Overview
Asthma is an inflammatory disorder of the airways, which causes attacks of wheezing, shortness of breath, chest tightness, and coughing. Asthma affects nearly 24 million people in the United States, seven million of which are children. Asthma is a significant contributor to health care costs, responsible for 10.6 million office visits and 444,000 emergency room hospital admissions. In 2008, over US$11.0 billion in Asthma products were sold in the United States.
TBS-7 – Bronchospasm
TBS-7 is targeted to provide patients with quick relief from Asthma symptoms using a unit-dose dry-powder inhaler to deliver albuterol, a standard treatment in the prevention and treatment of Asthma symptoms. TBS-7 provides immediate visual feedback that the dose has been released and inhaled correctly. Management believes TBS-7 will be the only available bronchodilator available in the dry powder inhaler format in the United States, which may benefit patients that have issues coordinating the timing of their inhalation with the expulsion of medication from a puffer. TBS-7 is anticipated to lower the overall systemic exposure of medication, allowing for equal efficacy to currently marketed albuterol products with reduced safety risks.
Trimel received approval from the FDA for the TBS-7 investigational new drug application (“IND”) in January 2011. The Corporation is in the process of manufacturing clinical supplies and is ready to move into Phase II clinical trials.
TBS-5 – Asthma Maintenance Therapy
TBS-5 is in formulation development. It is intended to provide asthma patients with improved delivery of an underutilized inhaled corticosteroid for the long-term treatment of airway inflammation caused by asthma. The Corporation is working to create an optimal formulation with further development work pending the receipt of additional financial resources.