You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR EPINEPHRINE; LIDOCAINE HYDROCHLORIDE


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Epinephrine; Lidocaine Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001724 ↗ Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 1997-11-01 This study will evaluate the effectiveness of the non-steroidal anti-inflammatory drug flurbiprofen (Ansaid® (Registered Trademark)) in relieving pain following oral surgery. Flurbiprofen is approved by the Food and Drug Administration for treatment of arthritis pain. Patients 16 years of age and older requiring third molar (wisdom tooth) extraction may be eligible for this study. Patients will undergo oral surgery to remove two lower third molar teeth. Before surgery, they will be given a local anesthetic (lidocaine with epinephrine) injected in the mouth and a sedative (Versed) infused through a catheter (thin plastic tube) placed in an arm vein. At the time of surgery, patients will also be given flurbiprofen or a placebo formulation (look-alike substance with no active ingredient) directly into the extraction site and a capsule that also may contain flurbiprofen or placebo. One in seven patients will receive only placebo. All patients will fill out pain questionnaires and stay in the clinic for up to 6 hours for observation of bleeding and medication side effects. Patients who do not have satisfactory pain relief from the test medicine after surgery may request a standard pain reliever. A small blood sample will be collected during surgery and at 15 minutes, one-half hour and 1, 2, 3, 4, 5, 6, 24 and 48 hours after surgery to measure flurbiprofen blood levels. A total of 33 ml (about 2 tablespoons) of blood will be drawn for these tests. Samples collected on the day of surgery will be drawn from the catheter used to administer the sedative; the 24- and 48-hour samples will be taken by needle from an arm or hand vein. Urine samples will also be collected between 4 and 6 hours after surgery and again at 24 and 48 hours after surgery.
NCT00107822 ↗ Safety Study of S-Caine Peel (Skin Numbing Cream) Before a Painful Dermatologic Procedure in Children Completed ZARS Pharma Inc. Phase 3 2005-04-01 The purpose of this study is to evaluate the safety of one treatment of S-Caine™ Peel (skin numbing cream) applied on healthy skin before a painful dermatologic procedure in children. This study will also evaluate how well the S-Caine™ Peel eases the pain of the procedure.
NCT00107835 ↗ Safety Study of S-Caine Peel (Skin Numbing Cream) Before a Painful Dermatologic Procedure in Adults Completed ZARS Pharma Inc. Phase 3 2005-05-01 The purpose of this study is to evaluate the safety of one treatment of S-Caine™ Peel (skin numbing cream) applied on healthy skin before a painful dermatologic procedure in adults. This study will also evaluate how well the S-Caine™ Peel eases the pain of the procedure.
NCT00154167 ↗ Safety and Efficacy Study of NV-101 in Dental Patients Completed Novalar Pharmaceuticals, Inc. Phase 2 2003-02-01 The purpose of this study was: - to determine if NV-101 accelerates recovery from numbness compared to placebo - to evaluate safety of NV-101
NCT00194610 ↗ Botox as a Treatment for Interstitial Cystitis in Women Completed Paul G. Allen Family Foundation Phase 4 2004-05-01 Patients with interstitial cystitis have been well documented to have pelvic floor muscle tenderness as well as pain on bladder distension. Some investigators have even suggested that pelvic floor muscle pain is primarily the cause of bladder problems. Botulinum toxin A causes muscle relaxation by inhibiting the acetylcholine release at the neuromuscular junction. It has been shown that this mechanism relieves pain in a number of muscle spasm-related syndromes. Because, at present, there is little effective therapy available for patients with interstitial cystitis, the researchers want to determine if botulinum toxin A will relieve bladder and pelvic pain in these patients.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Epinephrine; Lidocaine Hydrochloride

Condition Name

Condition Name for Epinephrine; Lidocaine Hydrochloride
Intervention Trials
Pain 24
Anesthesia, Local 11
Pain, Postoperative 9
Anesthesia 9
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Epinephrine; Lidocaine Hydrochloride
Intervention Trials
Pulpitis 26
Pain, Postoperative 26
Acute Pain 10
Lacerations 8
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Epinephrine; Lidocaine Hydrochloride

Trials by Country

Trials by Country for Epinephrine; Lidocaine Hydrochloride
Location Trials
United States 116
Canada 16
Egypt 9
Germany 6
Saudi Arabia 6
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Epinephrine; Lidocaine Hydrochloride
Location Trials
California 23
Pennsylvania 9
New York 9
North Carolina 7
Maryland 7
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Epinephrine; Lidocaine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Epinephrine; Lidocaine Hydrochloride
Clinical Trial Phase Trials
Phase 4 85
Phase 3 22
Phase 2/Phase 3 9
[disabled in preview] 25
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Epinephrine; Lidocaine Hydrochloride
Clinical Trial Phase Trials
Completed 128
Recruiting 26
Not yet recruiting 25
[disabled in preview] 26
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Epinephrine; Lidocaine Hydrochloride

Sponsor Name

Sponsor Name for Epinephrine; Lidocaine Hydrochloride
Sponsor Trials
University of California, San Diego 6
University of North Carolina, Chapel Hill 5
University of California, San Francisco 4
[disabled in preview] 8
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Epinephrine; Lidocaine Hydrochloride
Sponsor Trials
Other 260
Industry 28
U.S. Fed 8
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trials, Market Analysis, and Projections for Epinephrine and Lidocaine Hydrochloride

Introduction to Epinephrine and Lidocaine Hydrochloride

Epinephrine and lidocaine hydrochloride are two critical medications with diverse applications in medical treatment. Epinephrine is primarily used for treating severe allergic reactions, including anaphylaxis, while lidocaine hydrochloride is a local anesthetic used for pain management. Here, we will delve into the current state of clinical trials, market analysis, and future projections for these drugs.

Clinical Trials Update for Epinephrine

Anaphylm Sublingual Epinephrine Film

A significant development in the epinephrine market is the advancement of Anaphylm, a sublingual epinephrine film, by Aquestive Therapeutics. This innovative product aims to provide a convenient, orally delivered alternative to traditional injection-based epinephrine treatments.

  • NDA Submission: Aquestive Therapeutics is on track to submit a New Drug Application (NDA) for Anaphylm in the first quarter of 2025. The FDA has provided positive feedback on the planned submission, including the content, format, and safety evaluation[1][4].
  • Clinical Trials: The company has commenced a pharmacokinetic/pharmacodynamic (PK/PD) pediatric trial, which is a crucial step towards the NDA submission. No additional adult clinical trials are required by the FDA, marking a significant milestone for the company[1][4].
  • Potential Launch: If approved, Anaphylm could be launched in late 2025 or early 2026, offering patients a no-needle, no-device option for treating severe allergic reactions[4].

Ongoing Research and Trials

The epinephrine market is vibrant with ongoing clinical trials. As of September 2024, there were 2,025 clinical trial studies involving epinephrine, with 434 ongoing studies across various phases. These trials are evaluating different drug delivery systems and dosing regimens to enhance the efficacy and safety of epinephrine treatments[3].

Market Analysis for Epinephrine

Market Size and Growth

The epinephrine market is projected to experience substantial growth. In 2023, the market was valued at $2.87 billion and is expected to reach $6.93 billion by 2034, growing at a compound annual growth rate (CAGR) of 8.34%[3].

Driving Factors

  • Increasing Demand: The rising incidence of severe allergic reactions and anaphylaxis drives the demand for epinephrine products.
  • Innovative Delivery Methods: The development of new delivery methods, such as sublingual films and nasal sprays, is expanding the market by offering more convenient and less invasive treatment options[4].

Clinical Trials Update for Lidocaine Hydrochloride

Market Dynamics

Lidocaine hydrochloride, a widely used local anesthetic, is undergoing continuous research and development to enhance its formulations and applications.

  • Regulatory Scrutiny: While the market is growing, it faces challenges from regulatory scrutiny and the need for stringent safety standards. This requires continuous research to address safety concerns and obtain thorough approvals[2][5].
  • Clinical Applications: Lidocaine hydrochloride is extensively used in dental procedures, cosmetic procedures, and postoperative pain management. The versatility of the drug in various formulations like creams and injections further supports its market growth[2][5].

Market Segmentation

The lidocaine hydrochloride market is segmented based on dosage forms, applications, distribution channels, and regions. Dental procedures dominate the application segment, while retail pharmacies are the leading distribution channels[2][5].

Market Analysis for Lidocaine Hydrochloride

Market Size and Growth

The lidocaine hydrochloride market was valued at $512.70 million in 2023 and is anticipated to grow to $838.60 million by 2032, exhibiting a CAGR of 5.7% during the forecast period[2].

Key Drivers

  • Aging Population: The growing elderly population is a significant driver, as this demographic requires more pain management solutions.
  • Technological Advancements: Progress in drug delivery technologies has led to the development of innovative formulations, enhancing the effectiveness and flexibility of lidocaine hydrochloride[2][5].

Regional Dominance

North America leads the global lidocaine hydrochloride market, driven by the increasing number of surgical procedures and the rising demand for pain management solutions in this region[2].

Future Projections

Epinephrine Market

  • Growth Potential: The epinephrine market is expected to see significant growth due to the increasing incidence of severe allergic reactions and the introduction of innovative delivery methods like Anaphylm.
  • Market Expansion: The market will likely expand as more patients seek convenient and effective treatments for anaphylaxis, driving the demand for products like sublingual epinephrine films[3][4].

Lidocaine Hydrochloride Market

  • Sustained Growth: The lidocaine hydrochloride market will continue to grow, driven by the aging population and advancements in drug delivery technologies.
  • Regulatory Balance: To sustain growth, manufacturers must balance meeting demand with addressing regulatory considerations and safety concerns[2][5].

Key Takeaways

  • Epinephrine: The epinephrine market is poised for significant growth with the introduction of new delivery methods like Anaphylm, which could transform the treatment of severe allergic reactions.
  • Lidocaine Hydrochloride: The lidocaine hydrochloride market will continue to grow driven by the aging population and technological advancements, but it must navigate regulatory scrutiny and safety concerns.
  • Innovative Delivery: Both markets are driven by innovations in drug delivery systems, which enhance the convenience, efficacy, and safety of these medications.

FAQs

What is the current status of Anaphylm, the sublingual epinephrine film?

Anaphylm is on track for an NDA submission in the first quarter of 2025, with the FDA providing positive feedback on the planned submission. If approved, it could be launched in late 2025 or early 2026[1][4].

How is the lidocaine hydrochloride market segmented?

The lidocaine hydrochloride market is segmented based on dosage forms (creams, injectables, etc.), applications (dental procedures, cosmetic procedures, etc.), distribution channels (retail pharmacies, etc.), and regions (North America, Europe, etc.)[2][5].

What are the key drivers of the epinephrine market growth?

The key drivers include the increasing incidence of severe allergic reactions, the introduction of innovative delivery methods like sublingual films and nasal sprays, and the growing demand for convenient and effective treatments for anaphylaxis[3][4].

What challenges does the lidocaine hydrochloride market face?

The market faces challenges from regulatory scrutiny, potential side effects, competition from alternative pain management solutions, and the need for continuous research to address safety concerns[2][5].

Which region dominates the global lidocaine hydrochloride market?

North America dominates the global lidocaine hydrochloride market, driven by the increasing number of surgical procedures and the rising demand for pain management solutions in this region[2].

What is the projected growth rate of the epinephrine market?

The epinephrine market is projected to grow at a CAGR of 8.34% from 2023 to 2034, reaching a value of $6.93 billion by 2034[3].

Sources

  1. Patient Care Online: "NDA Submission for Anaphylm (Epinephrine) Sublingual Film on Track for Q1 2025, Company Says"
  2. Polaris Market Research: "Lidocaine Hydrochloride Market Size, Share, Global Analysis Report"
  3. Towards Healthcare: "Epinephrine Market Size, Trends & 8.34% CAGR Rise by 2034"
  4. Healio: "Sublingual epinephrine film moving forward, NDA anticipated by early next year"
  5. Allied Market Research: "Lidocaine Hydrochloride Market - Allied Market Research"

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.