Clinical trials on cancer patients with oral mucositis have demonstrated that there is a strong bioadhesion to the oromucosal surfaces by the lipid film that is formed after administration of episil® oral liquid to the oral cavity. The lipid film protects the sore surfaces and decreases oral pain rapidly and with a long-lasting effect.
In this study, mixtures of SPC/GDO have been investigated in the context of bioadhesion and retention at intraoral mucosal surfaces. In the first part of the study the phase behavior and nanostructural properties of various hydrated and semihydrated SPC/GDO formulations in physiologically relevant environment have been characterized by using synchrotron small-angle X-ray diffraction (SAXD). In the second part, nonclinical and clinical data for different SPC/GDO compositions including a marketed medical device product were presented. Local tolerability of SPC/GDO formulations was assessed in three nonclinical studies in Syrian hamsters, while clinical assessment of intraoral bioadhesion was conducted in a pilot study in head and neck cancer patients undergoing radiotherapy.

The major finding:

  • Lipid liquid crystal-forming systems of SPC and GDO were shown to effectively adhere at mucosal surfaces in the oral cavity for extended periods of time, at least 3 h post-dosing, as seen in a clinical pilot study in HNC patients.

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The study involving 38 patients with the aim of a final sample of 32 evaluable patients investigated intraoral pain intensity before and up to eight hours after intraoral administration of episil® oral liquid alone or episil® oral liquid containing benzydamine.

The study demonstrated that:

  • episil® oral liquid provided rapid and long-lasting pain relief (up to 8 hours)
  • the inclusion of benzydamine did not provide any additional pain relief compared with episil® oral liquid alone
  • patients reported an average 40% decrease in pain score after 1 hour following the administration of episil® oral liquid

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The study involving 12 patients evaluated if oral cryotherapy in combination with episil® oral liquid, during transplantation period, reduces OM severity and duration, oral pain and use of TPN, compared with cryotherapy alone.

The key results of the study:

  • there was no need for TPN in patients treated with episil® oral liquid
  • lower grades of OM were detected in the patient group treated with the combination of episil® oral liquid and cryotherapy compared with the group treated with cryotherapy alone

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A large observational study involving 44 physicians and more than 150 patients was conducted in Germany in 2012/2013. The objective was to confirm the efficacy and safety of episil® oral liquid in a diverse group of patients with cancer (e.g. breast, head and neck, GI and other solid cancer tumor patients).

The key results for the entire patient population:

  • 90% of patients reported oral pain reduction
  • on average 60% decrease in oral pain when eating, swallowing or speaking
  • over 85% of patients reported improved Quality of Life with episil® oral liquid
  • half of the patients could eat solid food already after 5 days of episil® treatment
  • dramatic decrease in OM grade after 5 days of treatment (67% of the patients on OM grade 0-1 on treatment day 5)

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A pilot study involving 10 prospectively collected consecutive out clinic patients with oral cancer. The study was conducted to evaluate the prevention and management of severe oral mucositis and its consequences with a commercially available bioadhesive barrier-forming lipid solution, episil® oral liquid, in patients with oral cancer treated with definitive RT in a clinical setting.

The major finding of the study:

  • episil® oral liquid is well tolerated and the trend towards less feeding tube-dependency and a possible reduction in inpatient time is promising

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An open-label parallel-group study conducted at 12 sites across 4 countries investigated the safety and tolerability of episil® oral liquid plus standard of care (SOC) versus SOC alone on severity and duration of oral mucositis symptoms in patients (n=116) receiving conditioning treatment for hematopoietic stem cell transplantation (HSCT). Patients scheduled for myeloablative or intense reduced-intensity conditioning treatment followed by HSCT (n=116) were randomized 1:1 to SOC (which included basic oral hygiene) or SOC plus episil® treatment. Of the 109 patients (median age 50 years) who received study treatment (intention-to-treat [ITT] population), 23 were excluded from the per-protocol (PP) population because of inadequate compliance (<50% of study days with 100% compliance).   The major findings of the study:
  • WHO Oral Toxicity Score, which reflects oral mucositis severity across the 28 days of treatment, was significantly lower for SOC plus episil® than for SOC alone in the PP population (adjusted mean 0.5 versus 0.7, p=0.028).
  • There was a tendency of faster decrease of WHO scores in SOC + episil® group than in SOC group in the ITT population, and also lower average WHO scores in SOC + episil® group compared to SOC group in the PP population.

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