CDSCO Panel approves Exemed Pharmaceutical to study Montelukast, Bilastine FDC Tablet
New Delhi: Based on the bioequivalence (BE) study report of fixed-dose combination pulmonary drug Montelukast Sodium plus Bilastine tablets presented by Exemed Pharmaceutical, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended the firm to initiate the Phase III clinical trial for the proposed FDC.
This came after Exemed Pharmaceutical presented a BE study report of the FDC Montelukast Sodium I.P. 10mg plus Bilastine 40mg tablets.
Montelukast is in a class of medications called leukotriene receptor antagonists (LTRAs). It works by blocking the action of substances in the body that cause the symptoms of asthma and allergic rhinitis.
Montelukast is used to prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthma in adults and children 12 months of age and older. Montelukast is also used to prevent bronchospasm (breathing difficulties) during exercise in adults and children 6 years of age and older.
Montelukast causes inhibition of airway cysteinyl leukotriene receptors as demonstrated by the ability to inhibit bronchoconstriction due to inhaled LTD4 in asthmatics. Doses as low as 5 mg cause substantial blockage of LTD4-induced bronchoconstriction.
Bilastine is an anti-allergy medicine. It stops the effects of a substance called histamine and this helps to relieve the symptoms of allergies, such as hay fever and urticaria. Exposure to substances such as pollen, animal fur, or house dust mites can cause the body to produce allergic symptoms.
It is an antiallergic agent whose main mechanism of action is the inhibition of immune system reactions mediated by the interaction of histamine on its H1- receptor.
At the recent SEC meeting for the Pulmonary held on 5th October 2023, the expert panel reviewed the BE study report of the pulmonary FDC containing Montelukast Sodium plus Bilastine.
After detailed deliberation, the committee considered the BE study report and recommended initiating a Phase III clinical trial for which permission has already been granted by CDSCO.
In addition to the above, the expert panel stated that the Phase III clinical trial report should be submitted to CDSCO for further review by the committee.
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