Cytogen Unveils Oral Mucositis Education With CAPHOSOL
Princeton, NJ - Cytogen Corporation recently announced the launch of Caphosol Relieves Oral Mucositis (CARE OM), an educational support program for patients and caregivers. The announcement comes as Cytogen establishes an expanded market presence for CAPHOSOL, an advanced electrolyte solution indicated in the U.S. as an adjunct to standard oral care in treating oral mucositis (OM) caused by radiation or high dose chemotherapy. CAPHOSOL, a prescription medical device, is also indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause or whether the conditions are temporary or permanent. CAPHOSOL is available through U.S. wholesalers nationwide.
CARE OM
Cytogenas part of its commitment to advancing the treatment and care of cancer patients, announced the launch of CARE OM – a web-based education and support center for patients and caregivers seeking to learn more about OM and CAPHOSOL. In addition to oral mucositis educational material and support information, visitors to CARE OM, located at http://www.caphosol.com/careom, can also download an OM brochure or request a free brochure about OM by mail.
"The CARE OM program is designed to help raise awareness of oral mucositis -- one of the most common and debilitating complications of cancer treatment," said Michael D. Becker, president and chief executive officer of Cytogen Corporation. "As we make CAPHOSOL more widely available in the U.S., our goal is to improve the quality of cancer patients' lives through the effective management of oral mucositis."
Oral complications including mucositis and salivary gland dysfunction are common and often debilitating side effects of cancer therapy. Oral mucositis is estimated to affect more than 400,000 cancer patients each year. Oral mucositis affects approximately 40% of cancer patients who receive chemotherapy, more than 70% of those undergoing conditioning therapy for bone marrow transplantation, and virtually all patients receiving radiation therapy for head and neck cancer.
Cytogen, which acquired the exclusive North American marketing rights to CAPHOSOL from InPharma AS (Norway, private) in October 2006, aims to enhance public awareness of OM, and increase the availability of CAPHOSOL. "Our experience in the medical and radiation oncology markets makes Cytogen well-positioned to spread the word about oral mucositis, and to aggressively expand CAPHOSOL availability to patients who can benefit from its use," added Mr. Becker.
"Oral mucositis is one of the most common and painful side effects we see in our cancer patients," said Athena Papas, DMD, PhD, Tufts University School of Dental Medicine. "We need to raise awareness of oral mucositis among physicians and nurses and increase support for patients and caregivers managing oral mucositis."
About CAPHOSOL
CAPHOSOL, an advanced electrolyte solution, is a U.S. patented, prescription medical device that lubricates the mucosa and helps maintain the integrity of the oral cavity through its mineralizing potential. CAPHOSOL facilitates chewing and speaking; loosens tough mucus and prevents mucous membranes from sticking together. A prospective, double-blind, randomized trial comparing CAPHOSOL to a placebo rinse demonstrated that CAPHOSOL has a significant effect on amerliorating oral mucositis caused by radiation and/or chemotherapy. In patients undergoing a hematopoietic stem cell transplantation (HSCT), it was observed that the frequency, duration and severity of oral mucositis was significantly less in the CAPHOSOL group than in the control group.
A prospective, randomized, double-blind, placebo-controlled trial demonstrated CAPHOSOL to be a significant adjunct in the management of mucositis associated with high-dose chemotherapy and radiation therapy. The trial evaluated 95 patients undergoing hematopoietic stem cell transplantation with the duration and severity of mucositis and requirements for opioid medications prospectively evaluated. Data demonstrated significant decreases in days of mucositis (3.72 vs. 7.20, P=0.001), days of pain (2.86 vs. 7.67, P=0.0001), dose of morphine (30.46 mg vs. 127.96 mg), and days of morphine (1.26 vs. 4.02, P=0.0001) for patients receiving CAPHOSOL as compared to those administered a placebo. The lead investigator for the study was Athena Papas, DMD, PhD, Department of Oral Medicine, Tufts University School of Medicine, Boston, MA and results were published in the April 2003 issue of Bone Marrow Transplantation (Papas et al. Bone Marrow Transplant. 2003 April;31(8):705-12).
CAPHOSOL Indications
CAPHOSOL is indicated in the U.S. as an adjunct to standard oral care in treating oral mucositis caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain. CAPHOSOL is also indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause or whether the conditions are temporary or permanent. CAPHOSOL is an unclassified medical device and is marketed under a 510(k) Pre-market Notification Application.
SOURCE: Cytogen