Synokem Pharma Gets CDSCO Panel nod to study Anti Allergic Combination Drug
New Delhi: Synokem Pharmaceutical has got a go-ahead from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) to conduct Phase III clinical trial for anti allergic combination drug Montelukast (4mg) plus Fexofenadine Hydrochloride (60mg) Suspension.
This came after the firm presented Phase-III CT study protocol of the anti allergic combination drug Montelukast (4mg)plus Fexofenadine Hydrochloride (60mg) Suspension before the committee.
Montelukast plus Fexofenadines is a combination of two drugs, namely Montelukast (leukotriene receptor antagonist) and Fexofenadine (antihistamine).
Children are commonly prescribed Montelukast plus Fexofenadine 4mg/60mg to treat symptoms of allergies such as runny nose, sneezing, itching, swelling, congestion, and watery eyes. It may also help in the treatment of asthma and skin allergies.
Montelukast belongs to the class of leukotriene receptor antagonists that work by blocking the action of chemicals called leukotrienes that are released from the lungs, causing inflammation (swelling) and increased mucus production in the airways. This reduces inflammation, mucus production, and narrowing in the airways.
Fexofenadine belongs to the class of antihistamines (anti-allergic drugs) that works by blocking the action of histamine, a substance responsible for causing allergic reactions. It helps to provide relief from symptoms of allergy such as sneezing, running nose, watery eyes, itching, swelling, and congestion or stiffness.
At the SEC meeting for Pulmonary held on September 29,2022, the expert panel reviewed the phase III clinical trial protocol of anti-allergic combination drug Montelukast (4mg)plus Fexofenadine Hydrochloride (60mg) Suspension presented by the firm.
After detailed deliberation, the committee recommended the grant of permission to conduct the proposed Phase-III clinical trial (CT).
In addition, the committee asked the firm to submit the results of the study of the Phase III clinical trial for further review.
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