Hovione files its first Investigational New Drug Application with US FDA
For gel formulation of acne treatment mincocycline administered topically
Portuguese active pharmaceutical ingredients manufacturer Hovione has filed its first Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA).
The company said this is a milestone in its strategy of developing improved drug delivery options for established drugs.
The IND was submitted for minocycline gel, a novel formulation using a new patented crystalline base form of minocycline, to administer topically one of the most widely prescribed oral antibiotics for acne. There are currently no approved topical formulations of minocycline for the treatment of acne.
While oral administration of minocycline has a well-established efficacy and safety profile in acne, it is also associated with certain adverse events, due to systemic exposure.
Pending the US regulator's acceptance of the IND submission, Hovione plans to start human clinical Phase I/II studies early next year.
'This filing represents a turning point in Hovione’s history. It builds on 50 years of manufacturing active pharmaceutical ingredients, particle engineering and formulation,' said Carla Vozone, Hovione’s Senior Director of Product Development and Licensing.
'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.'