Synokem Pharma Gets CDSCO Panel nod to study Anti Allergic Combination Drug

Written by Dr. Divya Colin Published On 2022-10-15T18:00:53+05:30 | Updated On 15 Oct 2022 12:30 PM GMT

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...

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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Synokem PharmaceuticalsmontelukastFexofenadine HClphase 3 trialcdscosec committee

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.