Zydus Healthcare gets CDSCO Panel nod to conduct Phase III CT of Glycopyrrolate plus Indacaterol Metered Dose Inhalation

New Delhi: The Subject Expert Committee (SEC), functional under the Central Drug Standard Control Organization (CDSCO), has granted approval to Zydus Healthcare for conducting the Phase III clinical trial of Glycopyrrolate IP eq. to Glycopyrronium 25 mcg plus Indacaterol Maleate eq. to Indacaterol 55 mcg metered dose inhalation.

This came after Zydus Healthcare presented the proposal along with the Phase III clinical trial protocol before the committee.

The indacaterol and glycopyrrolate combination is used as a long-term maintenance treatment for airflow blockage in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a long-term lung disease that causes bronchospasm (wheezing or difficulty breathing). Indacaterol and glycopyrrolate are long-acting bronchodilators.

Glycopyrronium, also known as glycopyrrolate, is a racemic mixture of two enantiomers. They are both quaternary ammonium compounds and long acting muscarinic antagonists. It is one of the most commonly prescribed anticholinergic medications.

Glycopyrronium binds to muscarinic receptors in bronchial smooth muscle, preventing acetylcholine from binding and causing bronchoconstriction. Glycopyrronium preferentially binds to M3 receptors, which are primarily responsible for bronchoconstriction in COPD. Glycopyrronium can improve lung function, reduce the risk of exacerbations, and relieve breathlessness.

Indacaterol is an inhaled long-acting beta-2 adrenergic agonist used to relax bronchial smooth muscle and improve symptoms and airflow obstruction caused by chronic obstructive pulmonary disease (COPD) and moderate to severe asthma.

Indacaterol works by stimulating adrenergic beta-2 receptors in the smooth muscle of the airways. This causes relaxation of the muscle, thereby increasing the diameter of the airways, which become constricted in asthma and COPD. It is also long-acting due to its high affinity to the lipid raft domains in the airway membrane, so it slowly dissociates from the receptors. Indacaterol also has a high intrinsic efficacy, so it is also very rapid-acting—onset of action occurs within 5 minutes.

At the recent SEC meeting for Pulmonary, the expert panel reviewed the proposal along with the Phase III CT protocol before the committee.

After detailed deliberation, the committee recommended the grant of permission to conduct a Phase III clinical trial.

Accordingly, the expert panel suggested that the revised phase III CT protocol should be submitted to CDSCO for review.

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