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amlexanox · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 0.5% amlexanox oral rinse | EXPERIMENTAL | Patients treated with an oral rinse containing the active 0.5% amlexanox |
| Vehicle | PLACEBO_COMPARATOR | Patients treated with an oral rinse containing no active |
| Name | Type | Description |
|---|---|---|
| amlexanox | DRUG | 0.5% amlexanox oral rinse; use 5 ml every 2-3 hours during the awake hours of each day (a minimum of 6 times each day). The liquid was be swirled around the mouth then to be swallowed. Repeated daily until completion of radiation therapy: approximately 7-8 weeks. |
| Vehicle rinse | DRUG | use 5 ml of the vehicle rinse every 2-3 hours during the awake hours of each day (a minimum of 6 times each day). The liquid is be swirled around the mouth then swallowed. |
Inclusion Criteria: 1. Patient is 18 years of age or older; 2. Patient has a histologically documented diagnosis of cancer of the head and neck region; 3. Patient is about to receive a course of radiation therapy (with or without concomitant chemotherapy) with a planned dose of at least 60 Gy over ...
Amlexanox is an investigational small molecule being studied for the treatment of oral mucositis, a painful inflammation and ulceration of the mouth that can occur as a side effect of radiation therapy for head and neck cancer. It is being developed as a 0.5% oral rinse solution.
Amlexanox is being developed by Abeona Therapeutics Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ABEO. The company is advancing the drug as a potential treatment for oral mucositis in patients undergoing radiation therapy for head and neck cancer.
Amlexanox is in Phase 2 clinical development. It has completed a Phase 2 trial, and it remains an investigational drug that has not been approved by regulatory authorities. The drug is being evaluated for its effects on oral mucositis associated with radiation therapy.
Amlexanox has been studied in one completed Phase 2 clinical trial, identified as NCT01083875. This randomized, double-blind, placebo-controlled study enrolled 58 participants in the United States to evaluate the effects of amlexanox 0.5% oral rinse solution on oral mucositis associated with radiation therapy for head and neck cancer.
Amlexanox is a small molecule that is being studied for its potential to reduce oral mucositis. The specific molecular target of amlexanox has not been disclosed in the available clinical trial information, so its exact mechanism of action in treating oral mucositis is not detailed here.