Oral mucositis, also called "chemo mouth," has emerged as the most significant adverse event in oncology according to a National Comprehensive Cancer Network task force
Up to 40% of all patients treated with chemotherapy develop oral mucositis, and this percentage rises to approximately 90% for patients with head and neck cancers treated with chemotherapy and radiotherapy
SAN FRANCISCO, CA / ACCESSWIRE / September 24, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that Jaguar family company Napo Pharmaceuticals (Napo) is exhibiting Gelclair ® , the FDA-approved oral mucositis prescription product, at the American Society for Radiation Oncology (ASTRO) Annual Meeting , which takes place September 29 - October 2, 2024 in Washington, DC. Jaguar plans to begin the U.S. commercial launch in October 2024 for Gelclair.
"Oral mucositis is among the most common, painful, and debilitating cancer treatment-related side effects. Gelclair is a protective gel with 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. Unlike other products for oral mucositis, it is not a numbing agent and does not sting the mouth," said Lisa Conte, Jaguar's president and CEO. "We look forward to driving awareness among oncologists at the ASTRO Annual Meeting about Gelclair and Jaguar's expanding focus on cancer supportive care."
Oral mucositis, also called "chemo mouth," has emerged as the most significant adverse event in oncology according to a National Comprehensive Cancer Network (NCCN) task force. 1 Up to 40% of all patients treated with chemotherapy develop oral mucositis, and this percentage rises to approximately 90% for patients with head and neck cancers treated with chemotherapy and radiotherapy. 2 Of the latter, 19% may end up being hospitalized, experiencing a delay in antineoplastic treatment for high-grade mucositis management, resulting in a reduction of the quality of life, a worse prognosis, and an increase in patient management costs. 2
Oral mucositis can negatively affect diet, nutrition, oral hygiene, as well as quality of life. 3 Its adverse physical, social and psychological impacts on patients are manifest and include the need for total parenteral nutrition, higher risk of systemic infections, increased use of antifungals and opioid analgesics, increased hospitalizations with longer hospital stays, social isolation and depression due to the inability to talk and eat, subsequent dose reductions, treatment interruptions and discontinuations, and as a corollary to dose reductions and treatment interruptions/discontinuations, diminished anti-tumor responses and shorter survival. 1
The economic consequences are far from trivial. In a third-party study, severe mucositis/pharyngitis occurred in 70.1% of 99 patients with head and neck cancer, with the incremental cost of oral mucositis exceeding $17,244 for these patients. 4
Gelclair is a convenient and easy to use gel that provides rapid and long-lasting pain relief and improves the ability of oral mucositis patients to eat, drink, and swallow.
About the American Society for Radiation Oncology
The American Society for Radiation Oncology (ASTRO) is a professional association in radiation oncology that is dedicated to improving patient care through professional education and training, support for clinical practice and health policy standards, advancement of science and research, and advocacy. ASTRO has a membership of more than 10,000 members covering a range of professions including Radiation Oncologist, Radiation Therapists, Medical Dosimetrists Medical Physicists, Radiation Oncology Nurses and Radiation Biologists. Learn more at www.astro.org.
About Gelclair ®
INDICATIONS
GELCLAIR ® 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 radiation therapy), irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, or disease. Also, indicated for diffuse aphthous ulcers.
IMPORTANT SAFETY INFORMATION
Do not use GELCLAIR if there is a known or suspected hypersensitivity to any of its ingredients.
No adverse effects have been reported in clinical trials, although postmarketing reports have included infrequent complaints of burning sensation in the mouth.
If GELCLAIR is swallowed accidentally, no adverse effects are anticipated.
If no improvement is seen within 7 days, a physician should be consulted.
You are encouraged to report negative side effects of prescription medical products to the FDA.
Visit www.fda.gov/safety/medwatch , call 1-855-273-0468 or fill-in the form at this link .
Please see full Prescribing Information at: https://gelclair.com/assets/Gelclair_PI_Decemeber_2021.pdf
About the Jaguar Health Family of Companies
Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi ® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.
For more information about:
Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit www.napopharma.com
Napo Therapeutics, visit napotherapeutics.com
Magdalena Biosciences, visit magdalenabiosciences.com
Visit the Make Cancer Less Shitty patient advocacy program at makecancerlessshitty.com and on X , Facebook & Instagram
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that Napo will exhibit at the 2024 ASTRO Annual Meeting, and Jaguar's expectation that it will begin the U.S. commercial launch in October 2024 for Gelclair. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
1 NCCN Task Force Report: Prevention and Management of Mucositis in Cancer Care. Journal of the National Comprehensive Cancer Network J Natl Compr Canc Netw, 6(S1), S-1-S-21. https://doi.org/10.6004/jnccn.2008.2001
2 Pulito C, Cristaudo A, Porta C, Zapperi S, Blandino G, Morrone A, Strano S. Oral mucositis: the hidden side of cancer therapy. J Exp Clin Cancer Res. 2020 Oct 7;39(1):210. doi: 10.1186/s13046-020-01715-7. PMID: 33028357; PMCID: PMC7542970.
3 Jensen SB, Peterson DE. Oral mucosal injury caused by cancer therapies: current management and new frontiers in research. J Oral Pathol Med. 2014;43(2):81-90.
4 Nonzee NJ, et al. Evaluating the supportive care costs of severe radiochemotherapy-induced mucositis and pharyngitis: results from a Northwestern University Costs of Cancer Program pilot study with head and neck and nonsmall cell lung cancer patients who received care at a county hospital, a Veterans Administration hospital, or a comprehensive cancer care center. Cancer. 2008;113:1146-1152.
CONTACT:
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SOURCE: Jaguar Health, Inc.
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