Cocaine Hydrochloride Nasal Solution for Nasal Procedures
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two nasal solutions, GOPRELTO® (cocaine hydrochloride nasal solution) and NUMBRINO™, to evaluate their safety and effectiveness as numbing agents for nasal procedures. The researchers aim to understand how the body absorbs these solutions, particularly in teens undergoing nasal surgeries or exams. It targets adolescents scheduled for procedures involving their nasal cavities who meet specific health criteria, such as having a healthy oxygen level and no recent history of drug use. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the development of a potentially new standard in nasal procedure care.
Do I need to stop taking my current medications to join the trial?
You may need to stop taking certain medications before joining the trial. Specifically, you cannot use serotonin-norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors, monoamine oxidase inhibitors, certain nasal products, or disulfiram before and during the study. Check with the study team for more details on your specific medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that GOPRELTO® and NUMBRINO™ nasal solutions have FDA approval as numbing agents for nose procedures, confirming their safety for adults. Both solutions contain cocaine hydrochloride, which numbs the nose before medical procedures.
Studies indicate that the maximum dose for both solutions is up to 160 mg, depending on the patient's weight. This dose is applied using cotton soaked in the solution and placed in the nostrils. Although cocaine can raise concerns about misuse, strict medical supervision minimizes risks.
No specific safety data exists for children yet, which ongoing clinical trials aim to uncover. However, since these treatments are approved for adults, they are generally considered safe when used properly. Researchers will closely monitor trial participants for any side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about GOPRELTO® and NUMBRINO™ nasal solutions because they both use cocaine hydrochloride, a powerful anesthetic, to provide rapid numbing for nasal procedures. Unlike traditional numbing agents, which can take longer to take effect and may not be as potent, these solutions work quickly and effectively to numb the nasal tissues. Their 4% concentration allows for precise application and control, with the potential to improve patient comfort and procedural efficiency. This targeted delivery could be a game-changer in enhancing the patient experience during nasal surgeries.
What evidence suggests that this trial's treatments could be effective for nasal procedures?
This trial will compare GOPRELTO® and NUMBRINO™ nasal solutions, both shown in studies to effectively numb the inside of the nose for medical procedures. These treatments use cocaine hydrochloride to reduce sensitivity and pain during procedures. The main goal is immediate pain relief, as patients have reported no pain on a simple pain scale. The FDA has approved both GOPRELTO® and NUMBRINO®, confirming their effectiveness and safety for numbing the nose. This approval makes them reliable options for reducing discomfort during nose-related medical procedures or surgeries.12467
Are You a Good Fit for This Trial?
This trial is for adolescents aged 12-17 who need a nasal diagnostic procedure or surgery. They must be within the normal weight and BMI range for their age, not pregnant, agree to use birth control if sexually active, and have an oxygen saturation of at least 98%. A parent or guardian must consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of GOPRELTO® or NUMBRINO™ nasal solution for anesthesia during diagnostic procedures
Follow-up
Participants are monitored for safety and effectiveness, including vital signs and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- GOPRELTO® Nasal Solution
Trial Overview
The study tests GOPRELTO® and NUMBRINO™ Cocaine Hydrochloride Nasal Solutions as anesthetics in nose-related procedures. It aims to understand how these drugs are processed in the body (pharmacokinetics) and evaluate their safety and tolerability after one dose.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
FDA Approved NUMBRINO™ (cocaine hydrochloride nasal solution, 4%); Up to 160 mg depending on subject's weight; Saturated cottonoid pledgets are applied topically in both nostrils by study personnel
FDA Approved GOPRELTO® (cocaine hydrochloride nasal solution, 4%); Up to 160 mg depending on subject's weight; Saturated cottonoid pledgets are applied topically in both nostrils by study personnel
Find a Clinic Near You
Who Is Running the Clinical Trial?
Noden Pharma
Lead Sponsor
Pharmaceutical Project Solutions, Inc.
Lead Sponsor
Omnivium Pharmaceuticals LLC
Industry Sponsor
LXO Group
Industry Sponsor
Citations
warning: abuse and dependence - accessdata.fda.gov
The effect of GOPRELTO (cocaine hydrochloride) nasal solution on the QTc interval was evaluated in a randomized, positive- and placebo-controlled four-period ...
Pharmacokinetics, Safety, and Tolerability Study of ...
The purpose of this study is to assess the pharmacokinetic (PK) properties, safety, tolerability, and dosing of GOPRELTO® as an anesthetic for diagnostic ...
209575Orig1s000 - accessdata.fda.gov
The primary efficacy endpoints were nasal anesthesia success, defined as immediate analgesia based on a Numeric Pain Rating Scale (NPRS) of 0 ( ...
cocaine - Drug Summary
Cocaine/Cocaine Hydrochloride/GOPRELTO/NUMBRINO Nasal Sol: 4% ... Safety and efficacy have not been established for Goprelto and Numbrino nasal solutions.
Topical Cocaine Hydrochloride Nasal Solution: Anesthetic ...
In this study, a 4% topical cocaine solution was compared to a 6% solution. The primary outcomes studied were the reduction in the incidence and ...
4195367 This label may not be the latest approved by FDA ...
The recommended dose of GOPRELTO is two soaked cottonoid pledgets placed in each nasal cavity, equivalent to 40 mg cocaine hydrochloride per pledget, for a ...
Pharmacokinetics, Safety, and Tolerability of GOPRELTO ...
This open-label, two-arm, single-dose clinical study evaluates the pharmacokinetics, safety, and tolerability of GOPRELTO® (cocaine ...
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