Glenmark Gets CDSCO panel nod for Phase IV CT of COPD drug

Written by Dr. Divya Colin Published On 2023-04-22T17:45:10+05:30 | Updated On 16 Oct 2023 2:35 PM IST

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New Delhi: Pharmaceutical major, Glenmark has got the green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV clinical trial of the fixed dose combination (FDC) Glycopyrrolate plus Budesonide plus Formoterol Fumarate dihydrate actuation delivers inhalation aerosol.

However, this approval is subjected to a condition that the follow-up of the study should be up to 06 months, the details of the last visit including the test parameters should be mentioned in 6th month and telephonic follow-up should be done in the 4th and 5th months to assess the symptom analysis so as to rule out any worsening or exacerbation.

This came after the drug major Glenmark presented the Phase IV Clinical trial protocol before the committee as per the condition mentioned in Form CT-23 dated 13.05.2022,

Budesonide, glycopyrrolate, and formoterol combination are used as long-term maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. This medicine helps improve and reduce the number of flare-ups of the symptoms of COPD.

Inhaled budesonide belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It works by preventing inflammation (swelling) in the lungs that causes an asthma attack.

Glycopyrrolate and formoterol are long-acting bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, and trouble breathing by increasing the flow of air through the bronchial tubes.

At the recent SEC meeting for Pulmonary held on March 21st 2023, the expert panel reviewed the Phase IV Clinical trial protocol of the FDC Glycopyrrolate plus Budesonide plus Formoterol Fumarate dihydrate actuation delivers inhalation aerosol.

After detailed deliberation, the committee recommended for conducting the Phase IV CT with the following conditions:

1. The follow-up of the study should be up to 06 months.

2. The details of the last visit including the test parameters should be mentioned at 06 months accordingly.

3. Telephonic follow-up should be done in the 4th and 5th months to assess the symptom analysis so as to rule out any worsening or exacerbation.

In addition, the expert panel suggested that the result of the study should be presented before the committee for review.

Also Read:Conduct PK study for repeated dose and Phase III CT : CDSCO Panel tells Sun Pharma on Psoriatic drug combination

Glenmarkcdscocopd drugBudesonideformoterolglycopyrrolate

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.