Conduct BE study: CDSCO Panel Tells Sun Pharma Labs on COPD drug Umeclidinium powder for inhalation
New Delhi: In line with the proposal to manufacture and market Umeclidinium powder for inhalation 62.5mcg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Sun Pharma Labs to conduct bioequivalence study with pharmacokinetic endpoints for which firm should submit bioequivalence protocol to CDSCO for further review by the committee.
This came after Sun Pharma Labs presented its proposal for a grant of manufacture and marketing of Umeclidinium powder for inhalation 62.5mcg along with justification for waiver of Phase-III clinical trial and bioequivalence study before the committee.
The firm has informed that the proposed drug Umeclidinium powder for inhalation 62.5mcg is already in the USA, UK, EU, Australia, and Canada for Chronic obstructive pulmonary disease.
Umeclidinium is a long-acting muscarinic antagonist (LAMA) used as a maintenance treatment for symptoms of chronic obstructive pulmonary disease (COPD). COPD is a progressive obstructive lung disease characterized by shortness of breath, cough, sputum production, and chronically poor airflow with a forced expiratory volume in 1 second (FEV1) of less than 80%.
Umeclidinium blocks muscarinic M3 receptors. M3 receptors in the lungs mediate bronchoconstriction, so blockade of these receptors leads to bronchodilation.
This medicine will not relieve a COPD attack that has already started. Inhaled umeclidinium is a long-acting bronchodilator. This medicine is breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs.
