Conduct Phase III CT: CDSCO Panel Tells Zydus Healthcare on Glycopyrrolatem plus Indacaterol metered dose inhalation

New Delhi: Considering the bioequivalence study report presented by Zydus Healthcare, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm conduct the Phase III clinical trial of the fixed dose combination (FDC) pulmonary drug Glycopyrrolate plus Indacaterol Maleate metered dose inhalation.

This came after Zydus Healthcare presented a bioequivalence (BE) study report as well as justification for a Phase III clinical trial (CT) waiver before the committee.

Indacaterol and glycopyrrolate combination is used as long-term maintenance treatment of air flow 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 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 bioequivalence (BE) study report as well as justification for a Phase III clinical trial (CT) waiver presented by Zydus Healthcare.

After detailed deliberation, the committee considered the BE study report and opined that the firm needs to conduct a Phase III clinical trial with the proposed FDC.

Accordingly, the expert panel suggested that the Phase III clinical trial protocol should be submitted to CDSCO for further review by the committee.

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