US WorldMeds Launches GELX® ORAL GEL, a Zinc-Taurine Bioactive Barrier Therapy for Oral Mucositis Caused by Cancer Treatment

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US WorldMeds, LLC

May 04, 2020, 10:00 ET

LOUISVILLE, Ky., May 4, 2020 /PRNewswire/ -- US WorldMeds, LLC announced today the launch of GELX® ORAL GEL, a Zinc-Taurine bioactive barrier therapy for the management and relief of oral pain associated with oral mucositis.1

"With GELX, there's a treatment available that biomechanically protects against intraoral pain," said P. Breckinridge Jones, CEO of US WorldMeds, "and can help many patients manage inflammation of oral mucositis and complete their radiation and chemotherapy cancer treatments." 

Oral Mucositis (OM) is an inflammation and ulceration of the mucosal membranes in the mouth and throat. OM is a common side effect and serious complication for patients receiving radiation and chemotherapy cancer treatments. Over time, OM worsens and can be difficult to manage.2-4

Oral mucositis can significantly disrupt the daily lives of patients. Serious OM complications include intolerable pain and inflammation, increased risk of infections, malnutrition, dehydration, difficulty speaking, and increased use of narcotics. Severe cases of OM may result in the interruption of a patient's oncology treatment schedule, which may compromise the efficacy of cancer therapy and patient survival.2-4  

GELX ORAL GEL is a bioactive therapy that can build an effective barrier against the pain and inflammation of OM. It biomechanically protects against intraoral pain, coating exposed nerve endings and open sores. Through a polyvinylpyrrolidone delivery system, which can improve the release rate and solubility of drugs, GELX supplies the mucosal environment with a bioactive Zinc-Taurine Complex that is known to hinder and delay the inflammatory cycle of oral mucositis.5

"This is a key benefit," said Henry van den Berg, MD, Senior Vice President, US WorldMeds, "because it's very important to avoid delays or hinderances to an already aggressive cancer treatment schedule. By protecting against the pain and inflammation of OM, GELX can help patients maintain their physician-recommended treatment plan." 

The anti-inflammatory effects of GELX technology are well established. Moreover, the combined antiinflammatory properties of zinc and taurine have demonstrated a synergistic biological effect in vitro.5,6

"We are committed to helping cancer patients avoid the painful disruption of OM to their critical radiation and chemotherapy treatments. With the launch of GELX, patients can gain consistent oral pain relief facilitating successful completion of their cancer treatment goals," said P. Breckinridge Jones. "We are proud to support healthcare providers with an option that can help cancer patients manage their OM pain and stick to their treatment schedules." 

GELX is currently available in a 30-day supply of single use, 15mL laminated foil stick packs.  US WorldMeds has established an agreement with Onco360 as the exclusive Specialty Pharmacy Supplier.   

About GELX ORAL GEL

Indication
GELX ORAL GEL has a mechanical action indicated for the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including: Oral Mucositis/Stomatitis (may be caused by chemotherapy or radiotherapy), irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, or disease. Also indicated for diffuse aphthous ulcers.1  GELX, a prescription only therapy:

  • Provides a bioactive Zinc-Taurine Complex that hinders and delays the inflammatory response5
  • Biomechanically protects against intraoral pain
  • Has a safety profile that allows for use throughout the entire treatment cycle5
  • Offers flexible dosing (TID or PRN) for maximum daily relief1
  • Is available in a ready-to-use, alcohol-free formulation1

About US WorldMeds
US WorldMeds is a specialty pharmaceutical company whose products are making a difference in the lives of the patients and communities it serves. US WorldMeds takes an agile and personal approach to pharmaceuticals – pioneering research and product development in therapeutic areas that desperately need new solutions. Headquartered in Louisville, Kentucky, US WorldMeds has global presence and nearly 20 years of experience in the development, licensure, and commercialization of unique products. For more information about US WorldMeds, visit http://www.usworldmeds.com/. Follow US WorldMeds on Twitter, LinkedIn, and on Facebook.

Important Safety Information 

  • GELX is contraindicated in any patient with a known history of hypersensitivity to any of the ingredients.1
  • Patients should not use if stick pack has been opened prior to receipt or is damaged in any way.1
  • Patients should not eat or drink for at least one hour after use.1
  • If no improvement is seen in 7 days, patients are encouraged to consult their physician.1

To report SUSPECTED ADVERSE REACTIONS or product complaints, contact US WorldMeds at 1-888-900-8796. You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information.

References:
1. GELX® ORAL GEL Full Prescribing Information. US WorldMeds, LLC: Louisville, KY. August 2019. 2. The Joanna Briggs Institute for Evidence Based Nursing and Midwifery. Prevention and treatment of oral mucositis in cancer patients. Best Practice Evidence Based Practice Information Sheets for Health Professionals. South Australia, Australia. 1998;2(3):1-6. 3. Kintzel PE. Management of oral mucositis in cancer patients. Clin Oncol News. October 2011:1-7. 4. Silverman S Jr. Diagnosis and management of oral mucositis. Support Oncol.
2007;5(2 suppl 1):13-21. 5. Data on file. US WorldMeds; Louisville, KY: 2019. 6. Pasantes-Morales H, Wright CE, Gaull GE. Protective effect of taurine, zinc and tocopherol on retinol-induced damage in human lymphoblastoid cells. J Nutr. 1984;114(12):2256-2261.

GELX is a registered trademark of Sunstar Suisse SA
US WorldMeds, LLC is the exclusive licensee and distributor of GELX in the United States and its territories.  ©2020 US WorldMeds, LLC. 

All trademarks are property of their respective owners.

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Related Links http://www.gelxus.com  
http://www.usworldmeds.com 

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SOURCE US WorldMeds, LLC