Double-blind, multicenter, single-dose, placebo- and dose-controlled, parallel-group study conducted in 648 adult subjects undergoing diagnostic procedures and surgeries on or through the mucous membranes of the nasal cavities.
Randomized to receive cocaine hydrochloride nasal solution, 4% (CII) (N=278), cocaine hydrochloride nasal solution 8% (N=275) or placebo (N=95).
Cocaine hydrochloride nasal solution, 4% (CII) group, two 40 mg soaked cottonoid pledgets applied to the septum in each nasal cavity (160 mg cocaine hydrochloride total dose) and left in place for up to 20 minutes. Similarly, pledgets were also applied in placebo group.
Analgesic success was achieved in 77% of cocaine hydrochloride nasal solution, 4% (CII) patients, who had a pain score of 0 with no additional anesthetic or analagesic medication required. The placebo group achieved 15% analgesic success (pain score of 0). Results showed a significant difference in analgesic success between cocaine hydrochloride nasal solution, 4% (CII) and placebo.
The most commonly reported adverse reactions (>1 patient) to occur in the Phase 3 study with cocaine hydrochloride nasal solution, 4% (CII) were headache and epistaxis. Two adverse reactions of headache were severe (table 1).
| System Organ Class / Preferred Term | Cocaine hydrochloride nasal solution, 4% (CII) (N=278) | Placebo (N=95) |
|---|---|---|
| Nervous System Disorders | ||
| Headache | 7 (3%) | 1 (1%) |
| Respiratory, Thoracic, and Mediastinal Disorders | ||
| Epistaxis | 3 (1%) | 0 |
No premature discontinuations due to an adverse event, serious adverse events, or deaths were reported in the Phase 3 clinical study.
Cocaine hydrochloride nasal solution is an ester local anesthetic indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults.
Cocaine hydrochloride nasal solution is a Schedule II controlled substance.
WARNING: ABUSE AND DEPENDENCE. CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence.
Known hypersensitivity to cocaine hydrochloride, other ester-based anesthetics, or any other component of cocaine hydrochloride.
Seizures: Cocaine hydrochloride may lower the convulsive threshold. Monitor patients for development of seizures.
Blood Pressure and Heart Rate Increases: Monitor vital signs, including heart rate and rhythm, in patients after receiving cocaine hydrochloride. Avoid use of cocaine hydrochloride in patients with a recent or active history of uncontrolled hypertension, unstable angina, myocardial infarction, coronary artery disease, or congestive heart failure.
Toxicology Screening: Cocaine hydrochloride and its metabolites may be detected in plasma for up to one week after administration and in urine toxicology screening for longer than one week after administration.
The most common adverse reactions (>0.5%) occurring in patients treated with cocaine hydrochloride were headache and epistaxis.
Disulfiram: Increases plasma cocaine exposure. Avoid using cocaine hydrochloride in patients taking disulfiram.
Epinephrine, Phenylephrine: There have been reports of myocardial ischemia, myocardial infarction, and ventricular arrhythmias with concomitant use during nasal surgery. Avoid use of additional vasoconstrictor agents with cocaine hydrochloride nasal solution. If concomitant use is unavoidable, prolonged vital sign and ECG monitoring may be required.
Pregnancy: May cause fetal harm.
Lactation: Avoid breastfeeding during treatment with cocaine hydrochloride; pump and discard breastmilk for 48 hours after treatment.
Hepatic Impairment: Monitor for adverse reactions such as headache, epistaxis, and clinically relevant increases in heart rate or blood pressure. Do not administer a second dose within 24 hours of the first dose.
No cases of overdose with cocaine hydrochloride were reported in clinical trials. In the case of an overdose, consult with a certified poison control center (1-800-222-1222) for up-to-date guidance and advice for treatment of overdosage. Individual patient response to cocaine varies widely. Toxic symptoms may occur idiosyncratically at low doses.
Please note that this information is not comprehensive. Please visit www.GenusCocaine.com for the full prescribing information for cocaine hydrochloride nasal solution, 4% (CII).
To report SUSPECTED ADVERSE REACTIONS, contact Pharm-Olam at 1-866-511-6754 or the FDA at 1-800-FDA-1088 or through www.fda.gov/medwatch.
