New Delhi: The drug major Akum Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical trial of Cetirizine Ophthalmic Solution 0.24% w/v.
This came after Akum Pharmaceuticals presented a revised Phase III clinical trial protocol by including a reference arm and justification for sample size before the committee.
Cetirizine, a metabolite of hydroxyzine, is an antihistamine drug. Its main effects are achieved through selective inhibition of peripheral H1 receptors. Cetirizine is a relatively safe and effective medication for treating allergic rhinitis, urticaria, and allergic conjunctivitis. As cetirizine is also available over the counter, prescribers should educate patients on possible side effects, such as drowsiness, fatigue, and dry mouth, while dispensing medicine.
At the SEC meeting for Opthalmology held on 20 September 2023, the expert panel reviewed the revised Phase III clinical trial protocol of Cetirizine Ophthalmic Solution 0.24% w/v, presented by Akum Pharmaceuticals.
The expert panel noted that the firm submitted the protocol by including a reference arm and justification for sample size in light of earlier SEC recommendations dated 25.05.2023.
After detailed deliberation, the committee recommended a grant of permission to conduct the Phase III clinical trial as per the revised protocol presented by the firm.
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