New treatment for oral mucositis New treatment for oral mucositis Available treatment options for oral mucositis are limited, despite the fact that this is a well-known and often serious complication of cancer therapy. episil® represents a new treatment concept for intraoral pain associated with oral mucositis. The product consists of a lipid-based liquid that spreads on the oral mucosa and transforms into a strongly bioadhesive and protective film. episil® has been clinically demonstrated to reduce pain and may further protect the mucosal surfaces and decrease the severity of oral mucositis. Product design and mechanism EASY TO USE episil® is a preservative free liquid provided in a convenient ready-to-use, pocket-sized, spray device for intraoral administration. episil® gives pain relief via mechanical barrier action. The product contains a patented mixture of phospholipids and glycerol dioleate. After administration, and in contact with minute quantities of aqueous fluid present in the oral cavity, the lipid mixture self-assembles to form a robust protective lipid membrane that strongly adheres to the oral mucosa.1 Dosage: episil® is administered to the oral cavity using the spray pump and distributed by swirling and with the tongue. The nozzle can be directed towards affected areas in the mouth. The intended use of episil® includes treatment of pain caused by oral mucositis induced by radio- and chemotherapy. episil® causes no systemic side-effects and does not interact with other treatments. episil® forms a FluidCrystal® physical barrier protecting the soar mucosal surfaces. Recommended dose: 1-3 sprays, 2-3 times per day or as needed. Content: Glycerol dioleate, Soy phosphatidylcholine (lecithin), Ethanol, Propylene glycol, Polysorbat 80 and Peppermint oil. Storage: Store at room temperature. Documented bioadhesion ORAL MUCOSITIS episil® has been clinically documented regarding bioadhesion and long-acting retention at oral mucosa. In a phase I/IIa trial with patients undergoing radiation therapy for treatment of head and neck cancer, 5 patients with oral mucositis was given a single dose episil®. 67.5% of the mucosal area was coverage 3 hours after administration.2 Oral mucositis is a painful inflammation and ulceration of the mucosal membranes in the mouth. It is a frequent side-effect of cancer treatment with radiation and chemotherapy. In severe cases, oral mucositis may be treatment limiting with reduction in dosage or delays in the delivery of therapy. 32,5 67,5 Relief of pain from oral mucositis for up to 8 hours In a multicentre, randomized, double-blind, cross-over, single-dose trial with 32 head and neck cancer patients, undergoing radiotherapy, with oral mucositis grades 2-3 ( WHO ), episil® provided an immediate and long acting reduction of intra-oral pain. The effect was clinically and statistically significant, with a measured 40% mean reduction of intra-oral pain and a longlasting effect during at least 8 hours. 3 Oral mucositis can in advanced stages be extremely painful, preventing the patient from eating and requiring hospitalization for re-hydration, opioid pain-medication, and total parenteral nutrition ( TPN ). The destruction of the protective mucous membrane may further place the patient at a serious risk of infection. Pharmacoeconomic impact – Up to 75% of chemotherapy patients suffer from oral mucositis.4 – Over 90 % of head and neck cancer patients develop oral mucositis.4 – Up to 90 % of bone marrow trans plantation patients are affected by oral mucositis.4 Patients with oral mucositis are fourfold more likely to have unplanned breaks in radiotherapy and more than three times more likely to be hospitalised which results in significant health care costs. 5 Mean reduction of oral pain after administration of a single dose of episil® in patients with radiotherapy induced oral mucositis. References 1. Patent EP1848403 Topical Bioadehesive Formulations. 2. Camurus AB. (2006) Oromucosal benzydamine HCl – Comparison of the bioadhesion to the oral mucosa of four liquid crystalline formulations in cancer patients with oral mucositis. Clinical study report HS-05-160. 3. Camurus AB. (2008) A randomized, two-period cross-over study, multi-centre, double-blind, placebo-controlled trial to assess the local analgesic effect of CAM2028 in head-and-neck cancer patients suffering from irradiation-induced oral mucositis. Integrated clinical and statistical report HS-05-161. 4. Epstein, J.B. and Klasser, G. D. (2006) Emerging approaches for prophylaxis and management of oropharyngeal mucositis in cancer therapy. Expert opinion Emerging Drugs 11(2):353-373. 5. Vera-Llonch, M.G.Oster et al. (2006) Oral mucositis in patients undergoing radiation treatment for head and neck carcinoma. Cancer 106(2):329-336. episil® advantages • Clinically demonstrated pain reduction • Long-acting effect duration of at least eight hours • Superior bioadhesion demonstrated in clinical trials • Lipid-layer protection of sore oral mucosa • Demonstrated safety with no systemic effects • Ready to use, pocket-sized, multi-dose device For more information and ordering, contact Camurus AB. © CAMURUS AB® | ADDRESS: Ideon Science Park, Sölvegatan 41, SE -223 70 Lund, Sweden PHONE: +46 46 286 57 30 | E-MAIL: [email protected] | INTERNET: www.camurus.com