Eight years were necessary for the first product to reach the market. With three products in the late stages of clinical development and one product on the market, Novasorb has now proven the concept that cationic nanoemulsions can effectively treat ophthalmic diseases with no toxicity (tested successfully in over 1,000 patients) and several other advantages (Table 10). Cationorm (Figure 6) was launched on the French market April 2008 and at the time this article is written
more than 550,000 units of treatment were sold in about 10 countries without any pharmacovigilance #Smoothened antagonist keyword# concerns. Cyclokat, Vekacia, and Catioprost could reach the market within a few years following the successful completion of pivotal registration studies. The reasons for the success of the Novasorb technology are multiple. Since the beginning of the formulation Inhibitors,research,lifescience,medical work, the company prioritized the search for only compoundial and ophthalmology accepted excipients, a manufacturing
process which is scalable, and finally the animal models and experimental protocols were designed to carefully screen Inhibitors,research,lifescience,medical and select the formulation with the highest probability of demonstrate clinical safety and efficacy. Figure 6 Cationorm is the first product marketed based on the cationic emulsion technology. Table 10 Key drivers of cationic emulsion technology Novasorb. The Novasorb success story also proves that authorities, particularly European authorities, are relatively open to new delivery approaches Inhibitors,research,lifescience,medical and new technologies as long as efficacy and safety can be conclusively demonstrated according to well-constructed protocols and studies. Novagali Pharma is now pursuing the next generation of cationic nanoemulsions, which will have enhanced pharmacokinetics properties and new original drug products to expand the reach of ophthalmic Inhibitors,research,lifescience,medical indications. Some other improvements such as development of new cationic agents will provide continued support for this promising
and effective means of delivering active molecules. Acknowledgments The authors would like to thank S. Cadillon. All authors of the paper have a direct financial relation with the company Novagali Pharma and the products described in the paper.
Particulate drug delivery systems play an important role ADAMTS5 in the treatment of human disease. Particles such as liposomes, protein nanoparticles, and PLGA microparticles are currently used in marketed drug products using a variety of dosage forms [1, 2]. In particular, particle aerosol inhalation therapy is commonplace for the treatment of respiratory disease. Inhaled therapy using pressurized metered dose inhalers (pMDI), dry powder inhalers (DPI), and nebulizers is an attractive route for treatment of respiratory disease, allowing for local delivery of high concentrations of therapeutics in the lung and avoidance of systemic toxicities associated with oral or injectable therapies [3–6].