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news.Hovione has submitted its first investigational new drug (IND) application to the US Food and Drug Administration (FDA) for minocycline gel to administer topically one of the most widely prescribed oral antibiotics for acne.
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The IND filing for minocycline gel is part of the company’s strategy to develop improved drug delivery options for established drugs.
Minocycline gel is a new formulation using a new patented crystalline base form of minocycline.
Hovione senior director of Product Development and Licensing Carla Vozone said: "This filing represents a turning point in Hovione’s history. It builds on 50 years of manufacturing Active Pharmaceutical Ingredients, Particle Engineering and Formulation.
"This is a novel route of administration for a drug with proven safety and efficacy over more than 30 years of clinical use.
"We believe the targeted delivery to the site of action will reduce systemic exposure and thus potentially reduce the adverse events profile."
At present, there are no approved topical formulations of minocycline to treat acne.
After securing FDA’s acceptance of the IND submission, the company intends to start human clinical Phase I/II trials in early 2015.