Conduct bioequivalence study: CDSCO Panel tells Zydus Healthcare on Glycopyrrolate, Indacaterol Metered dose inhalation
New Delhi: Rejecting the clinical trial waiver proposal, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Zydus Healthcare to conduct a bioequivalence study (BE) of Glycopyrrolate plus Indacaterol Maleate Metered dose inhalation.
This came after Zydus Healthcare presented a proposal along with BE protocol and justification for clinical trial waiver before the committee.
Glycopyrrolate is an anticholinergic agent used to treat hyperhidrosis, severe drooling, and COPD, used with other medications to treat ulcers, and used in anesthesia. 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 is a muscarinic antagonist with the highest affinity for M1 receptors, followed by M3, M2/M4, and M5.
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.
At the recent SEC meeting for Pulmonary held on 5th December 2023, the expert panel reviewed the proposal along with the BE protocol and justification for CT waiver of the FDC Glycopyrrolate plus Indacaterol Maleate Metered dose inhalation presented by drug major Zydus Healthcare.
After detailed deliberation, the committee recommended that the firm should conduct a BE study.
In addition, the expert panel stated, "Clinical trial waiver was not considered at this stage."
Following the above the committee suggested to the firm that the result of the BE study should be presented before the committee for review.
Also Read: Modify phase III clinical trial protocol: CDSCO panel tells Akum Pharma on antidiabetic FDC
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.