Asthma is an inflammatory disorder of the airways that causes attacks of wheezing, shortness of breath, chest tightness, and coughing. It affects nearly 26 million people in the United States, seven million of which are children. Asthma is a significant contributor to health care costs, responsible for 8.9 million office visits and 1.9 million asthma related emergency department visits. In 2010 alone, over $11.0 billion worth of asthma products were sold in the United States. The treatment of bronchospasm – the rescue portion of the asthma market – through the use of albuterol resulted in 49.2 million prescriptions of albuterol dispensed in 2012 according to IMS Health.
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. The TriVair™ technology used by TBS-7 provides immediate visual feedback that the dose has been released and inhaled correctly. The Corporation believes that TBS-7, if approved, will be the only available bronchodilator available in the dry powder inhaler format in the United States. This product may benefit patients that have issues coordinating the timing of their inhalation with the actuation of medication from a puffer. Typical inhaled products are characterized by large dose levels of which a small fraction is actually delivered to the lung tissue. TBS-7 is anticipated to lower the overall systemic exposure of medication by delivery of a significant drug percentage to the target tissue, allowing for equal efficacy to currently marketed albuterol products with reduced drug load and safety risks.
Trimel’s investigational new drug application for TBS-7 became effective with the FDA in January 2011. The Corporation is ready to complete formulation development, manufacture clinical supplies and move into Phase II clinical trials pending the receipt of additional financial resources.
TBS-5 – Asthma Maintenance Therapy
TBS-5 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.