Nasal spray using a new formulation technology cuts down the required dosage of the allergic rhinitis corticosteroid drug budesonide by one-sixth, said Marinomed Biotech AG.
Budesolv is a new formulation of the compound budesonide. Developed using Marinosolv technology platform, Budesolv has demonstrated to be efficient with a six times lower dose of the current marketed product Rhinocort Aqua, according to the phase 3 data announced by the Austrian biopharmaceutical firm.
Unlike steroid nasal sprays which contain largely undissolved suspensions of the active compounds, Marinosolv technology enables the substance to be fully dissolved. Budesolv thus contains a significantly lower concentration of the active ingredient.
The study reported that after one week of treatment, Budesolv 10µg could achieve a similar effect compared to Rhinocort Aqua 64µg . The results revealed improvement in symptoms of allergic rhinitis (hay fever) after the first dose of Budesolv, which was not observed with Rhinocort Aqua.
“Budesolv showed a pronounced reduction of allergic nasal symptoms within four hours compared to the symptoms before the initial dose and to placebo. This efficacy is also apparent for allergic symptoms associated with asthma. In the asthma score, a strong reduction compared to placebo immediately after the initial dose of Budesolv was confirmed. No such effect was observed with the reference product Rhinocort Aqua. Budesolv thus represents the first real innovation in the treatment of allergies with budesonide in many years.” said principal investigator and allergologist Dr. Petra Zieglmayer in the press release.
Marinomed is planning launch Budesolv in the European market in 2021.