (PHASE2)
- Effectiveness of Pre-administered Natural Sweet-tasting Solution (Honey) for Decreasing Pain of Needle Insertion (NA)
- Assessing the Efficacy of CREWS01 to Decrease Usage of Rescue Inhalers in Moderate to Severe Asthmatic Adults (PHASE2)
- Role of the Foregut in Nutrient Metabolism in Lean and Obese Humans (PHASE1)
- Effect of Different Approaches of Delivering Local Dental Anesthesia on Pain Perception in Children. (NA)
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:
- Benzocaine Otic Solution CI brief — competitive landscape report
- Benzocaine Otic Solution updates RSS · CI watch RSS
- Lachlan Pharma Holdings portfolio CI
Frequently asked questions about Benzocaine Otic Solution
What is Benzocaine Otic Solution?
How does Benzocaine Otic Solution work?
What is Benzocaine Otic Solution used for?
Who makes Benzocaine Otic Solution?
What drug class is Benzocaine Otic Solution in?
What development phase is Benzocaine Otic Solution in?
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What does Benzocaine Otic Solution target?
Related
- Drug class: All Local anesthetic drugs
- Target: All drugs targeting Voltage-gated sodium channels
- Manufacturer: Lachlan Pharma Holdings — full pipeline
- Therapeutic area: All drugs in Otology / Pain Management
- Indication: Drugs for Otalgia (ear pain) / acute otitis media pain relief
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing