Exemed Pharma Gets CDSCO Panel Nod To Study FDC of Montelukast, Bilastine
New Delhi: Exemed Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the bioequivalence (BE) study and Phase III clinical trial of the fixed-dose combination drug Montelukast Sodium plus Bilastine tablets.
This came after Exemed Pharmaceuticals presented the proposal before the committee along with BE study protocol and phase III clinical trial study protocol.
Montelukast is in a class of medications called leukotriene receptor antagonists (LTRAs). 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.
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 helps stop your airways from narrowing (caused by inflammation). This makes breathing easier and prevents asthma attacks. Most people take montelukast once a day in the evening. If you take it for asthma, it's important to take it even when you have no symptoms.
Bilastine is an antihistamine that is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, itchy nose, nasal secretion, nasal congestion, and red, streaming eyes) and other forms of allergic rhinitis. It can also be used to treat itchy skin rashes (wheals or urticaria).
Bilastine is a new oral highly selective H1-receptor antagonist developed for the symptomatic treatment of allergic rhino-conjunctivitis and urticaria. 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 Pulmonary held on 5th July 2023, the expert panel reviewed the proposal presented by Exemed Pharmaceuticals along with BE study protocol and phase III clinical trial study protocol of the FDC pulmonary drug Montelukast Sodium plus Bilastine tablets
After detailed deliberation, the committee recommended the grant of permission to conduct the BE study and phase III clinical trial.
In accordance with the above, the expert panel stated that the firm should present the results of BE study for review by the committee before the initiation of the Phase III clinical trial.
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