Hovione recently announced it has filed an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) for minocycline gel, a novel formulation to administer topically using a new patented crystalline base form of minocycline, one of the most widely prescribed oral antibiotics for acne. This event represents a milestone in Hovione’s strategy of developing improved drug delivery options for established drugs. Currently, says Hovione, approved topical formulations of minocycline for the treatment of acne.
According to a number of online sources, minocycline is a member of the tetracycline family of antibiotics and works by disrupting the production of proteins by bacteria. It is effective against a wide variety of bacteria, including Borrelia recurrentis, Chlamydia trachomatis, Yersinia pestis and Escherichia coli. The FDA approved minocycline in 1971. While oral administration of minocycline has a well-established efficacy and safety profile in acne, explains Hovione, it is also associated with certain adverse events, due to systemic exposure. Minocycline is the most lipid-soluble of the tetracycline-class antibiotics, an attribute, says Wikipedia, which gives the greatest penetration into the prostate and brain, but also the greatest amount of central nervous system (CNS)-related side effects, such as vertigo. Side effects also include diarrhea, skin discoloration and autoimmune disorders not seen with other oral antibiotics in the class.
Pending FDA’s acceptance of the IND submission, Hovione plans to initiate human clinical Phase 1/2 studies in early 2015. “This filing represents a turning point in Hovione’s history. It builds on 50 years of manufacturing active pharmaceutical ingredients, particle engineering and formulation” comments 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.”
With four FDA inspected sites in the U.S., China, Ireland, and Portugal, Hovione says its been leveraging its long experience as a CMO and as a compliant manufacture of APIs and intermediates to support its customers. Able to process highly potent compounds, Hovione offers proprietary product development and licensing opportunities for drug products — especially in the inhalation area.