Show lung deposition of triple drug combination in Inhalation Suspension: CDSCO Panel tells Glenmark on Pulmonary FDC Drug
New Delhi: In line with the proposal presented by the drug major Glenmark Pharmaceuticals for the bioequivalence (BE) and Phase III clinical trial waiver for the fixed-dose combination (FDC) of Glycopyrrolate plus Formoterol Fumarate Dihydrate plus Budesonide Inhalation Suspension, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the firm to demonstrate lung deposition of the triple drug combination in inhalation suspension (for nebulization).
In addition, the expert panel stated that the firm should present in-vitro study data for triple drug combinations with all three drugs individually in inhalation suspension (for nebulization). Furthermore, the expert panel suggested that The firm should present internationally peer-reviewed journals and the approval status of the three-drug combinations in inhalation suspension (for nebulization).
This came after the firm presented its proposal along with a request for BE and Phase III clinical trial waiver and justification, supporting literature, and in-vitro study data before the committee.
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 used to treat hyperhidrosis, severe drooling, and Chronic obstructive pulmonary disease (COPD), used with other medications to treat ulcers, and used in anesthesia.
Formoterol is used as a long-term (maintenance) treatment to prevent or decrease breathing problems caused by ongoing lung diseases (chronic obstructive pulmonary disease- COPD, including chronic bronchitis and emphysema). Formoterol belongs to the class of drugs known as long-acting inhaled beta-agonists (LABAs). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. This effect helps to reduce wheezing, coughing, and shortness of breath.
Budesonide is a glucocorticoid that is used to treat inflammatory conditions of the lungs and intestines such as asthma, COPD, Crohn's disease, and ulcerative colitis.
At the recent SEC meeting for pulmonary drugs held on 5th October 2023, the expert panel reviewed the proposal presented by the drug major Glenmark Pharmaceuticals along with a request for BE and Phase III clinical trial waiver and justification, supporting literature, and in-vitro study data of the FDC Pulmonary Drug.
After detailed deliberation, the committee opined the following:
1. To demonstrate lung deposition of the triple drug combination in inhalation suspension (for nebulization)2. The firm should present in-vitro study data for triple drug combination with all the three-drug individually in inhalation suspension (for nebulization)3. The firm should present internationally peer review journals & approval status of the three-drug combination in inhalation suspension (for nebulization).
In view of the above, the committee recommended that the firm should present the documents/justification on aforesaid points before the SEC for further review.
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