Our goal is to use our proprietary inhalation technologies to enhance the therapeutic benefits and commercial attractiveness of proven drugs in the field of neurology while minimizing risk by capitalizing on their known safety, efficacy and commercialization history. We have proprietary product candidates in development that address large market opportunities.
Our strategy is to commercialize and develop differentiated neurology product candidates that can address significant unmet medical needs and overcome limitations of existing products. The most advanced product candidate is LEVADEX® (dihydroergotamine) inhalation aerosol, an orally inhaled investigational migraine drug for which a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) in May 2011. The FDA issued a Complete Response letter on March 26, 2012 identifying issues relating to chemistry, manufacturing and controls (CMC), manufacturing deficiencies at a third party manufacturer that will need to be resolved to the FDA’s satisfaction, as well as citing the need for additional time to complete review of inhaler usability information.
In addition to our product portfolio, we have partnering opportunities with drug candidates for the treatment of respiratory diseases.
Product opportunities in this area include:
- Nebulized Corticosteroid Particle Technology
- Combination Particle Technology
- Stable Protein and Peptide Particle Technology