Conduct BE study and clinical trial: CDSCO Panel tells Cipla on Formoterol Fumarate Dihydrate, glycopyrronium inhaler

In addition, the expert panel rejected the clinical trial waiver at this stage.

This came after the drug major Cipla presented their proposal along with justification for clinical trial and bioequivalence (BE) study waiver before the committee.

Formoterol is in a class of medications called long-acting beta-agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.

Formoterol is an inhaled beta2-agonist used in the management of Chronic Obstructive Pulmonary Disease (COPD) and asthma that was first approved for use in the United States in 2001. It acts on bronchial smooth muscle to dilate and relax airways and is administered as a racemic mixture of its active (R; R)- and inactive (S;S)-enantiomers.

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

At the recent SEC meeting for Pulmonary held on 5th December 2023, the expert panel reviewed the proposal presented by the drug major Cipla along with the justification for clinical trial (CT) and BE waiver before the committee.

After detailed deliberation, the committee recommended that the firm conduct the BE study with the innovator product as a reference product, and the clinical trial waiver was not considered at this stage.

Accordingly, the expert panel suggested that the BE protocol should be presented before the committee for review.

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