Not approved as Inhalation suspension for nebulization, Conduct CT: CDSCO Panel Tells Glenmark on Pulmonary FDC

New Delhi: Noting that the proposed fixed-dose combination (FDC) of Glycopyrrolate plus Formoterol Fumarate Dihydrate plus Budesonide (25mcg+20mcg+500 mcg) is not approved as Inhalation suspension (for nebulization), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Glenmark Pharmaceuticals to conduct the clinical trial of the proposed FDC, Glycopyrrolate plus Formoterol Fumarate Dihydrate plus Budesonide (25mcg+20mcg+500 mcg) Inhalation Suspension (for nebulization).

This came after the drug maker Glenmark presented its proposal and the justification in support of bioequivalence (BE) and Phase III clinical trial waiver for Glycopyrrolate plus Formoterol Fumarate Dihydrate plus Budesonide (25mcg+20mcg+500 mcg) Inhalation Suspension (for nebulization) before the committee.

The committee noted that the proposed FDC is not approved as Inhalation suspension (for nebulization).

Budesonide, glycopyrrolate, and formoterol combination is used as long-term maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema

Glycopyrrolate is in a class of medications called anticholinergics. It decreases stomach acid and saliva production by blocking the activity of a certain natural substance in the body. Glycopyrrolate is used to treat peptic ulcers in adults. It is also used to treat chronic, severe drooling caused by certain neurologic disorders (eg, cerebral palsy) in children 3 to 16 years of age. This medicine is an anticholinergic.

Formoterol fumarate inhalation solution is indicated for the long-term, twice daily (morning and evening) administration in maintaining bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

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.

Earlier, at the 77th SEC meeting held on 05.10.2023, the expert panel suggested the firm demonstrate lung deposition of the triple drug combination in inhalation suspension (for nebulization).

Furthermore, the committee stated that the firm should present in-vitro study data for triple drug combination with all three drugs individually in inhalation suspension (for nebulization) and also should present internationally peer-reviewed journals and approval status of the three-drug combination in inhalation suspension (for nebulization).

In light of the above, at the recent SEC meeting for Pulmonary, the pharmaceutical major Glenmark presented their proposal along with the justification before the committee.

The committee noted that the proposed FDC is not approved as Inhalation suspension (for nebulization).

After detailed deliberation, the committee recommended that the firm should conduct a Phase III clinical trial.

Accordingly, the expert panel suggested that the firm should submit a Phase III clinical trial protocol to CDSCO for review by the committee.

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