Include nebulization methodology, nebulizer types: CDSCO Panel Tells Glenmark pharmaceuticals on Pulmonary FDC
New Delhi: Citing to include nebulization methodology, type of nebulizer, and interface, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the drug major Glenmark Pharmaceuticals to revise the phase III clinical trial study protocol for Glycopyrrolate IP eq. to Glycopyrronium plus Formoterol Fumarate Dihydrate IP eq. to Formoterol Fumarate plus Budesonide IP (25 mcg + 20 mcg + 500 mcg) inhalation suspension for nebulization.
In addition to the above, regarding the inclusion criteria in the study protocol, the expert panel suggested that the firm should include subjects having exposure to biomass fuel smoke in the inclusion criteria.
This came after drug maker Glenmark Pharmaceuticals presented the proposal along with the Phase III clinical trial study protocol before the committee.
Glycopyrrolate plus Formoterol plus Budesonide, a combination of three medicines, is used in the treatment of chronic obstructive pulmonary disease. The combination is used as a long-term maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Glycopyrrolate, also known as glycopyrronium, is an anticholinergic drug. It is a synthetically created quaternary amine with pyridine and a cyclopentane moiety within the compound's structure. Glycopyrrolate has been widely used as a preoperative medication to inhibit salivary glands and respiratory secretions.
Formoterol is an inhaled, long-acting beta2-adrenergic receptor agonist used as a bronchodilator in the management of asthma and COPD. Formoterol is indicated in various formulations for the treatment of asthma and COPD.
Budesonide is a medication used to manage and treat inflammatory diseases, mainly affecting the airways and gastrointestinal tract. It is in the corticosteroid class of medications.
1. The firm should include a nebulization methodology with the type of nebulizer and interface.2. The firm should include subjects having exposure to biomass fuel smoke in the inclusion criteria.
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