Jaguar Health Licenses FDA-Approved Oral Mucositis Product for U.S. Market, Initiating Commercial Footprint in its Core Focus Area of Cancer Supportive Care - Seite 2
"Gelclair is an FDA-approved prescription product and can be commercialized without any clinical development costs for Jaguar," added Conte. "We are expanding our footprint beyond HIV-related supportive care to include cancer-related supportive care, and the in-license of Gelclair is a first building block while we await the forthcoming results from our pivotal Phase 3 OnTarget trial of crofelemer for cancer therapy-related diarrhea, an indication we also refer to as chemotherapy-induced overactive bowel (CIOB) - which includes symptoms such as unpredictable and/or chronic debilitating diarrhea and GI urgency. We live in the age targeted therapies, and thanks to these amazing drugs cancer patients are living longer - 5, 10, 20 years. Targeted therapies often lead to more severe side effects, however, and patients want to live, not just survive."
Oral mucositis can negatively affect diet, nutrition, oral hygiene, and 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, with the incremental cost of oral mucositis exceeding $17,000 for patients with head and neck cancer.4
Gelclair is a clinically proven, 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, swallow, speak and sleep. Gelclair also reduces the need to use parenteral feeding or opiate analgesics.
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.