Access Provides Update On MuGard’s European Launch

Access has provided an update on the European commercial launch of its MuGard, an FDA approved treatment for oral mucositis, a debilitating side effect of radiation treatment and chemotherapy.

The company said that MuGard is commercially launched by Access’ partner, SpePharm, in six European countries including the UK, Germany, Italy, Norway, Greece and Sweden. Access is conducting pre-marketing activities, including ramping of commercial production, with the goal of a commercial launch in the first half of 2010 in the US.

MuGard was granted the CE mark certification in Europe in late 2008 with the labeling ‘prevention and management of the lesions and symptoms of oral mucositis.’

Key findings and feedback from SpePharm’s ongoing commercial launch and patient assessment project include that over 15,000 bottles of MuGard have been used by over 2,000 patients since launch. The European patient population includes adult patients undergoing radiotherapy and/or chemotherapy regimens.

According to the company, initial feedback continues to reflect that MuGard is well accepted by both patients and healthcare professionals as a preventative and curative treatment for oral mucositis.

MuGard is a ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of many anticancer treatments. In a comparison of cancer patients receiving standard mucositis care with those patients receiving MuGard, the incidence and severity of mucositis was lower in the MuGard treated group using a validated scale for the assessment of oral mucositis.