Marinomed applies for decongestant approval in Europe

Published: 8-Sep-2020

Nasal spray is the first product from the Carragelose platform to be approved as a medicinal product

Marinomed Biotech has applied for approval of the new decongestant Carragelose nasal spray in a first group of EU countries. It is the first product from the Carragelose platform to be approved as a medicinal product.

The spray aims to treat viral infections of the respiratory tract and reduce the swelling of the mucous membranes of the nose and throat, which enables free breathing through the nose. "With this decongestant nasal spray, we are expanding our successful Carragelose product range by including a non-prescription drug for the first time. This will give many people in Europe access to the advantages of Carragelose as a broad-spectrum virus blocker. As a company, we are strengthening our presence in the important market for decongestant nasal sprays," explained CEO Andreas Grassauer.

The nasal spray contains Carragelose and the decongestant xylometazoline. Carragelose forms a moisturizing protective film on the nasal mucosa and thus slows down the spread and multiplication of viruses. In addition, Carragelose supports the active ingredient xylometazoline in reducing the duration and intensity of symptoms in the event of a viral infection of the respiratory tract.

Austria is the reference state in a decentralised marketing authorisation procedure. Marinomed expects the product to be launched in important EU markets in the 2021/22 season. Marinomed has already won two new marketing partners for this product.

The pandemic

Products containing Carragelose have been on the market for several years as nasal sprays, throat sprays and lozenges as therapeutic agents against respiratory infections in more than 40 countries. Because of the solely physical mechanism of action, the products are certified as medical device products and are characterised by their very broad effectiveness against various respiratory viruses.

Several independent studies confirm the effectiveness against SARS-CoV-2. A study from Tennessee / USA together with Argentinean researchers shows that Carragelose can reduce the multiplication of the virus by almost 100% even at extremely low doses. A clinical study, which was also carried out in Argentina, shows that a nasal spray with Carragelose in combination with the drug Ivermectin offers a very high level of protection as a prophylaxis. 229 healthy hospital employees took part in the study. The group treated with Carragelose and Ivermectin did not register a single infection with SARS-CoV-2, while in the control group 11% of the participants tested positive for SARS-CoV-2 within 28 days.

Carragelose has been shown in-vitro to be active against human rhinoviruses, human coronaviruses (SARS-CoV-2, OC43 and 229E), human influenza viruses A (nH1N1 and H3N2), non-human pathogenic influenza A viruses (H7N7 and H5N1), respiratory syncytial virus and human parainfluenza virus type 3.

This broad effectiveness could also be shown clinically in four studies. Patients suffering from early symptoms of influenza infections were treated with a nasal spray containing Carragelose. The results showed that patients treated with the Carragelose-containing nasal spray exhibited significantly shorter symptoms than placebo patients and that the viral load and the recurrence of symptoms were significantly reduced.

A subgroup analysis with those patients who were infected with either human rhinoviruses, human coronaviruses or human influenza A viruses showed that similar results were achieved in all three groups as in the group of all virus-positive patients. The greatest reduction in symptoms was achieved in coronavirus-infected patients who, in the case of treatment with a Carragelose-containing nasal spray, were symptom-free almost 4 days earlier than the comparison group with placebo treatment.

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