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Biotene oral spray
Biotene oral spray provides lubrication and moisture to the oral cavity to relieve symptoms of dry mouth (xerostomia).
Biotene oral spray provides lubrication and moisture to the oral cavity to relieve symptoms of dry mouth (xerostomia). Used for Xerostomia (dry mouth) due to radiation therapy, chemotherapy, Sjögren's syndrome, or other causes.
At a glance
| Generic name | Biotene oral spray |
|---|---|
| Also known as | Biotene, Mouth spray |
| Sponsor | University of Southern California |
| Drug class | Saliva substitute |
| Modality | Small molecule |
| Therapeutic area | Otolaryngology / Oral Health |
| Phase | FDA-approved |
Mechanism of action
Biotene contains a water-based formulation with enzymes (including glucose oxidase, lactoperoxidase, and lysozyme) and electrolytes that mimic natural saliva composition. It provides immediate moisturizing relief and helps maintain oral pH balance and antimicrobial protection in patients with insufficient natural saliva production.
Approved indications
- Xerostomia (dry mouth) due to radiation therapy, chemotherapy, Sjögren's syndrome, or other causes
Common side effects
- Mild oral irritation
- Taste alteration
- Temporary stinging sensation
Key clinical trials
- Evaluation of the Efficacy of 3M Dry Mouth Moisturizing Spray (NA)
- Blinded Dry Mouth Spray Crossover Study (NA)
- Comparing Over-the-counter Dry Mouth Remedies After Radiation (PHASE1)
- Duration of Effect of Biotene Spray in Patients With Dry Mouth (NA)
- A Clinical Study to Evaluate the Efficacy of Three Dry Mouth Relief Products Versus Water (NA)
- Use of Biotene Moisturizing Mouth Spray for Xerostomia Associated With Oral Oxybutynin Use (PHASE4)
- A New Oral salIvary equivAlent Compared to Two moisturizinG Mouth sprAys in Patients With xeRostomiA: NIAGARA Study (PHASE4)
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:
- Biotene oral spray CI brief — competitive landscape report
- Biotene oral spray updates RSS · CI watch RSS
- University of Southern California portfolio CI