Palatin Technologies, Inc. announced that the U.S. Food
and Drug Administration (FDA) has cleared Palatin's request to begin a
Phase 2A proof-of-concept human trial under an Investigational New Drug
(IND) application using a subcutaneously administered formulation of
PL-3994, an NPR-A agonist compound, in development for treatment of
acute exacerbations of asthma.
Palatin is seeking a development and marketing partner for PL-3994, which would include both the proof-of-concept Phase 2A human trial for asthma and development of an inhalation formulation. Palatin does not intend to initiate either the proof-of-concept human trial or preclinical inhalation toxicity studies unless and until an agreement is reached with a development and marketing partner, or Palatin receives funding to support the proof-of-concept Phase 2A human trial or preclinical inhalation toxicity studies from a third party, such as grant funding from an agency of the federal government.
About Acute Exacerbations of Asthma
Acute exacerbations of asthma, also called acute severe asthma, is an ongoing asthma episode in which asthma symptoms do not adequately respond to initial bronchodilator or corticosteroid therapy. Inhaled beta-2 adrenergic receptor agonists, such as albuterol, and inhaled corticosteroids are primary treatments for asthma episodes. Some patients with acute exacerbations of asthma become unresponsive to beta-2 adrenergic receptor agonists, significantly limiting treatment options and increasing risk.
In 2006, the most recent year reported, there were almost 1.7 million emergency room visits due to asthma, with 440,000 hospitalizations attributed to asthma. In 2008, approximately 23.3 million Americans had asthma, with a projected 2010 economic cost in the United States of $20.7 billion, of which the largest single direct medical expenditure, $5.9 billion, is for prescription drugs.
Source: Palatin Technologies, Inc
Acute exacerbations of asthma, also called acute severe asthma, is an ongoing asthma episode in which asthma symptoms do not adequately respond to initial bronchodilator or corticosteroid therapy. Inhaled beta-2 adrenergic receptor agonists, such as albuterol, and inhaled corticosteroids are primary treatments for asthma episodes. Some patients with acute exacerbations of asthma become unresponsive to beta-2 adrenergic receptor agonists, significantly limiting treatment options and increasing risk.
In 2006, the most recent year reported, there were almost 1.7 million emergency room visits due to asthma, with 440,000 hospitalizations attributed to asthma. In 2008, approximately 23.3 million Americans had asthma, with a projected 2010 economic cost in the United States of $20.7 billion, of which the largest single direct medical expenditure, $5.9 billion, is for prescription drugs.
Source: Palatin Technologies, Inc
