Provide in-vivo data, global data: CDSCO Panel Tells Glenmark on Pulmonary FDC in Inhalation Suspension
New Delhi: In reaction to the request for a waiver of bioequivalence (BE) and Phase III clinical trials for the inhalation suspension of the pulmonary drug combination Glycopyrrolate, Formoterol Fumarate Dihydrate, and Budesonide (25mcg+20mcg+500mcg), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the drug major Glenmark Pharmaceuticals to provide both in-vivo study data and global data concerning the Fixed-Dose Combination (FDC) in Inhalation Suspension dosage form.
Furthermore, the expert panel suggested the drug major Glenmark provide published scientific literature in peer-reviewed journals in support of the proposed FDC (fixed dose combination) in the Inhalation suspension dosage form.
This came after the firm presented the proposal along with the request for BE and Phase III clinical trial waiver before the committee.
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 gland and respiratory secretions.
Glycopyrronium is a muscarinic antagonist with the highest affinity for M1 receptors, followed by M3, M2/M4, and M5. Muscarinic receptors M1 to M4 are found in the lung, although M3 is predominantly responsible for bronchoconstriction and airway secretions.
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 in a class of medications called corticosteroids. It works by decreasing inflammation (swelling) in the digestive tract of people who have Crohn's disease or in the kidneys of people with nephropathy.
Budesonide is used to treat Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever). Budesonide is used to decrease protein in the urine in patients with primary immunoglobulin A nephropathy (kidney disease that occurs in some people when too much immunoglobin A builds up in the kidney, causing inflammation).
At the recent SEC meeting for the Pulmonary held on the 5th of September 2023, the expert panel reviewed the proposal along with the request for BE and Phase III clinical trial waiver presented by the drug major Glenmark.
The committee noted that the FDC is approved by CDSCO in a metered-dose inhaler (MDI) and Dry Powder Inhalation (DPI) form. However, the applied formulation is in Inhalation suspension (for Nebulization).
After detailed deliberation, the committee opined the following:
1. The firm has not presented published scientific literature in peer-reviewed journals in support of FDC in the Inhalation suspension dosage form.
2. The firm has not presented any in-vivo study data with respect to FDC in the Inhalation Suspension dosage form.
3. No global data was presented with respect to the FDC in the Inhalation Suspension dosage form.
In view of the above, the expert panel opined that the firm should submit the above data for further review by the committee.
