GelX was approved in Europe for the prevention of oral mucositis
May 14, 2018 Milan, Italy: BMG Pharma S.r.l., an innovative specialty pharmaceutical company, is pleased to announce the European regulatory approval for its gelX product to be used for the prevention of oral mucositis.
This new regulatory approval for gelX is the first for a medical product to be used for both the treatment and prevention of oral mucositis in cancer patients.
The approval is based on clinical data, (conducted under Good Clinical Practice (GCP) principles) from 149 adult and pediatric patients showing unique results with 99,3% of patients experiencing prevention or remission of oral mucositis during cancer therapy.
This new approval will allow patients to receive cancer treatment with a significantly reduced chance of developing oral mucositis during that treatment and to reduce the grade of oral mucositis, allowing the opportunity for normal eating and drinking.
Marco Mastrodonato, Founder and CEO of BMG Pharma S.r.l. commented– “We achieved a unique milestone by giving the opportunity to cancer patients to prevent Oral Mucositis in both adults and children, which will allow them to continue with a complete nutritional program while under cancer treatment. GelX will be available through its partners to over 1.1m patients in the 7 major markets, suffering from oral mucositis as a side-effect of cancer and transplants treatment.’’
GelX Oral Gel and GelX Oral Spray are proprietary products of BMG Pharma Srl. which thanks to their innovative formula, alleviate pain in cancer patients, offering unique solutions for chemotherapy & radiation-induced oral mucositis.
About BMG Pharma S.r.l.
BMG Pharma S.r.l. is a specialty pharmaceutical company with its head office in Milan, Italy, leveraging its proprietary technology to develop products that address unmet needs for patients. The Company is currently focused on partnering its product portfolio in cancer supportive care, dermatology, anaemia, gynaecology, oral / nasal care, aesthetics and osteoarthritis. BMG Pharma S.r.l. is dedicated to helping pharma companies in providing valuable and innovative products to patients, pharmacists and physicians.
- The Company’s core areas are:
Bringing innovative products to market quickly with supportive clinical data.Specific & differentiated regulatory strategies for each product as Prescription and OTC Medical Devices in EC and US to allow rapid market introduction.IP protection for most products and technologies.Full involvement in business collaboration and partnering.
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