New treatment for oral mucositis

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
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
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.
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.
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.
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